Church, Extension and Academic Partners Empowering Healthy Families

NCT ID: NCT03980262

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-19
• Study Completion Date: 2021-09-11

Brief 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.

Detailed 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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy Children, Healthy Families+ (HCHF+)

HCHF+ integrates healthful eating and physical activity with parenting education (parent role modeling and child feeding practices) and was recently shown to improve parent and child nutrition behaviors for participants in the Expanded Food and Nutrition Education (EFNEP) program. OrganWise Guys (OWG) will be used for children in first and second grades (ages 6-8). Choose Health: Food, Fun and Fitness (CHFF), developed by Cornell University, will be used for children in grades three through five (ages 8-10). HCHF+ includes 9 sessions to be delivered weekly.

Group Type: EXPERIMENTAL

Healthy Children, Healthy Families+ (HCHF+)

Intervention Type: BEHAVIORAL

HCHF+ integrates healthful eating and physical activity with parenting education (parent role modeling and child feeding practices) and was recently shown to improve parent and child nutrition behaviors for participants in the Expanded Food and Nutrition Education (EFNEP) program. OrganWise Guys (OWG) will be used for children in first and second grades (ages 6-8). Choose Health: Food, Fun and Fitness (CHFF), developed by Cornell University, will be used for children in grades three through five (ages 8-10). HCHF+ includes 9 sessions to be delivered weekly.

MoneySmart

A financial education program available through the Federal Deposit Insurance Corporation. Money Smart includes programs for adults and school-aged children, a parent/caregiver guide and a train-the-trainer program. MoneySmart is an Extension-approved program designed to improve money-management practices and financial confidence for parents MoneySmart involves eight weekly sessions that includes one-to-two hour modules with take-home guides for adults. For children, there are eight sessions that include take-home worksheets and a parent/caregiver guide.

Group Type: ACTIVE_COMPARATOR

Money Smart

Intervention Type: BEHAVIORAL

Money Smart is a financial literacy education program developed by the Federal Deposit Insurance Corporation (FDIC). Curricula are available for both adults and children.

Interventions

Healthy Children, Healthy Families+ (HCHF+)

HCHF+ integrates healthful eating and physical activity with parenting education (parent role modeling and child feeding practices) and was recently shown to improve parent and child nutrition behaviors for participants in the Expanded Food and Nutrition Education (EFNEP) program. OrganWise Guys (OWG) will be used for children in first and second grades (ages 6-8). Choose Health: Food, Fun and Fitness (CHFF), developed by Cornell University, will be used for children in grades three through five (ages 8-10). HCHF+ includes 9 sessions to be delivered weekly.

Intervention Type: BEHAVIORAL

Money Smart

Money Smart is a financial literacy education program developed by the Federal Deposit Insurance Corporation (FDIC). Curricula are available for both adults and children.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• a parent or primary caregiver and child (age 6-10) dyad living in the same household
• English-speaking

Exclusion Criteria

• Parent does not have a child between the ages of 6 and 11
• Target child does not live or spend significant time with parent/caregiver
• non-English speaking

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baptist General Convention of Virginia

UNKNOWN

Sponsor Role: collaborator

Virginia Cooperative Extension

UNKNOWN

Sponsor Role: collaborator

Virginia Family Nutrition Program

UNKNOWN

Sponsor Role: collaborator

Virginia Tech Center for Public Health Practice and Research

UNKNOWN

Sponsor Role: collaborator

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Kathryn W. Hosig

Associate Professor, Department of Population Health Sciences & Director, Center for Public Health Practice and Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baptist General Convention of Virginia

Richmond, Virginia, United States

Countries

United States

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Other Identifiers

2018-68001-27549

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2017-07071

Identifier Type: -

Identifier Source: org_study_id