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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR017199-01 | U.S. NIH Grant/Contract | View source | |
| 17-0979 | Other Identifier | UNC Chapel Hill |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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Using a randomized two-group, repeated measures experimental design, the goal of the proposed study is to investigate the efficacy of a 12-week nutrition and exercise education, physical activity, coping skills training, and home-based physical activity intervention in Hispanic women and their 3-5 year old children and 6 months of continued monthly contact to help overweight and obese Hispanic mothers improve adiposity, weight, health behaviors, and self-efficacy and their 3-5 year old children improve their adiposity and weight gain trajectory and health behaviors.
Hispanic women and children who become overweight or obese are at risk for developing prediabetes, type 2 diabetes, and cardiovascular disease later in life. To date, there have been no interdisciplinary interventions that have targeted Hispanic women and their 3-5 year old children to improve nutrition and physical activity behaviors to manage adiposity and weight in mothers and prevent excessive adiposity and weight gain trajectory in their children. Using a randomized two-group, repeated measures experimental design, the goal of the proposed study is to investigate the efficacy of a 12-week nutrition and exercise education, physical activity, coping skills training, and home-based physical activity intervention in Hispanic women and their 3-5 year old children and 6 months of continued monthly contact to help overweight and obese Hispanic mothers improve adiposity, weight, health behaviors (nutrition and physical activity), and self-efficacy and their 3-5 year old children improve their adiposity and weight gain trajectory and health behaviors (nutrition and physical activity). The investigators will partner with two federally qualified health departments in Durham and Chatham, North Carolina to enroll Hispanic women and their 3-5 year old children and the investigators will partner with community centers to deliver the intervention. A total of 294 Hispanic women with a BMI >25 kg/m² and 294 Hispanic 3-5 year old children with a BMI percentile > 25 will be enrolled over 4 years and randomized to the experimental or equal attention control group. Data will be collected at Time 1 (0 months [baseline]) to Time 2 (9 months [completion of the intervention]) and Time 1 to Time 3 (15 months [after 6 months with no contact from the study staff]). Data collected will include adiposity (primary outcomes: waist circumference, triceps and subscapular skinfolds) in mothers and children and weight (primary outcomes: body mass index [BMI] in mothers and BMI percentile in the children). Secondary outcomes will include health behaviors and self-efficacy in the mothers (Adult Health Behavior Questionnaire, Lifestyle Health Promoting Profile II, 3 day 24-Hour Food Recall, and 7 day Accelerometer, Eating Self-Efficacy Scale and Exercise Self-Efficacy Scale) and in the children (7 day Accelerometer and 3 day 24-Hour Food Recall). The investigators will also evaluate the cost of delivering the program for public health departments. Data analysis will use general linear mixed models to test the hypotheses. Decreasing overweight and obesity in Hispanic women and slowing adiposity and weight gain trajectory in young Hispanic children is urgently needed to decrease morbidity, mortality, and future health care costs. The knowledge to be gained from this study may provide a foundation for extending this intervention to other Hispanic mothers and children in other communities to assist mothers in managing their weight and preventing excessive adiposity and weight gain in their children. This approach is translatable, real-world, and could be replicated in other areas of the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition and Physical Activity Intervention | Experimental | Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months. Classes for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months. |
|
| English for Second Language Intervention | Active Comparator | Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months. Children in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition and Physical Activity Intervention | Behavioral | Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class. Children. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mother's Height From Baseline (Time 1) to Time 2 | Height in centimeters | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Mother's Height From Baseline (Time 1) to Time 3 | Height in centimeters | Baseline (Time 1), Time 3 (approximately 15 months) |
| Change in Children's Height From Baseline (Time 1) to Time 2 | Height in centimeters | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Children's Height From Baseline (Time 1) to Time 3 | Height in centimeters | Baseline (Time 1), Time 3 (approximately 15 months) |
| Change in Mother's Weight From Baseline (Time 1) to Time 2 | Weight in kilograms | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Mother's Weight From Baseline (Time 1) to Time 3 | Weight in kilograms | Baseline (Time 1), Time 3 (approximately 15 months) |
| Change in Children's Weight From Baseline (Time 1) to Time 2 | Weight in kilograms | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Children's Weight From Baseline (Time 1) to Time 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers Baseline (Time 1) to Time 2 | There are 34 questions and the answer choices are never, sometime, often or routinely. Never is scored a 0, sometimes is scored a 1, often is scored a 2 and routine is scored a 3. The 34 questions are summed to provide a total score. A higher score reflects healthier behaviors and a lower score reflects unhealthier behaviors. |
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Inclusion criteria for mothers will be:
Inclusion criteria for children will be:
Exclusion criteria for mothers will be:
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| Name | Affiliation | Role |
|---|---|---|
| Hudson Santos, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32153971 | Derived | Berry DC, Gonzales C, Montano NP, Perreira KM, Ammerman AS, Crandell J, Evenson KR, Faith MS, Waters H, Linares C, Comicronrtes YI, Perrin EM. Rationale, design, and methodology for the healthy mothers-healthy children study: a randomized controlled trial. BMC Nutr. 2019 Dec 16;5:58. doi: 10.1186/s40795-019-0322-7. eCollection 2019. |
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Dyad study design. Only one consent was signed by mother to agree to both mother and child to participant in the study; therefore, a total of 578 were enrolled in the study. 4 signed the consent but were not randomized into the groups for this study and did not participate in the intervention because of a lack of desire to participate just prior to the intervention starting; therefore, were not enrolled in the arms. Mother/child dyads that went into the arms/groups Total= 574.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nutrition and Physical Activity Intervention | Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months. Classes for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months. Nutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class. Children. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play. |
| FG001 | English for Second Language Intervention | Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months. Children in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months. English for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material. Children. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This is a dyad study. Data was collected for both mother and child for the gender and age category. Ethnicity was only collected for mother.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nutrition and Physical Activity Intervention | Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months. Classes for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months. Nutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class. Children. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One of the mother's data for age was not collected. |
| 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 | Change in Mother's Height From Baseline (Time 1) to Time 2 | Height in centimeters | Posted | Mean | Standard Deviation | Centimeters | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
|
15 months
Both the mother and child were monitored for 4 years for the duration over which adverse events were monitored/assessed
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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 | Nutrition and Physical Activity Intervention-Mother | Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hudson Santos | University of Miami | 3052845812 | hsantos@miami.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 | Jun 19, 2019 | Mar 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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Two group randomized controlled repeated measures study
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The statistician has created a randomization table in RedCap. After enrollment and baseline assessment, dyads will be randomized to either the intervention or control group using a computer-generated randomization table, stratifying by BMI group, overweight (25 - 29.9 kg/m²) and obese (>30 kg/m²), and utilizing blocking to help ensure balance between the groups. Mothers will be informed of their group assignment by telephone.
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| English for Second Language Intervention | Other | Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material. Children. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons. |
Weight in kilograms |
| Baseline (Time 1), Time 3 (approximately 15 months) |
| Change in Mother's BMI From Baseline (Time 1) to Time 2 | Calculation of BMI in Mothers in kilograms divided by meters squared | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Mother's BMI From Baseline (Time 1) to Time 3 | Calculation of BMI in Mothers in kilograms divided by meters squared | Baseline (Time 1), Time 3 (approximately 15 months) |
| Change in Children's BMI Percentile From Baseline (Time 1) to Time 2 | Calculation of BMI measured in percentage in Children. Calculated by the percentage of the mean BMI. | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Children's BMI Percentile From Baseline (Time 1) to Time 3 | Calculation of BMI Percentile in Children. Calculated by the percentage of the mean BMI. | Baseline (Time 1), Time 3 (approximately 15 months) |
| Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2 | Waist Circumference in centimeters | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3 | Waist Circumference in centimeters | Baseline (Time 1), Time 3 (approximately 15 months) |
| Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2 | Waist circumference in centimeters | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3 | Waist circumference in Centimeters | Baseline (Time 1), Time 3 (approximately 15 months) |
| Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2 | Triceps skinfolds in Millimeters | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3 | Triceps skinfolds in millimeters | Baseline (Time 1), Time 3 (approximately 15 months) |
| Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2 | Triceps skinfolds in millimeters | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3 | Triceps skinfolds in millimeters | Baseline (Time 1), Time 3 (approximately 15 months) |
| Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 2 | Subscapular skinfolds in millimeters | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3 | Subscapular skinfolds in millimeters | Baseline (Time 1), Time 3 (approximately 15 months) |
| Change in Children's Adiposity (Subscapular Skinfolds) From Baseline (Time 1) to Time 2 | Subscapular skinfolds in millimeters | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Children's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3 | Subscapular skinfolds in millimeters | Baseline (Time 1), Time 3 (approximately 15 months) |
| Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers From Baseline (Time 1) to Time 3 | There are 34 questions and the answer choices are never, sometime, often or routinely. Never is scored a 0, sometimes is scored a 1, often is scored a 2 and routine is scored a 3. The 34 questions are summed to provide a total score. A higher score reflects healthier behaviors and a lower score reflects unhealthier behaviors. | Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months) |
| Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Mothers From Baseline (Time 1) to Time 2 | The Mother will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity. | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Mothers From Baseline (Time 1) to Time 3 | The Mother will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity. | Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months) |
| Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children From Baseline (Time 1) to Time 2 | The Child will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity. | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children From Baseline (Time 1) to Time 3 | The Child will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity. | Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months) |
| Change in Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2 | This is a 25 question questionnaire asking how much difficulty the Mother has with controlling her eating in social situations and everyday. The range of scores go from 1 to 7 with 1 being no difficulty controlling eating to 4 moderate difficulty controlling eating to 7 the most difficulty controlling eating. The 25 questions are added to produce a total score. A lower score equals less difficulty controlling eating and a higher score equals more difficulty controlling eating. | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 3 | This is a 25 question questionnaire asking how much difficulty the Mother has with controlling her eating in social situations and everyday. The range of scores go from 1 to 7 with 1 being no difficulty controlling eating to 4 moderate difficulty controlling eating to 7 the most difficulty controlling eating. The 25 questions are added to produce a total score. A lower score equals less difficulty controlling eating and a higher score equals more difficulty controlling eating. | Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months) |
| Change in Exercise Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2 | This is a 18 question questionnaire asking how much difficulty the Mother has with exercise. The range of scores go from 1 to 10 with 1 being she can not do it at all and 6 that she can moderately do exercise and a 10 that she is certain she can do it. The numbers are summed for a total score. A lower number indicates that the mother has a lot of difficulty exercising and a higher number means that the mother is more certain she can exercise. | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
| Change in Exercise Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 3 | This is a 18 question questionnaire asking how much difficulty the Mother has with exercise. The range of scores go from 1 to 10 with 1 being she can not do it at all and 6 that she can moderately do exercise and a 10 that she is certain she can do it. The numbers are summed for a total score. A lower number indicates that the mother has a lot of difficulty exercising and a higher number means that the mother is more certain she can exercise. | Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months) |
| BG001 | English for Second Language Intervention | Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months. Children in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months. English for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material. Children. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | One of the child's data for the sex was not collected. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Only data for the mother was collected. | Count of Participants | Participants |
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| OG001 | English for Second Language Intervention | Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months. Children in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months. English for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material. Children. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons. |
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| Primary | Change in Mother's Height From Baseline (Time 1) to Time 3 | Height in centimeters | Posted | Mean | Standard Deviation | Centimeters | Baseline (Time 1), Time 3 (approximately 15 months) |
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| Primary | Change in Children's Height From Baseline (Time 1) to Time 2 | Height in centimeters | Posted | Mean | Standard Deviation | Centimeters | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
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| Primary | Change in Children's Height From Baseline (Time 1) to Time 3 | Height in centimeters | Posted | Mean | Standard Deviation | Centimeters | Baseline (Time 1), Time 3 (approximately 15 months) |
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| Primary | Change in Mother's Weight From Baseline (Time 1) to Time 2 | Weight in kilograms | Posted | Mean | Standard Deviation | Kilograms | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
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| Primary | Change in Mother's Weight From Baseline (Time 1) to Time 3 | Weight in kilograms | Posted | Mean | Standard Deviation | Kilograms | Baseline (Time 1), Time 3 (approximately 15 months) |
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| Primary | Change in Children's Weight From Baseline (Time 1) to Time 2 | Weight in kilograms | Posted | Mean | Standard Deviation | Kilograms | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
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| Primary | Change in Children's Weight From Baseline (Time 1) to Time 3 | Weight in kilograms | Posted | Mean | Standard Deviation | Kilograms | Baseline (Time 1), Time 3 (approximately 15 months) |
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| Primary | Change in Mother's BMI From Baseline (Time 1) to Time 2 | Calculation of BMI in Mothers in kilograms divided by meters squared | Posted | Mean | Standard Deviation | kg/m^2 | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
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| Primary | Change in Mother's BMI From Baseline (Time 1) to Time 3 | Calculation of BMI in Mothers in kilograms divided by meters squared | Posted | Mean | Standard Deviation | kg/m^2 | Baseline (Time 1), Time 3 (approximately 15 months) |
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| Primary | Change in Children's BMI Percentile From Baseline (Time 1) to Time 2 | Calculation of BMI measured in percentage in Children. Calculated by the percentage of the mean BMI. | Posted | Mean | Standard Deviation | percentage of children's BMI | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
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| Primary | Change in Children's BMI Percentile From Baseline (Time 1) to Time 3 | Calculation of BMI Percentile in Children. Calculated by the percentage of the mean BMI. | Posted | Mean | Standard Deviation | percentage of children's BMI | Baseline (Time 1), Time 3 (approximately 15 months) |
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| Primary | Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2 | Waist Circumference in centimeters | Posted | Mean | Standard Deviation | Centimeters | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
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| Primary | Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3 | Waist Circumference in centimeters | Posted | Mean | Standard Deviation | Centimeters | Baseline (Time 1), Time 3 (approximately 15 months) |
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| Primary | Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2 | Waist circumference in centimeters | Posted | Mean | Standard Deviation | Centimeters | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
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| Primary | Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3 | Waist circumference in Centimeters | Posted | Mean | Standard Deviation | Centimeters | Baseline (Time 1), Time 3 (approximately 15 months) |
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| Primary | Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2 | Triceps skinfolds in Millimeters | Posted | Mean | Standard Deviation | Millimeters | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
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| Primary | Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3 | Triceps skinfolds in millimeters | Posted | Mean | Standard Deviation | Millimeters | Baseline (Time 1), Time 3 (approximately 15 months) |
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| Primary | Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2 | Triceps skinfolds in millimeters | Posted | Mean | Standard Deviation | Millimeters | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
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| Primary | Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3 | Triceps skinfolds in millimeters | Posted | Mean | Standard Deviation | Millimeters | Baseline (Time 1), Time 3 (approximately 15 months) |
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| Primary | Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 2 | Subscapular skinfolds in millimeters | Posted | Mean | Standard Deviation | Millimeters | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
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| Primary | Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3 | Subscapular skinfolds in millimeters | Posted | Mean | Standard Deviation | Millimeters | Baseline (Time 1), Time 3 (approximately 15 months) |
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| Primary | Change in Children's Adiposity (Subscapular Skinfolds) From Baseline (Time 1) to Time 2 | Subscapular skinfolds in millimeters | Posted | Mean | Standard Deviation | Millimeters | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
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| Primary | Change in Children's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3 | Subscapular skinfolds in millimeters | Posted | Mean | Standard Deviation | Millimeters | Baseline (Time 1), Time 3 (approximately 15 months) |
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| Secondary | Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers Baseline (Time 1) to Time 2 | There are 34 questions and the answer choices are never, sometime, often or routinely. Never is scored a 0, sometimes is scored a 1, often is scored a 2 and routine is scored a 3. The 34 questions are summed to provide a total score. A higher score reflects healthier behaviors and a lower score reflects unhealthier behaviors. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
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| Secondary | Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers From Baseline (Time 1) to Time 3 | There are 34 questions and the answer choices are never, sometime, often or routinely. Never is scored a 0, sometimes is scored a 1, often is scored a 2 and routine is scored a 3. The 34 questions are summed to provide a total score. A higher score reflects healthier behaviors and a lower score reflects unhealthier behaviors. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months) |
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| Secondary | Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Mothers From Baseline (Time 1) to Time 2 | The Mother will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity. | Posted | Mean | Standard Deviation | steps | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
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| Secondary | Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Mothers From Baseline (Time 1) to Time 3 | The Mother will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity. | Posted | Mean | Standard Deviation | steps | Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months) |
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| Secondary | Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children From Baseline (Time 1) to Time 2 | The Child will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity. | Posted | Mean | Standard Deviation | steps | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
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| Secondary | Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children From Baseline (Time 1) to Time 3 | The Child will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity. | Posted | Mean | Standard Deviation | steps | Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months) |
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| Secondary | Change in Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2 | This is a 25 question questionnaire asking how much difficulty the Mother has with controlling her eating in social situations and everyday. The range of scores go from 1 to 7 with 1 being no difficulty controlling eating to 4 moderate difficulty controlling eating to 7 the most difficulty controlling eating. The 25 questions are added to produce a total score. A lower score equals less difficulty controlling eating and a higher score equals more difficulty controlling eating. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
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| Secondary | Change in Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 3 | This is a 25 question questionnaire asking how much difficulty the Mother has with controlling her eating in social situations and everyday. The range of scores go from 1 to 7 with 1 being no difficulty controlling eating to 4 moderate difficulty controlling eating to 7 the most difficulty controlling eating. The 25 questions are added to produce a total score. A lower score equals less difficulty controlling eating and a higher score equals more difficulty controlling eating. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months) |
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| Secondary | Change in Exercise Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2 | This is a 18 question questionnaire asking how much difficulty the Mother has with exercise. The range of scores go from 1 to 10 with 1 being she can not do it at all and 6 that she can moderately do exercise and a 10 that she is certain she can do it. The numbers are summed for a total score. A lower number indicates that the mother has a lot of difficulty exercising and a higher number means that the mother is more certain she can exercise. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months) |
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| Secondary | Change in Exercise Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 3 | This is a 18 question questionnaire asking how much difficulty the Mother has with exercise. The range of scores go from 1 to 10 with 1 being she can not do it at all and 6 that she can moderately do exercise and a 10 that she is certain she can do it. The numbers are summed for a total score. A lower number indicates that the mother has a lot of difficulty exercising and a higher number means that the mother is more certain she can exercise. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months) |
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| 0 |
| 144 |
| 0 |
| 144 |
| 0 |
| 144 |
| EG001 | English for Second Language Intervention-Mother | Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months. | 0 | 143 | 0 | 143 | 0 | 143 |
| EG002 | Nutrition and Physical Activity Intervention-Child | Classes for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months. | 0 | 144 | 0 | 144 | 0 | 144 |
| EG003 | English for Second Language Intervention-Child | Children in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months. | 0 | 143 | 0 | 143 | 0 | 143 |
Not provided
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D003710 | Demography |
| D011154 | Population Characteristics |
| Male |
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| Unknown or Not Reported |
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