Viewing Study NCT01378806



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Last Modification Date: 2024-10-26 @ 10:37 AM
Study NCT ID: NCT01378806
Status: COMPLETED
Last Update Posted: 2012-07-13
First Post: 2011-06-02

Brief Title: Family Partners for Health
Sponsor: University of North Carolina Chapel Hill
Organization: University of North Carolina Chapel Hill

Study Overview

Official Title: Children and Parents Partnering Together to Manage Their Weight
Status: COMPLETED
Status Verified Date: 2012-07
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: WEIGHT
Brief Summary: Young children who are overweight or at risk for overweight are at increased risk for becoming obese as young adults and developing type 2 diabetes and cardiovascular disease To date there have been no interdisciplinary interventions that targeted predominantly ethnic minority low-income children and parents and taught them to work together to improve nutrition and exercise Using a two-group repeated measures experimental design this proposed study will test a 12-week intensive intervention on nutrition exercise and coping skills Phase I and 9 months of continued monthly contact Phase II to help overweight 2nd 3rd and 4th grade children and their parents improve self-efficacy health behaviors weight status and adiposity The study will take this intervention to the community in which children and parents live working with four schools in Alamance-Burlington County NC and four schools in Wilson County in the early evening A total of 356 Black Hispanic and White children with a BMI 85th percentile and 356 parents with a BMI 25 kgm2 will be inducted over 3 ½ years and randomized by school to either the experimental or control group Data will be collected at Time 1 Baseline Time 2 Post Phase I-Intensive Intervention Time 3 Post Phase II-Continued Contact and Time 4 6-Month Follow-Up Data collected will include scores on the Health Promoting Lifestyle Profile II in the parents eating self-efficacy in the children CATCH and parents Eating Self-Efficacy Scale and exercise self-efficacy in the children CATCH and parents Exercise Self-Efficacy health behaviors in the children and parents 3 Day 24-Hour Food Recall and 4 Day Accelerometry Measurement weight status in the children BMI percentile and parents BMI and adiposity in the children and parents waist circumference and triceps and subscapular skinfolds Data analysis will use general linear mixed models to test the hypotheses Decreasing overweight in children and parents is urgently needed and helping children and parents to work together to improve their nutrition and exercise patterns by making small lifestyle pattern changes may decrease future health care costs and decrease morbidity and mortality The knowledge to be gained from this study may provide a foundation for extending this intervention to other Black Hispanic and White children and parents in other communities to assist them to manage their weight
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
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
5-34696 OTHER The University of North Carolina at Chapel None
R0100254-05 OTHER_GRANT None None