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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK099175 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to measure energy intake and energy expenditure during and after pregnancy. The investigators hypothesize that obese pregnant women with weight gain above the Institute of Medicine (IOM) guidelines, 'High Gainers', will have increased energy intake but no evidence for changes in energy expenditure after adjustment for the weight gained when compared to women with appropriate gestational weight gain, 'Normal Gainers'. Additionally, the investigators will measure the babies born to the pregnant women enrolled in MomEE at one time point before 10 days of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant | Obese pregnant women |
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| Measure | Description | Time Frame |
|---|---|---|
| Energy Intake | Energy intake is determined using the energy intake-balance method. Energy intake was calculated as the sum of energy expenditure by doubly labeled water and energy deposition of fat and fat-free tissues by 3 compartment model using plethysmography and isotope dilution. | Approximately 6 months (from 13-16 weeks gestation to 35-37 weeks gestation) |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | Physical activity is determined using daily mean amplitude deviation in milligrams by wrist worn accelerometer over a period of approximately 7 days within early pregnancy (13-16 weeks gestation). Mean amplitude deviation describes the mean distance of data points from the mean, and higher values denote higher levels of physical activity. | Approximately 7 days within 13-16 weeks gestation |
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Inclusion Criteria:
Exclusion Criteria:
Clinical
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75 obese, pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Leanne M Redman, PhD | Pennington Biomedical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34994169 | Derived | Lindsay KL, Most J, Buehler K, Kebbe M, Altazan AD, Redman LM. Maternal mindful eating as a target for improving metabolic outcomes in pregnant women with obesity. Front Biosci (Landmark Ed). 2021 Dec 30;26(12):1548-1558. doi: 10.52586/5048. | |
| 31905403 | Derived | Most J, Altazan AD, St Amant M, Beyl RA, Ravussin E, Redman LM. Increased Energy Intake After Pregnancy Determines Postpartum Weight Retention in Women With Obesity. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1601-11. doi: 10.1210/clinem/dgz330. |
| Label | URL |
|---|---|
| Reproductive Endocrinology \& Women's Health Laboratory- Our Research | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregnant Women With Excess Gestational Weight Gain | Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines |
| FG001 | Pregnant Women With Recommended Gestational Weight Gain | Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines |
| FG002 | Pregnant Women With Inadequate Gestational Weight Gain | Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines |
| FG003 | Pregnant Women Not Included in Analysis | Pregnant women who enrolled in the study but were not included in data analysis for various reasons. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnant Women With Excess Gestational Weight Gain | Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines |
| BG001 | Pregnant Women With Recommended Gestational Weight Gain |
| 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 | Energy Intake | Energy intake is determined using the energy intake-balance method. Energy intake was calculated as the sum of energy expenditure by doubly labeled water and energy deposition of fat and fat-free tissues by 3 compartment model using plethysmography and isotope dilution. | Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis). Reasons include the following: missing necessary data from either the 13-16 weeks gestation or 35-37 weeks gestation visit, pre-eclampsia, or unreliable data. | Posted | Mean | Standard Deviation | kilocalories per day | Approximately 6 months (from 13-16 weeks gestation to 35-37 weeks gestation) |
|
1 year 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregnant Women With Excess Gestational Weight Gain | Pregnant women with weight gain above the Institutes of Medicine gestational weight gain guidelines |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Miscarriage or Pregnancy Loss | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold/sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
Eighteen women who enrolled in the study were not included in analysis for various reasons. The reasons included: missing data from 13-16 gestational week visit, miscarriage, lost to follow-up, preterm delivery, pre-eclampsia, unreliable data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leanne Redman | Pennington Biomedical Research Center | 2257630947 | Leanne.Redman@pbrc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 29, 2018 | Jan 3, 2020 | Prot_SAP_000.pdf |
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Placenta, Cord Blood, fasting Urine, fasting Maternal plasma and serum (during pregnancy and postpartum).
| Physical Activity | Physical activity is determined using daily mean amplitude deviation in milligrams by wrist worn accelerometer over a period of approximately 7 days within late pregnancy (35-37 weeks gestation). Mean amplitude deviation describes the mean distance of data points from the mean, and higher values denote higher levels of physical activity. | Approximately 7 days within 35-37 weeks gestation |
| Energy Expenditure During Sleep | Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within early pregnancy (13-16 weeks gestation). | 1 day within 13-16 weeks gestation |
| Energy Expenditure During Sleep | Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within late pregnancy (35-37 weeks gestation). | 1 day within 35-37 weeks gestation |
| Percentage of Protein of Energy Intake | Percentage of protein of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation). | Approximately 7 days within 13-16 weeks gestation |
| Percentage of Protein of Energy Intake | Percentage of protein of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation). | Approximately 7 days within 35-37 weeks gestation |
| Percentage of Fat of Energy Intake | Percentage of fat of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation). | Approximately 7 days within 13-16 weeks gestation |
| Percentage of Fat of Energy Intake | Percentage of fat of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation). | Approximately 7 days within 35-37 weeks gestation |
| Percentage of Carbohydrate of Energy Intake | Percentage of carbohydrate of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation). | Approximately 7 days within 13-16 weeks gestation |
| Percentage of Carbohydrate of Energy Intake | Percentage of carbohydrate of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation). | Approximately 7 days within 35-37 weeks gestation |
| 31369400 | Derived | Most J, Amant MS, Hsia DS, Altazan AD, Thomas DM, Gilmore LA, Vallo PM, Beyl RA, Ravussin E, Redman LM. Evidence-based recommendations for energy intake in pregnant women with obesity. J Clin Invest. 2019 Aug 1;129(11):4682-4690. doi: 10.1172/JCI130341. |
| 31367759 | Derived | Most J, Redman LM. Energy expenditure predictions in postpartum women require adjustment for race. Am J Clin Nutr. 2019 Aug 1;110(2):522-524. doi: 10.1093/ajcn/nqz087. No abstract available. |
| 29797559 | Derived | Most J, Vallo PM, Gilmore LA, St Amant M, Hsia DS, Altazan AD, Beyl RA, Ravussin E, Redman LM. Energy Expenditure in Pregnant Women with Obesity Does Not Support Energy Intake Recommendations. Obesity (Silver Spring). 2018 Jun;26(6):992-999. doi: 10.1002/oby.22194. |
| 29767680 | Derived | Most J, Gilmore LA, Altazan AD, St Amant M, Beyl RA, Ravussin E, Redman LM. Propensity for adverse pregnancy outcomes in African-American women may be explained by low energy expenditure in early pregnancy. Am J Clin Nutr. 2018 Jun 1;107(6):957-964. doi: 10.1093/ajcn/nqy053. |
| 29659958 | Derived | Most J, Vallo PM, Altazan AD, Gilmore LA, Sutton EF, Cain LE, Burton JH, Martin CK, Redman LM. Food Photography Is Not an Accurate Measure of Energy Intake in Obese, Pregnant Women. J Nutr. 2018 Apr 1;148(4):658-663. doi: 10.1093/jn/nxy009. |
| 28178062 | Derived | Sutton EF, Cain LE, Vallo PM, Redman LM. Strategies for Successful Recruitment of Pregnant Patients Into Clinical Trials. Obstet Gynecol. 2017 Mar;129(3):554-559. doi: 10.1097/AOG.0000000000001900. |
| Miscarriage |
|
| Lost to Follow-up |
|
| Preterm delivery |
|
| Pre-eclampsia |
|
| Unreliable Data |
|
Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines
| BG002 | Pregnant Women With Inadequate Gestational Weight Gain | Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines |
| BG003 | Pregnant Women Not Included in Analysis | Pregnant women who enrolled in the study but were not included in data analysis for various reasons. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Parity | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Highest Education | Count of Participants | Participants |
|
| OG001 | Pregnant Women With Recommended Gestational Weight Gain | Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines |
| OG002 | Pregnant Women With Inadequate Gestational Weight Gain | Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines |
| OG003 | Pregnant Women Not Included in Analysis | Pregnant women who enrolled in the study but were not included in data analysis for various reasons. |
|
|
| Secondary | Physical Activity | Physical activity is determined using daily mean amplitude deviation in milligrams by wrist worn accelerometer over a period of approximately 7 days within early pregnancy (13-16 weeks gestation). Mean amplitude deviation describes the mean distance of data points from the mean, and higher values denote higher levels of physical activity. | Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis). Reasons include the following: missing necessary data from either the 13-16 weeks gestation or 35-37 weeks gestation visit, pre-eclampsia, or unreliable data. | Posted | Mean | Standard Deviation | milligrams | Approximately 7 days within 13-16 weeks gestation |
|
|
|
| Secondary | Physical Activity | Physical activity is determined using daily mean amplitude deviation in milligrams by wrist worn accelerometer over a period of approximately 7 days within late pregnancy (35-37 weeks gestation). Mean amplitude deviation describes the mean distance of data points from the mean, and higher values denote higher levels of physical activity. | Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis). Reasons include the following: missing necessary data from either the 13-16 weeks gestation or 35-37 weeks gestation visit, pre-eclampsia, or unreliable data. | Posted | Mean | Standard Deviation | milligrams | Approximately 7 days within 35-37 weeks gestation |
|
|
|
| Secondary | Energy Expenditure During Sleep | Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within early pregnancy (13-16 weeks gestation). | Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis). Reasons include the following: missing necessary data from either the 13-16 weeks gestation or 35-37 weeks gestation visit, pre-eclampsia, or unreliable data. | Posted | Mean | Standard Deviation | kilocalories per day | 1 day within 13-16 weeks gestation |
|
|
|
| Secondary | Energy Expenditure During Sleep | Energy expenditure during sleep is determined by 1 overnight stay in a whole body calorimeter within late pregnancy (35-37 weeks gestation). | Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis). Reasons include the following: missing necessary data from either the 13-16 weeks gestation or 35-37 weeks gestation visit, pre-eclampsia, or unreliable data. | Posted | Mean | Standard Deviation | kilocalories per day | 1 day within 35-37 weeks gestation |
|
|
|
| Secondary | Percentage of Protein of Energy Intake | Percentage of protein of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation). | Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis) for various reasons. In the analyzed Arms, some participants were not analyzed as energy intake by remote food photography method was less than 60% of the total energy expenditure during that period. | Posted | Mean | Standard Deviation | percentage of energy intake | Approximately 7 days within 13-16 weeks gestation |
|
|
|
| Secondary | Percentage of Protein of Energy Intake | Percentage of protein of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation). | Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis) for various reasons. In the analyzed Arms, some participants were not analyzed as energy intake by remote food photography method was less than 60% of the total energy expenditure during that period. | Posted | Mean | Standard Deviation | percentage of energy intake | Approximately 7 days within 35-37 weeks gestation |
|
|
|
| Secondary | Percentage of Fat of Energy Intake | Percentage of fat of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation). | Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis) for various reasons. In the analyzed Arms, some participants were not analyzed as energy intake by remote food photography method was less than 60% of the total energy expenditure during that period. | Posted | Mean | Standard Deviation | percentage of energy intake | Approximately 7 days within 13-16 weeks gestation |
|
|
|
| Secondary | Percentage of Fat of Energy Intake | Percentage of fat of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation). | Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis) for various reasons. In the analyzed Arms, some participants were not analyzed as energy intake by remote food photography method was less than 60% of the total energy expenditure during that period. | Posted | Mean | Standard Deviation | percentage of energy intake | Approximately 7 days within 35-37 weeks gestation |
|
|
|
| Secondary | Percentage of Carbohydrate of Energy Intake | Percentage of carbohydrate of energy intake is determined by remote food photography method within early pregnancy (13-16 weeks gestation). | Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis) for various reasons. In the analyzed Arms, some participants were not analyzed as energy intake by remote food photography method was less than 60% of the total energy expenditure during that period. | Posted | Mean | Standard Deviation | percentage of energy intake | Approximately 7 days within 13-16 weeks gestation |
|
|
|
| Secondary | Percentage of Carbohydrate of Energy Intake | Percentage of carbohydrate of energy intake is determined by remote food photography method within late pregnancy (35-37 weeks gestation). | Analysis could not be completed for the Arm (Pregnant Women Not Included in Analysis) for various reasons. In the analyzed Arms, some participants were not analyzed as energy intake by remote food photography method was less than 60% of the total energy expenditure during that period. | Posted | Mean | Standard Deviation | percentage of energy intake | Approximately 7 days within 35-37 weeks gestation |
|
|
|
| 0 |
| 36 |
| 3 |
| 36 |
| 36 |
| 36 |
| EG001 | Pregnant Women With Recommended Gestational Weight Gain | Pregnant women with weight gain within the Institutes of Medicine gestational weight gain guidelines | 0 | 8 | 1 | 8 | 7 | 8 |
| EG002 | Pregnant Women With Inadequate Gestational Weight Gain | Pregnant women with weight gain below the Institutes of Medicine gestational weight gain guidelines | 0 | 10 | 0 | 10 | 9 | 10 |
| EG003 | Pregnant Women Not Included in Analysis | Pregnant women who enrolled in the study but were not included in data analysis for various reasons. | 0 | 18 | 4 | 18 | 15 | 18 |
| hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Hip pain requiring surgery |
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| Aphasia | Nervous system disorders | Systematic Assessment | Aphasia requiring overnight hospital stay |
|
| Kidney infection | Infections and infestations | Systematic Assessment | Kidney infection requiring hospital stay of 3 nights. |
|
| Vertigo | Nervous system disorders | Systematic Assessment | Vertigo requiring hospital stay. |
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| Pelvic infection | Infections and infestations | Systematic Assessment | Pelvic infection which caused preterm premature rupture of membranes and required a hospital stay. |
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| Headaches | Nervous system disorders | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Gestational Diabetes | Endocrine disorders | Systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Allergies | Immune system disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Abdominal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fungal Infection | Infections and infestations | Systematic Assessment |
|
| Bacterial Infection | Infections and infestations | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Body Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Stomach virus | Gastrointestinal disorders | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Fainting | Nervous system disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Carpal Tunnel | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pelvin Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hypotension | Cardiac disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Hip Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Folate Deficiency | Metabolism and nutrition disorders | Systematic Assessment |
|
| Irritable Bowel Syndrome | Gastrointestinal disorders | Systematic Assessment |
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| Oral Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Edema | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cystic Hygroma | Blood and lymphatic system disorders | Systematic Assessment |
|
| Protein Deficiency | Metabolism and nutrition disorders | Systematic Assessment |
|
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