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Clinical Trials/NCT01373307
NCT01373307
Completed
Not Applicable

An Intergenerational CBPR Intervention to Reduce Appalachian Health Disparities

Nancy Schoenberg1 site in 1 country1,250 target enrollmentMarch 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overweight
Sponsor
Nancy Schoenberg
Enrollment
1250
Locations
1
Primary Endpoint
Change in body mass index (BMI) from baseline
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
June 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nancy Schoenberg
Responsible Party
Sponsor Investigator
Principal Investigator

Nancy Schoenberg

Sponsor/PI

University of Kentucky

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in body mass index (BMI) from baseline

Time Frame: Assessed at approximately 4 months after 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.

Change in self-reported physical activity from baseline

Time Frame: Assessed at approximately 4 months after 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.

Change in self-reported fruit and vegetable intake from baseline

Time Frame: Assessed approximately 4 months after 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.

Secondary Outcomes

  • Change in stage of readiness to change each health behavior (i.e., fruit and vegetable intake, physical activity) from baseline(Assessed approximately 4 months after baseline)
  • Number of visits completed(Approximately 4 months after baseline)
  • Retention (i.e., number of participants who complete all planned assessment timepoints)(Approximately one year after baseline)

Study Sites (1)

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