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

An Intergenerational CBPR Intervention to Reduce Appalachian Health Disparities

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: LHA-delivered energy balance classes/activities

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.

• Study Type: Interventional
• Enrollment (Actual): 1250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Whitesburg, Kentucky, United States
      • Faith Moves Mountains

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Intervention; Participants are nested in churches which were randomly assigned to receive the intervention first.	Behavioral: LHA-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.
No Intervention: Delayed Intervention; 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?

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
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
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

Collaborators and Investigators

• Sponsor: Nancy Schoenberg
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Nancy Schoenberg, Ph.D., University Of Kentucky

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 8, 2011
• First Submitted That Met QC Criteria: June 13, 2011
• First Posted (Estimate): June 14, 2011

Study Record Updates

• Last Update Posted (Estimate): July 13, 2015
• Last Update Submitted That Met QC Criteria: July 10, 2015
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: obesity; Overweight; energy balance; families; Appalachian; intergenerational; group-randomized trial
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: R01DK081324 (U.S. NIH Grant/Contract)