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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LHA-delivered energy balance classes/activities
Sponsored by
Nancy Schoenberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Overweight, obesity, Appalachian, intergenerational, families, energy balance, group-randomized trial

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • Faith Moves Mountains

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early Intervention

Delayed Intervention

Arm Description

Participants are nested in churches which were randomly assigned to receive the intervention first.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 8, 2011
Last Updated
July 10, 2015
Sponsor
Nancy Schoenberg
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01373307
Brief Title
An Intergenerational Community Based Participatory Research (CBPR) Intervention to Reduce Appalachian Health Disparities
Official Title
An Intergenerational CBPR Intervention to Reduce Appalachian Health Disparities
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nancy Schoenberg
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, obesity, Appalachian, intergenerational, families, energy balance, group-randomized trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Intervention
Arm Type
Experimental
Arm Description
Participants are nested in churches which were randomly assigned to receive the intervention first.
Arm Title
Delayed Intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LHA-delivered energy balance classes/activities
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in self-reported fruit and vegetable intake from baseline
Description
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.
Time Frame
Assessed approximately 4 months after baseline
Title
Change in self-reported physical activity from baseline
Description
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.
Time Frame
Assessed at approximately 4 months after baseline
Title
Change in body mass index (BMI) from baseline
Description
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.
Time Frame
Assessed at approximately 4 months after baseline
Secondary Outcome Measure Information:
Title
Change in stage of readiness to change each health behavior (i.e., fruit and vegetable intake, physical activity) from baseline
Description
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.
Time Frame
Assessed approximately 4 months after baseline
Title
Number of visits completed
Description
This process measure will reflect the number of visits/classes attended by participants, as a means of assessing participation rate and feasibility.
Time Frame
Approximately 4 months after baseline
Title
Retention (i.e., number of participants who complete all planned assessment timepoints)
Description
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.
Time Frame
Approximately one year after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 8 years or above Able to provide informed consent/assent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Schoenberg, Ph.D.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faith Moves Mountains
City
Whitesburg
State/Province
Kentucky
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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