Healthy Mothers-Healthy Children Nutrition

Physical Activity Clinical Trial

— HMHC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03866902
• Other study ID #: 20220623
• Secondary ID: 1R01NR017199-011
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 8, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 588
• Est. completion date: June 30, 2024
• Est. primary completion date: April 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Adiposity
• Nutrient; Excess
• Obesity
• Overweight
• Overweight and Obesity
• Physical Activity

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Change in Mother's Height from Baseline (Time 1) to Time 3	Height in centimeters	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
Primary	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)
Primary	Change in Children's Height from Baseline (Time 1) to Time 3	Height in centimeters	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
Primary	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)
Primary	Change in Mother's Weight from Baseline (Time 1) to Time 3	Weight in kilograms	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
Primary	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)
Primary	Change in Children's Weight from Baseline (Time 1) to Time 3	Weight in kilograms	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
Primary	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)
Primary	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 (after 6 months with no contact from the study staff, approximately 15 months)
Primary	Change in Children's BMI Percentile from Baseline (Time 1) to Time 2	Calculation of BMI Percentile in Children	Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
Primary	Change in Children's BMI Percentile from Baseline (Time 1) to Time 3	Calculation of BMI Percentile in Children	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
Primary	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)
Primary	Change in Mother's Adiposity (Waist Circumference) from Baseline (Time 1) to Time 3	Waist Circumference in centimeters	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
Primary	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)
Primary	Change in Children's Adiposity (Waist Circumference) from Baseline (Time 1) to Time 3	Waist circumference in Centimeters	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
Primary	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)
Primary	Change in Mother's Adiposity (Triceps Skinfold) from Baseline (Time 1) to Time 3	Triceps skinfolds in millimeters	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
Primary	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)
Primary	Change in Children's Adiposity (Triceps Skinfold) from Baseline (Time 1) to Time 3	Triceps skinfolds in millimeters	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
Primary	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)
Primary	Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3	Subscapular skinfolds in millimeters	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
Primary	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)
Primary	Change in Children's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3	Subscapular skinfolds in millimeters	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
Secondary	Change in Health Behaviors (Adult Health Behavior Questionnaire) in Mothers Baseline (Time 1) to Time 2	There are 23 questions with a range of answers for each question. Each question is scored individually as a predetermined healthy or unhealthy choice.	Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
Secondary	Change in Health Behaviors (Adult Health Behavior Questionnaire) in Mothers Baseline (Time 1) to Time 3	There are 23 questions with a range of answers for each question. Each question is scored individually as a predetermined healthy or unhealthy choice.	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
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.	Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
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.	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
Secondary	Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Mothers from Baseline (Time 1) to Time 2	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.	Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
Secondary	Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Mothers from Baseline (Time 1) to Time 3	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.	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
Secondary	Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Children from Baseline (Time 1) to Time 2	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.	Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
Secondary	Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Children from Baseline (Time 1) to Time 3	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.	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
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.	Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
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.	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
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.	Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
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.	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
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.	Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
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.	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)
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.	Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)
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.	Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)