Ignite Creation Date:
2024-05-06 @ 12:52 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03866902
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2019-02-24
Brief Title:
Healthy Mothers-Healthy Children Nutrition
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Healthy Mothers-Healthy Children An Intervention With Hispanic Mothers and Their Young Children
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HMHC
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 kgm² 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 17-0979 | OTHER | UNC Chapel Hill | httpsreporternihgovquickSearch1R01NR017199-01 |
| 1R01NR017199-01 | NIH | None | None |