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NCT01378806 · ClinicalTrials.gov registry record · NA
Family Partners for Health
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 718
- Enrollment target
NCT01378806 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 718 participants.
The verdict
NCT01378806, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 718 participants
- Enrollment target
Study 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 kg/m2 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 an
Interventions
- BEHAVIORAL Nutrition and exercise education and coping skills training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 718 participants |
| Start Date | 2007-04 |
| Est. Completion | 2011-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01378806
The ClinicalTrials.gov registry entry for NCT01378806 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 718 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nutrition and exercise education and coping skills training is the first listed.
NCT01378806 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01378806 about?
NCT01378806 is a clinical study titled "Family Partners for Health". 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 ...
What is the current status of trial NCT01378806?
This trial is currently completed. It is a NA study. The enrollment target is 718 participants. The study started on 2007-04. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01378806?
The interventions under investigation include: Nutrition and exercise education and coping skills training (BEHAVIORAL).
Who is sponsoring clinical trial NCT01378806?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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