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OpenTrials
Completed

NCT Number: NCT01378806

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 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.

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Key information

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7460, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition and exercise education and coping skills training

Behavioral

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.

Primary outcomes

  1. Change in body mass index in adults and body mass index percentile in children.

    Time frame: Baseline to 18 months.

    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 outcomes

  1. 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.

    Waist circumference and triceps and subscapular skinfold measures.

  2. Change in health behaviors as measured by nutrition and exercise in adults and children.

    Time frame: Baseline to 18 months.

    nutrition and exercise behaviors in adults and children based on questionnaire scores.

  3. 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.

    eating and exercise self-efficacy in adults and children based on questionnaire scores.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • National Institutes of Health (NIH)

Registry information

Official study title

Children and Parents Partnering Together to Manage Their Weight

Acronym: WEIGHT

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jun 22, 2011
Registry last updated
Jul 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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