Church, Extension and Academic Partners Empowering Healthy Families — EHF  

Obesity Clinical Trial

Official title: Church, Extension and Academic Partners Empowering Healthy Families

Status Terminated

Clinical Trial Summary

The project will address health disparities via a community-engaged approach in partnership with black churches. The long-term goals of this integrated project are to: 1) prevent and reduce childhood obesity through improved parenting practices and home environment related to obesity; 2) expand Extension capacity for community-engaged research and collaborative programming with faith-based organizations; 3) enhance Extension strategies for recruiting and training community volunteers to extend Extension reach; and 4) train future health professionals to provide culturally appropriate collaborative community-based health programs. The project will target the school-aged subset (ages 6-11, first through fifth grade) of the USDA target age range of ages 2-19. The 14-month randomized control trial design of the research component will generate new knowledge regarding effectiveness of a integrated family-based intervention enhanced with social and environmental (church) support to prevent obesity in school-aged children. The research design with a financial literacy active control condition and the primary nutrition and physical activity intervention being tested meets two needs expressed by the community partner and allows rigorous evaluation of both Extension programs. It is hypothesized that parents in the intervention group will have higher levels of self-efficacy for obesity-prevention behaviors, parenting practices related to food and physical activity, improved home food and physical activity. The long term impact is to reduce the prevalence of childhood obesity.

Clinical Trial Description

The study follows a group-randomized design. Twenty-four churches will participate based on feasibility and logistical considerations demonstrated in previous work. Church leaders will agree to host the program, identify a church program coordinator to recruit participants and facilitate project implementation, and identify at least two volunteers willing to be trained to deliver the child curricula. Each church will be randomly assigned to treatment condition (HCHF+) or Money-Smart (active control) after baseline data collection. Churches will advertise the Empowering Healthy Families program to church members and to the community at large. The church coordinator will determine the most effective venues and strategies for advertising the program.

Each church will be randomly assigned to one of two treatment conditions: 1) lifestyle and parenting intervention for parents with a complementary age-appropriate lifestyle curriculum for children and strategies to improve the church health environment (HCHF+); or 2) financial literacy curricula (Money Smart) for parents and children (active control). Randomization at the level of church takes advantage of social networking within churches. Consistent with preliminary research, Social Cognitive Theory (SCT), Social-Ecological Model (SEM) and principles of Community based participatory research (CBPR) and community engagement will guide the intervention research and will be reflected in all formative, process and outcome data collection and analyses. Key stakeholders will be involved in all aspects of the research.

Partners include current partners Baptist General Convention of Virginia (BGCVA), Virginia Cooperative Extension's (VCE) Family and Consumer Sciences (FCS) Program at Virginia Tech (VT) and Virginia State University (VSU, historically black state university), Virginia Tech's Center for Public Health Practice and Research (CPHPR) as well as new partners, the Family Nutrition Program (FNP) and 4-H Program at VT and VSU. Partner and Community Involvement in Project Partners and members of the target communities (state, regional and local BGCVA and FNP personnel, church members) will be involved in program planning, implementation, evaluation and sustainability as follows: Identifying strategies to address local strengths, resources, needs and characteristics; Refining strategies to maximize cultural sensitivity for the intervention and research participation, including informed consent documents; Refining strategies to recruit churches/church members and maximize participant retention; Refining program implementation and evaluation plans to maximize program and research fidelity and participation by churches and participants in the education program and data collection; Participating in qualitative data collection during formative and process evaluation; Identifying effective methods to share project outcomes with local and state stakeholders; and Identifying strategies to sustain and expand the program beyond the funding period.

As for data analysis, for qualitative data, a thematic approach will be used to identify themes from semi-structured interviews and focus group discussions. Audio files will be transcribed and transcripts will be reviewed and coded for emergent themes to be checked against field notes. A second researcher will review transcripts, field notes and themes and discrepancies will be rectified. For quantitative data, descriptive univariate analyses will be conducted on all study variables. Data will be checked for outliers, violations of normality and missing data. Predictors of drop-out and non-response will be explored to better understand any discernible systematic processes in play, taking advantage of the data collected until the last time point and demographic variables. If the missingness is found to be random and ignorable, multiple imputations will be used to deal with missing data, else, an intent-to-treat approach that make full use of available data in determining treatment effects will be used for all analyses. Scale scores will be calculated for all outcomes. Because each family (parent-child dyad) is nested within churches, and because there may be more than one parent or more than one child from each family in the program, the investigators will have the advantage of testing family-level effects as well as parent- or child-level effects. A three-level clustered longitudinal model with growth trajectories will be assessed. Quantitative and qualitative outcomes will be triangulated in order to identify the most significant influences on feasibility and sustainability of the interventions and intervention partnerships and on church capacity, readiness, and environment for engaging in health related programming. ;

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT03980262
• Study type: Interventional
• Source: Virginia Polytechnic Institute and State University
• Status: Terminated
• Phase: N/A
• Start date: February 19, 2019
• Completion date: September 11, 2021