HMHC: Healthy Mothers-Healthy Children Nutrition and Physical Activity Intervention

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03866902

Collaborator

National Institute of Nursing Research (NINR) (NIH)

584

Enrollment

Location

Arms

51.7

Anticipated Duration (Months)

11.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity Adiposity Nutrient; Excess Physical Activity	Behavioral: Nutrition and Physical Activity Intervention Other: English for Second Language Intervention	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

584 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two group randomized controlled repeated measures studyTwo group randomized controlled repeated measures study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 8, 2019

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Other: 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.

Active Comparator: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

Change in Mother's Height from Baseline (Time 1) to Time 2 [Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)]
Height in centimeters
Change in Mother's Height from Baseline (Time 1) to Time 3 [Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)]
Height in centimeters
Change in Children's Height from Baseline (Time 1) to Time 2 [Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)]
Height in centimeters
Change in Children's Height from Baseline (Time 1) to Time 3 [Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)]
Height in centimeters
Change in Mother's Weight from Baseline (Time 1) to Time 2 [Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)]
Weight in kilograms
Change in Mother's Weight from Baseline (Time 1) to Time 3 [Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)]
Weight in kilograms
Change in Children's Weight from Baseline (Time 1) to Time 2 [Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)]
Weight in kilograms
Change in Children's Weight from Baseline (Time 1) to Time 3 [Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)]
Weight in kilograms
Change in Mother's BMI from Baseline (Time 1) to Time 2 [Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)]
Calculation of BMI in Mothers in kilograms divided by meters squared
Change in Mother's BMI from Baseline (Time 1) to Time 3 [Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)]
Calculation of BMI in Mothers in kilograms divided by meters squared
Change in Children's BMI Percentile from Baseline (Time 1) to Time 2 [Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)]
Calculation of BMI Percentile in Children
Change in Children's BMI Percentile from Baseline (Time 1) to Time 3 [Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)]
Calculation of BMI Percentile in Children
Change in Mother's Adiposity (Waist Circumference) from Baseline (Time 1) to Time 2 [Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)]
Waist Circumference in centimeters
Change in Mother's Adiposity (Waist Circumference) from Baseline (Time 1) to Time 3 [Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)]
Waist Circumference in centimeters
Change in Children's Adiposity (Waist Circumference) from Baseline (Time 1) to Time 2 [Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)]
Waist circumference in centimeters
Change in Children's Adiposity (Waist Circumference) from Baseline (Time 1) to Time 3 [Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)]
Waist circumference in Centimeters
Change in Mother's Adiposity (Triceps Skinfold) from Baseline (Time 1) to Time 2 [Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)]
Triceps skinfolds in Millimeters
Change in Mother's Adiposity (Triceps Skinfold) from Baseline (Time 1) to Time 3 [Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)]
Triceps skinfolds in millimeters
Change in Children's Adiposity (Triceps Skinfold) from Baseline (Time 1) to Time 2 [Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)]
Triceps skinfolds in millimeters
Change in Children's Adiposity (Triceps Skinfold) from Baseline (Time 1) to Time 3 [Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)]
Triceps skinfolds in millimeters
Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 2 [Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)]
Subscapular skinfolds in millimeters
Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3 [Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)]
Subscapular skinfolds in millimeters
Change in Children's Adiposity (Subscapular Skinfolds) from Baseline (Time 1) to Time 2 [Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)]
Subscapular skinfolds in millimeters
Change in Children's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3 [Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)]
Subscapular skinfolds in millimeters

Secondary Outcome Measures

Change in Health Behaviors (Adult Health Behavior Questionnaire) in Mothers Baseline (Time 1) to Time 2 [Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)]
There are 23 questions with a range of answers for each question. Each question is scored individually as a predetermined healthy or unhealthy choice.
Change in Health Behaviors (Adult Health Behavior Questionnaire) in Mothers Baseline (Time 1) to Time 3 [Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)]
There are 23 questions with a range of answers for each question. Each question is scored individually as a predetermined healthy or unhealthy choice.
Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers Baseline (Time 1) to Time 2 [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.
Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers from Baseline (Time 1) to Time 3 [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.
Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Mothers from Baseline (Time 1) to Time 2 [Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)]
Phone Interview with the Mother on a Monday, Tuesday and Wednesday. The research assistant will ask the mother what she ate at breakfast, lunch, dinner and snacks and approximate amounts. This information will be entered into nutritionistpro a software program. Then total calories, protein, carbohydrate and fat can be calculated for each day.
Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Mothers from Baseline (Time 1) to Time 3 [Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)]
Phone Interview with the Mother on a Monday, Tuesday and Wednesday. The research assistant will ask the mother what she ate at breakfast, lunch, dinner and snacks and approximate amounts. This information will be entered into nutritionistpro a software program. Then total calories, protein, carbohydrate and fat can be calculated for each day.
Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Children from Baseline (Time 1) to Time 2 [Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)]
Phone Interview with the Mother on a Monday, Tuesday and Wednesday. The research assistant will ask the mother what her child ate at breakfast, lunch, dinner and snacks and approximate amounts. This information will be entered into nutritionistpro a software program. Then total calories, protein, carbohydrate and fat can be calculated for each day.
Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Children from Baseline (Time 1) to Time 3 [Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)]
Phone Interview with the Mother on a Monday, Tuesday and Wednesday. The research assistant will ask the mother what her child ate at breakfast, lunch, dinner and snacks and approximate amounts. This information will be entered into nutritionistpro a software program. Then total calories, protein, carbohydrate and fat can be calculated for each day.
Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Mothers from Baseline (Time 1) to Time 2 [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.
Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Mothers from Baseline (Time 1) to Time 3 [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.
Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children from Baseline (Time 1) to Time 2 [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.
Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children from Baseline (Time 1) to Time 3 [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.
Change in Eating Self-Efficacy Questionnaire in Mothers from Baseline (Time 1) to Time 2 [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.
Change in Eating Self-Efficacy Questionnaire in Mothers from Baseline (Time 1) to Time 3 [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.
Change in Exercise Self-Efficacy Questionnaire in Mothers from Baseline (Time 1) to Time 2 [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.
Change in Exercise Self-Efficacy Questionnaire in Mothers from Baseline (Time 1) to Time 3 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.