Family Partners for Health (WEIGHT)
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition and exercise education and coping skills training
Sponsored by

About this trial
This is an interventional treatment trial for Overweight focused on measuring overweight, obesity, adults, children
Eligibility 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
Sites / Locations
- The University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT01378806
First Posted
June 2, 2011
Last Updated
July 12, 2012
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT01378806
Brief Title
Family Partners for Health
Acronym
WEIGHT
Official Title
Children and Parents Partnering Together to Manage Their Weight
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
overweight, obesity, adults, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
718 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition and exercise education and coping skills training
Intervention Description
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 Outcome Measure Information:
Title
Change in body mass index in adults and body mass index percentile in children.
Description
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.
Time Frame
Baseline to 18 months.
Secondary Outcome Measure Information:
Title
Change in adiposity for adults and children as measured by change in waist circumference, triceps, and subscapular skinfold measures.
Description
Waist circumference and triceps and subscapular skinfold measures.
Time Frame
Baseline to 18 months.
Title
Change in health behaviors as measured by nutrition and exercise in adults and children.
Description
nutrition and exercise behaviors in adults and children based on questionnaire scores.
Time Frame
Baseline to 18 months.
Title
Change in self-efficacy in adults and children as measured by belief that they can improve their eating and exercise behaviors.
Description
eating and exercise self-efficacy in adults and children based on questionnaire scores.
Time Frame
Baseline to 18 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane C Berry, PhD, ANP-BC
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7460
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30200925
Citation
Berry DC, McMurray RG, Schwartz TA, Adatorwovor R. Benefits for African American and white low-income 7-10-year-old children and their parents taught together in a community-based weight management program in the rural southeastern United States. BMC Public Health. 2018 Sep 10;18(1):1107. doi: 10.1186/s12889-018-6006-4.
Results Reference
derived
PubMed Identifier
29225899
Citation
Berry DC, McMurray RG, Schwartz TA, Hall EG, Neal MN, Adatorwovor R, Adatorwover R. A cluster randomized controlled trial for child and parent weight management: children and parents randomized to the intervention group have correlated changes in adiposity. BMC Obes. 2017 Dec 4;4:39. doi: 10.1186/s40608-017-0175-z. eCollection 2017. Erratum In: BMC Obes. 2018 Jan 26;5:3. Adatorwover R [corrected to Adatorwovor R].
Results Reference
derived
PubMed Identifier
26851940
Citation
McMurray RG, Berry DC, Schwartz TA, Hall EG, Neal MN, Li S, Lam D. Relationships of physical activity and sedentary time in obese parent-child dyads: a cross-sectional study. BMC Public Health. 2016 Feb 6;16:124. doi: 10.1186/s12889-016-2795-5.
Results Reference
derived
PubMed Identifier
22463125
Citation
Berry DC, McMurray R, Schwartz TA, Skelly A, Sanchez M, Neal M, Hall G. Rationale, design, methodology and sample characteristics for the family partners for health study: a cluster randomized controlled study. BMC Public Health. 2012 Mar 30;12:250. doi: 10.1186/1471-2458-12-250.
Results Reference
derived
Learn more about this trial
Family Partners for Health
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