Family Partners for Health

NCT01378806 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 718

Last updated 2012-07-13

No results posted yet for this 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 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.

Conditions

Interventions

BEHAVIORAL

Nutrition and exercise education and coping skills training

A 12-week intensive intervention on nutrition and exercise education and coping skills (Phase I), 9 months of continued monthly contact (Phase II), and then 6 months on their own.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • National Institute of Nursing Research (NINR)

    collaborator NIH
  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Diane C Berry, PhD, ANP-BC · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01378806 on ClinicalTrials.gov