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Family Partners for Health (WEIGHT)

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ClinicalTrials.gov Identifier: NCT01378806
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : July 13, 2012
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Information provided by:
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE June 2, 2011
First Posted Date  ICMJE June 22, 2011
Last Update Posted Date July 13, 2012
Study Start Date  ICMJE April 2007
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01378806 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2011)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Family Partners for Health
Official Title  ICMJE Children and Parents Partnering Together to Manage Their Weight
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight
  • Obesity
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Nutrition and exercise education and coping skills training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2011)
718
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01378806
Other Study ID Numbers  ICMJE 07-0436
R0100254-05 ( Other Grant/Funding Number: NINR )
5-34696 ( Other Identifier: The University of North Carolina at Chapel )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Diane Berry, PhD, ANP-BC/Associate Professor, The University of North Carolina at Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Diane C Berry, PhD, ANP-BC University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP