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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Intergenerational CBPR Intervention to Reduce Appalachian Health Disparities

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: LHA-delivered energy balance classes/activities


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 8 years or above Able to provide informed consent/assent

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Intervention<br>Participants are nested in churches which were randomly assigned to receive the intervention first. | Behavioral: LHA-delivered energy balance classes/activities<br>* 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.<br>|
| No Intervention: Delayed Intervention<br>Wait-list control group. Participants are nested in churches which were randomly assigned to receive the intervention at a later date. Delayed Intervention participants receive an educational luncheon addressing stress reduction during the window of no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported fruit and vegetable intake from baseline | Amount 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. | Assessed approximately 4 months after baseline | 
| Change in self-reported physical activity from baseline | Amount 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. | Assessed at approximately 4 months after baseline | 
| Change in body mass index (BMI) from baseline | Positive 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. | Assessed at approximately 4 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stage of readiness to change each health behavior (i.e., fruit and vegetable intake, physical activity) from baseline | Stage 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. | Assessed approximately 4 months after baseline | 
| Number of visits completed | This process measure will reflect the number of visits/classes attended by participants, as a means of assessing participation rate and feasibility. | Approximately 4 months after baseline | 
| Retention (i.e., number of participants who complete all planned assessment timepoints) | Retention 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. | Approximately one year after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, obesity, Appalachian, intergenerational, families, energy balance, group-randomized trial