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Family Partners for Health (WEIGHT)

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01378806
First received: June 2, 2011
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Overweight
Obesity
 Behavioral: Nutrition and exercise education and coping skills training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Children and Parents Partnering Together to Manage Their Weight

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change in body mass index in adults and body mass index percentile in children. [ Time Frame: Baseline to 18 months. ] [ Designated as safety issue: No ]
    Height and weight measures will be taken in adults and children to calculate body mass index in adults and body mass index percentile in children.


Secondary Outcome Measures:
  • Change in adiposity for adults and children as measured by change in waist circumference, triceps, and subscapular skinfold measures. [ Time Frame: Baseline to 18 months. ] [ Designated as safety issue: No ]
    Waist circumference and triceps and subscapular skinfold measures.

  • Change in health behaviors as measured by nutrition and exercise in adults and children. [ Time Frame: Baseline to 18 months. ] [ Designated as safety issue: No ]
    nutrition and exercise behaviors in adults and children based on questionnaire scores.

  • Change in self-efficacy in adults and children as measured by belief that they can improve their eating and exercise behaviors. [ Time Frame: Baseline to 18 months. ] [ Designated as safety issue: No ]
    eating and exercise self-efficacy in adults and children based on questionnaire scores.


Enrollment: 718
Study Start Date: April 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
A 12-week intensive intervention on nutrition and exercise education and coping skills training (Phase I), 9 months of continued monthly contact (Phase II), and then 6 months on their own.
 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.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Inclusion criteria for children include:

  • ability to speak, write, and read in English
  • a BMI > 85th percentile for age and gender
  • at least one parent or guardian with a BMI >25
  • assent and their parent or guardian's consent to their participation

Inclusion criteria for parents or guardians include:

  • ability to speak, write, and read in English
  • a BMI >25
  • a 2nd, 3rd or 4th grade child with a BMI > 85th percentile for age and gender
  • reside with the child; and consent to join the study

Exclusion Criteria: Parents and children will be excluded if either has a:

  • history of a heart murmur
  • congenital heart disease
  • family history of sudden death
  • history of psychological problems such as claustrophobia that would prevent participation in group classes
  • participation in another clinical trial or intervention
  • Asians will be excluded since there is a higher level of risk at a lower BMI than for Blacks, Hispanics, and Whites
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01378806

Locations
United States, North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7460
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Diane C Berry, PhD, ANP-BC University of North Carolina, Chapel Hill
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Diane Berry, PhD, ANP-BC/Associate Professor, The University of North Carolina at Chapel Hill
ClinicalTrials.gov Identifier: NCT01378806     History of Changes
Other Study ID Numbers: 07-0436, R0100254-05, 5-34696
Study First Received: June 2, 2011
Last Updated: July 12, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
overweight
obesity
adults
children

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013