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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD047315 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This is a continuation study to KUDOS (NCT00266825). The purpose of this study is to follow-up with participants on the original study to determine if the effects of increasing DHA intake during pregnancy increase cognitive development in 2 to 6 year-old children.
Numerous trials show benefits of postnatal DHA supplementation for visual acuity. There are also numerous observational(not intervention)studies that link higher maternal DHA status during pregnancy to higher cognitive function. Intervention studies that increase DHA exposure during fetal life and that measure cognitive development of infants are lacking; and no study to date has systematically followed children whose mothers were randomly assigned to DHA supplementation to school age with regular 6 month assessments of age-appropriate assessments of cognitive development. The absence of such studies is a serious limitation because there is evidence that differences in cognitive function due to such interventions do not become robust until around age 4 years. Women in the US consume low amounts of DHA compared to other world populations, and this likely means less DHA transfer to the fetus than in many other populations. Prenatal DHA exposure may be more important than postnatal exposure, because animal studies show critical windows for brain DHA accumulation in relation to effects on neurotransmitters such as serotonin, dopamine and GABA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Capsule | Placebo Comparator |
| |
| DHA Capsule | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHA | Drug | 600 mg DHA capsule |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ | The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15. | 36 Months |
| Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ | The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15. | 48 Months |
| Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ | The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15. | 72 Months |
| Cognitive Function Score - Peabody Picture Vocabulary Test | The Peabody Picture Vocabulary Test, 3rd Edition provides a standardized assessment of a person's receptive vocabulary. The Standard Score can range from 40 (poorest performance) to 160 (best performance) and has been normed to a Mean = 100, St Dev = 15. |
| Measure | Description | Time Frame |
|---|---|---|
| Adaptive Regulation Assessment | The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10. |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | 2 years |
| Anthropometrics: Weight-for-age |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan E Carlson, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31004139 | Derived | Colombo J, Shaddy DJ, Gustafson K, Gajewski BJ, Thodosoff JM, Kerling E, Carlson SE. The Kansas University DHA Outcomes Study (KUDOS) clinical trial: long-term behavioral follow-up of the effects of prenatal DHA supplementation. Am J Clin Nutr. 2019 May 1;109(5):1380-1392. doi: 10.1093/ajcn/nqz018. | |
| 30794304 | Derived | Kerling EH, Hilton JM, Thodosoff JM, Wick J, Colombo J, Carlson SE. Effect of Prenatal Docosahexaenoic Acid Supplementation on Blood Pressure in Children With Overweight Condition or Obesity: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e190088. doi: 10.1001/jamanetworkopen.2019.0088. |
| Label | URL |
|---|---|
| Main KUDOS Study Posting on Clinicaltrials.gov | View source |
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Participants were required to have been enrolled in the parent trial.
Participants were recruited from 7/17/2008 to 4/24/2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Capsule | Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA |
| FG001 | DHA Capsule | DHA: 600 mg DHA capsule |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Families who completed the parent trial were offered enrollment when their child was 2 yrs of age.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Capsule | Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA |
| BG001 | DHA Capsule | DHA: 600 mg DHA capsule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ | The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15. | Missing data for participants dues to attrition, missed appointments, refusals, or questionable test. | Posted | Mean | Standard Deviation | units on a scale | 36 Months |
|
Not provided
Adverse events were not analyzed as part of this follow up.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Capsule | Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA |
Not provided
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Carlson, PhD | University of Kansas Medical Center | (913) 588-5359 | SCARLSON@kumc.edu |
Not provided
| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
Not provided
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| Placebo Capsule | Drug | 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA |
|
| 60 Months |
| Cognitive Function Score - Test of Preschool Early Literacy | The Test of Preschool Early Literacy provides a standardized Early Literacy Index score, a measure of general, early literacy skills that relate to later reading and writing skill acquisition. The score is based on assessments of vocabulary, print knowledge, and phonological awareness. The score can range from 40 (poorest performance) to 144 (best performance) and has been normed to a Mean = 100, St Dev = 15. | 42 Months |
| Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ | The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15. | 36 Months |
| Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ | The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15. | 48 Months |
| Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ | The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15. | 72 Months |
| 36 Months |
| Adaptive Regulation Assessment | The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10. | 48 Months |
| Adaptive Regulation Assessment | The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10. | 60 Months |
| Adaptive Regulation Assessment | The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10. | 72 Months |
Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). |
| 2.5 years |
| Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | 3 years |
| Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | 2 years |
| Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | 3.5 years |
| Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | 4 years |
| Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | 4.5 years |
| Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | 5 years |
| Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | 5.5 years |
| Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | 6 years |
| Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | 2.5 years |
| Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | 3 years |
| Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | 3.5 years |
| Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | 4 years |
| Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | 4.5 years |
| Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | 5 years |
| Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | 5.5 years |
| Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | 6 years |
| Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | 2 years |
| Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | 2.5 years |
| Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | 3 years |
| Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | 3.5 years |
| Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | 4 years |
| Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | 4.5 years |
| Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | 5 years |
| Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | 5.5 years |
| Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | 6 years |
| Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | 2 years |
| Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | 2.5 years |
| Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | 3 years |
| Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | 3.5 years |
| Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | 4 years |
| Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | 4.5 years |
| Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | 5 years |
| Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | 5.5 years |
| Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | 6 years |
| Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | 2 years |
| Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | 2.5 years |
| Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | 3 years |
| Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | 3.5 years |
| Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | 4 years |
| Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | 4.5 years |
| Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | 5 years |
| Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | 5.5 years |
| Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | 6 years |
| Systolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | 4 years |
| Systolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | 4.5 years |
| Systolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | 5 years |
| Systolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | 5.5 years |
| Systolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | 6 years |
| Diastolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | 4 years |
| Diastolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | 4.5 years |
| Diastolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | 5 years |
| Diastolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | 5.5 years |
| Diastolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | 6 years |
| Heart Rate | Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | 4 years |
| Heart Rate | Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | 4.5 years |
| Heart Rate | Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | 5 years |
| Heart Rate | Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | 5.5 years |
| Heart Rate | Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | 6 years |
| Withdrawal by Subject |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| OG001 | DHA Capsule | DHA: 600 mg DHA capsule |
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| Primary | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ | The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15. | Missing data for participants dues to attrition, missed appointments, refusals, or questionable test. | Posted | Mean | Standard Deviation | units on a scale | 48 Months |
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| Primary | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ | The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15. | Missing data for participants dues to attrition, missed appointments, refusals, or questionable test. | Posted | Mean | Standard Deviation | units on a scale | 72 Months |
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| Primary | Cognitive Function Score - Peabody Picture Vocabulary Test | The Peabody Picture Vocabulary Test, 3rd Edition provides a standardized assessment of a person's receptive vocabulary. The Standard Score can range from 40 (poorest performance) to 160 (best performance) and has been normed to a Mean = 100, St Dev = 15. | Missing data due to attrition, missed appointments, refusals, or questionable test. | Posted | Mean | Standard Deviation | units on a scale | 60 Months |
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| Primary | Cognitive Function Score - Test of Preschool Early Literacy | The Test of Preschool Early Literacy provides a standardized Early Literacy Index score, a measure of general, early literacy skills that relate to later reading and writing skill acquisition. The score is based on assessments of vocabulary, print knowledge, and phonological awareness. The score can range from 40 (poorest performance) to 144 (best performance) and has been normed to a Mean = 100, St Dev = 15. | Missing data due to attrition, missed appointments, refusals, or questionable test. | Posted | Mean | Standard Deviation | units on a scale | 42 Months |
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| Primary | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ | The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15. | Missing data due to attrition, missed appointments, refusals, or questionable test | Posted | Mean | Standard Deviation | units on a scale | 36 Months |
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| Primary | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ | The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15. | Missing data due to attrition, missed appointments, refusals, or questionable test | Posted | Mean | Standard Deviation | units on a scale | 48 Months |
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| Primary | Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ | The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15. | Missing data due to attrition, missed appointments, refusals, or questionable test | Posted | Mean | Standard Deviation | units on a scale | 72 Months |
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| Secondary | Adaptive Regulation Assessment | The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10. | Missing data due to attrition, missed appointments, refusals. | Posted | Mean | Standard Deviation | T-scores | 36 Months |
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| Secondary | Adaptive Regulation Assessment | The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10. | Missing data due to attrition, missed appointments, refusals. | Posted | Mean | Standard Deviation | T-scores | 48 Months |
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| Secondary | Adaptive Regulation Assessment | The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10. | Missing data due to attrition, missed appointments, refusals. | Posted | Mean | Standard Deviation | T-scores | 60 Months |
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| Secondary | Adaptive Regulation Assessment | The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10. | Missing data due to attrition, missed appointments, refusals. | Posted | Mean | Standard Deviation | T-scores | 72 Months |
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| Other Pre-specified | Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Kilogram (kg) | 2 years |
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| Other Pre-specified | Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Kilogram (kg) | 2.5 years |
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| Other Pre-specified | Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Kilogram (kg) | 3 years |
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| Other Pre-specified | Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 2 years |
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| Other Pre-specified | Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Kilogram (kg) | 3.5 years |
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| Other Pre-specified | Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Kilogram (kg) | 4 years |
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| Other Pre-specified | Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | Posted | Mean | Standard Deviation | Kilogram (kg) | 4.5 years |
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| Other Pre-specified | Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Kilogram (kg) | 5 years |
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| Other Pre-specified | Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Kilogram (kg) | 5.5 years |
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| Other Pre-specified | Anthropometrics: Weight-for-age | Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA). | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Kilogram (kg) | 6 years |
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| Other Pre-specified | Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 2.5 years |
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| Other Pre-specified | Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 3 years |
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| Other Pre-specified | Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 3.5 years |
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| Other Pre-specified | Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 4 years |
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| Other Pre-specified | Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 4.5 years |
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| Other Pre-specified | Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 5 years |
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| Other Pre-specified | Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 5.5 years |
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| Other Pre-specified | Anthropometrics: Height-for-Age | Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 6 years |
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| Other Pre-specified | Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Body mass index (kg/m^2) | 2 years |
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| Other Pre-specified | Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Body mass index (kg/m2) | 2.5 years |
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| Other Pre-specified | Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Body mass index (kg/m2) | 3 years |
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| Other Pre-specified | Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Body mass index (kg/m2) | 3.5 years |
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| Other Pre-specified | Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Body mass index (kg/m2) | 4 years |
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| Other Pre-specified | Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Body mass index (kg/m2) | 4.5 years |
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| Other Pre-specified | Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Body mass index (kg/m2) | 5 years |
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| Other Pre-specified | Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Body mass index (kg/m2) | 5.5 years |
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| Other Pre-specified | Anthropometrics: Body Mass Index-for-age | Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Body mass index (kg/m2) | 6 years |
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| Other Pre-specified | Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 2 years |
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| Other Pre-specified | Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 2.5 years |
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| Other Pre-specified | Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 3 years |
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| Other Pre-specified | Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 3.5 years |
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| Other Pre-specified | Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 4 years |
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| Other Pre-specified | Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 4.5 years |
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| Other Pre-specified | Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 5 years |
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| Other Pre-specified | Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 5.5 years |
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| Other Pre-specified | Anthropometrics: Head Circumference-for-age | Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Centimeters (cm) | 6 years |
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| Other Pre-specified | Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | Missing data due to attrition, missed appointments, refusals or questionable intake | Posted | Mean | Standard Deviation | kilocalorie | 2 years |
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| Other Pre-specified | Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | Missing data due to attrition, missed appointments, refusals or questionable intake | Posted | Mean | Standard Deviation | kilocalorie | 2.5 years |
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| Other Pre-specified | Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | Missing data due to attrition, missed appointments, refusals or questionable intake | Posted | Mean | Standard Deviation | kilocalorie | 3 years |
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| Other Pre-specified | Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | Missing data due to attrition, missed appointments, refusals or questionable intake | Posted | Mean | Standard Deviation | kilocalorie | 3.5 years |
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| Other Pre-specified | Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | Missing data due to attrition, missed appointments, refusals or questionable intake | Posted | Mean | Standard Deviation | kilocalorie | 4 years |
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| Other Pre-specified | Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | Missing data due to attrition, missed appointments, refusals or questionable intake | Posted | Mean | Standard Deviation | kilocalorie | 4.5 years |
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| Other Pre-specified | Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | Missing data due to attrition, missed appointments, refusals or questionable intake | Posted | Mean | Standard Deviation | kilocalorie | 5 years |
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| Other Pre-specified | Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | Missing data due to attrition, missed appointments, refusals or questionable intake | Posted | Mean | Standard Deviation | kilocalorie | 5.5 years |
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| Other Pre-specified | Dietary Intake | Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only. | Missing data due to attrition, missed appointments, refusals or questionable intake | Posted | Mean | Standard Deviation | kilocalorie | 6 years |
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| Other Pre-specified | Systolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | 4 years |
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| Other Pre-specified | Systolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | 4.5 years |
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| Other Pre-specified | Systolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | 5 years |
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| Other Pre-specified | Systolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | 5.5 years |
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| Other Pre-specified | Systolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | 6 years |
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| Other Pre-specified | Diastolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | 4 years |
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| Other Pre-specified | Diastolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | 4.5 years |
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| Other Pre-specified | Diastolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | 5 years |
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| Other Pre-specified | Diastolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | 5.5 years |
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| Other Pre-specified | Diastolic Blood Pressure | Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | 6 years |
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| Other Pre-specified | Heart Rate | Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Beats per minute (BPM) | 4 years |
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| Post-Hoc | Anthropometrics: Body Composition | Child body composition was measured between 5 and 6 years of age by BOD POD air displacement plethysmography (COSMED, Concord, CA, USA). Methods adhered to standard testing protocol (tight-fitting one-piece swimsuit and swim cap, duplicate or triplicate measure of body volume and predicted thoracic gas volume). Fat and fat free mass to the nearest 0.1 kg are presented as means with standard deviations. Normative data are not available in this pediatric population. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Kilogram (kg) | 5 to 5.5 years old |
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| Other Pre-specified | Heart Rate | Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Beats per minute (BPM) | 4.5 years |
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| Other Pre-specified | Heart Rate | Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Beats per minute (BPM) | 5 years |
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| Other Pre-specified | Heart Rate | Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Beats per minute (BPM) | 5.5 years |
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| Other Pre-specified | Heart Rate | Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures. | Missing data due to attrition, missed appointments or refusals | Posted | Mean | Standard Deviation | Beats per minute (BPM) | 6 years |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | DHA Capsule | DHA: 600 mg DHA capsule | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| Behavioral Symptoms |
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| Adaptive Skills |
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| Behavioral Symptoms |
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| Adaptive Skills |
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| Behavioral Symptoms |
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| Adaptive Skills |
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| Behavioral Symptoms |
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| Adaptive Skills |
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