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Family Partners for Health (WEIGHT)

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Overweight
Obesity

Treatments

Behavioral: Nutrition and exercise education and coping skills training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01378806
07-0436
5-34696 (Other Identifier)
R0100254-05 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

718 patients

Sex

All

Ages

7+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

718 participants in 1 patient group

Intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Nutrition and exercise education and coping skills training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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