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Completed

NCT Number: NCT03866902

Healthy Mothers-Healthy Children Nutrition

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.

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Key information

Age range

3 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for mothers will be:

  • age 18 years or older
  • self-identification as Hispanic
  • limited English proficiency; little acculturation, as measured by the Short Acculturation Scale for Hispanics with a score from 1.00 to 2.99
  • ability to understand spoken Spanish
  • a BMI >25kg/m^2
  • residence with the child
  • consent to join the study and consent for their child to join the study.

Inclusion criteria

for children will be:

  • age 3-5 years
  • ability to understand spoken Spanish
  • a BMI > 25th percentile for age and gender

Exclusion criteria

for mothers will be:

  • heart murmur
  • congenital heart disease
  • family history of sudden death
  • difficulty exercising
  • psychological problems

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Mother's Height From Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    Height in centimeters

  2. Change in Mother's Height From Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (approximately 15 months)

    Height in centimeters

  3. Change in Children's Height From Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    Height in centimeters

  4. Change in Children's Height From Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (approximately 15 months)

    Height in centimeters

  5. Change in Mother's Weight From Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    Weight in kilograms

  6. Change in Mother's Weight From Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (approximately 15 months)

    Weight in kilograms

  7. Change in Children's Weight From Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    Weight in kilograms

  8. Change in Children's Weight From Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (approximately 15 months)

    Weight in kilograms

  9. Change in Mother's BMI From Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    Calculation of BMI in Mothers in kilograms divided by meters squared

  10. Change in Mother's BMI From Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (approximately 15 months)

    Calculation of BMI in Mothers in kilograms divided by meters squared

  11. Change in Children's BMI Percentile From Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    Calculation of BMI measured in percentage in Children. Calculated by the percentage of the mean BMI.

  12. Change in Children's BMI Percentile From Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (approximately 15 months)

    Calculation of BMI Percentile in Children. Calculated by the percentage of the mean BMI.

  13. Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    Waist Circumference in centimeters

  14. Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (approximately 15 months)

    Waist Circumference in centimeters

  15. Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    Waist circumference in centimeters

  16. Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (approximately 15 months)

    Waist circumference in Centimeters

  17. Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    Triceps skinfolds in Millimeters

  18. Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (approximately 15 months)

    Triceps skinfolds in millimeters

  19. Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    Triceps skinfolds in millimeters

  20. Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (approximately 15 months)

    Triceps skinfolds in millimeters

  21. Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    Subscapular skinfolds in millimeters

  22. Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (approximately 15 months)

    Subscapular skinfolds in millimeters

  23. Change in Children's Adiposity (Subscapular Skinfolds) From Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    Subscapular skinfolds in millimeters

  24. Change in Children's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (approximately 15 months)

    Subscapular skinfolds in millimeters

Secondary outcomes

  1. Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    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.

  2. Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers From Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)

    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.

  3. Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Mothers From Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    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.

  4. Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Mothers From Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)

    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.

  5. Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children From Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    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.

  6. Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children From Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)

    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.

  7. Change in Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    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.

  8. Change in Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)

    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.

  9. Change in Exercise Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2

    Time frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)

    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.

  10. Change in Exercise Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 3

    Time frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)

    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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Healthy Mothers-Healthy Children: An Intervention With Hispanic Mothers and Their Young Children

Acronym: HMHC

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Mar 7, 2019
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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