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An Intergenerational Community Based Participatory Research (CBPR) Intervention to Reduce Appalachian Health Disparities

An Intergenerational CBPR Intervention to Reduce Appalachian Health Disparities

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01373307
Enrollment
1250
Registered
2011-06-14
Start date
2010-03-31
Completion date
2014-06-30
Last updated
2015-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Overweight, obesity, Appalachian, intergenerational, families, energy balance, group-randomized trial

Brief summary

The study purpose is to evaluate the effectiveness of a culturally appropriate, faith-placed lay health advisor intervention aimed at increasing fruit and vegetable intake and physical activity among intergenerational Appalachian individuals and families.

Detailed description

The developmental phase of this project incorporated community based participatory research (CBPR) principles to identify the needs and preferences of community members with regard to energy balance. In the intervention phase, this group-randomized trial administers and evaluates an intergenerational, culturally appropriate energy balance intervention aimed at increasing fruit and vegetable intake and increasing physical activity among participants in 6 distressed Appalachian counties. Faith institutions are recruited and randomized to treatment or wait-list control conditions, and participants are recruited and enrolled within those institutions. Focusing on Appalachian children, parents, and grandparents, local lay health advisors deliver a series of group presentations, adapted from We Can! and Media Smart Youth. In addition, the project provides culturally consonant leave-behind booster activities, including square dances, cooking classes, and community gardens.

Interventions

BEHAVIORALLHA-delivered energy balance classes/activities

4-6 sessions delivered by local LHA to age-appropriate groups (i.e., children/adolescents and adults), based on We Can! And Media Smart Youth curricula.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Nancy Schoenberg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age 8 years or above * Able to provide informed consent/assent

Design outcomes

Primary

MeasureTime frameDescription
Change in self-reported fruit and vegetable intake from baselineAssessed approximately 4 months after baselineAmount of fruit and vegetable intake is measured using an FFQ, pretested in focus groups comprised of members of the target population. Positive change (i.e., increasing fruit and vegetable intake) from baseline to post-test will be coded as 1, while negative or no change will be coded 0. This assessment occurs after the Early Treatment group has completed the intervention.
Change in self-reported physical activity from baselineAssessed at approximately 4 months after baselineAmount of physical activity is measured using instruments with demonstrated reliability and validity, pretested in focus groups comprised of members of the target population. Positive change (i.e., increasing physical activity) from baseline to post-test will be coded as 1, while negative or no change will be coded 0. This assessment occurs after the Early Treatment group has completed the intervention.
Change in body mass index (BMI) from baselineAssessed at approximately 4 months after baselinePositive change (i.e., decreasing BMI when indicated, or maintaining BMI when not indicated) from baseline to post-test will be coded as 1, while negative or no change will be coded 0. This assessment occurs after the Early Treatment group has completed the intervention.

Secondary

MeasureTime frameDescription
Change in stage of readiness to change each health behavior (i.e., fruit and vegetable intake, physical activity) from baselineAssessed approximately 4 months after baselineStage of readiness to change is measured using instruments with demonstrated reliability and validity, pretested in focus groups comprised of members of the target population. Positive change in stage of readiness from baseline to post-test will be coded as 1, while negative or no change will be coded 0. This assessment occurs after the Early Treatment group has completed the intervention.
Number of visits completedApproximately 4 months after baselineThis process measure will reflect the number of visits/classes attended by participants, as a means of assessing participation rate and feasibility.
Retention (i.e., number of participants who complete all planned assessment timepoints)Approximately one year after baselineRetention numbers will be assessed as a process measure outcome. Participants who complete all study assessment timepoints will be coded as 1, while participants who drop out will be coded 0. Number/percentage of participants who remained enrolled and complete all study procedures and assessments will be used as an indicator of feasibility in the community setting.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026