Family Partners for Health

NCT ID: NCT01378806

Last Updated: 2012-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 718 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2011-10-31

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.

Conditions

Overweight; Obesity

Keywords

overweight; obesity; adults; children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nutrition and exercise education and coping skills training

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

The University of North Carolina at Chapel Hill

Principal Investigators

Diane C Berry, PhD, ANP-BC

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30200925 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29225899 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26851940 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22463125 (View on PubMed)

Other Identifiers

R0100254-05

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

5-34696

Identifier Type: OTHER

Identifier Source: secondary_id

07-0436

Identifier Type: -

Identifier Source: org_study_id