Family Partners for Health

Obesity Clinical Trial

— WEIGHT  

Official title:

Children and Parents Partnering Together to Manage Their Weight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01378806
• Other study ID #: 07-0436
• Secondary ID: R0100254-055-346
• Status: Completed
• Phase: N/A
• First received: June 2, 2011
• Last updated: July 12, 2012
• Start date: April 2007
• Est. completion date: October 2011

Study information

• Verified date: July 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 718
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body mass index in adults and body mass index percentile in children.	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.	Baseline to 18 months.	No
Secondary	Change in adiposity for adults and children as measured by change in waist circumference, triceps, and subscapular skinfold measures.	Waist circumference and triceps and subscapular skinfold measures.	Baseline to 18 months.	No
Secondary	Change in health behaviors as measured by nutrition and exercise in adults and children.	nutrition and exercise behaviors in adults and children based on questionnaire scores.	Baseline to 18 months.	No
Secondary	Change in self-efficacy in adults and children as measured by belief that they can improve their eating and exercise behaviors.	eating and exercise self-efficacy in adults and children based on questionnaire scores.	Baseline to 18 months.	No