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Clinical Trials/NCT03866902
NCT03866902
Completed
N/A

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

University of Miami1 site in 1 country578 target enrollmentFebruary 8, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Overweight and Obesity
Sponsor
University of Miami
Enrollment
578
Locations
1
Primary Endpoint
Change in Children's Weight From Baseline (Time 1) to Time 2
Status
Completed
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
February 8, 2019
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hudson Santos

Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

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

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

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.

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))

Study Sites (1)

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