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

Obesity Clinical Trial

Official title:

An Intergenerational CBPR Intervention to Reduce Appalachian Health Disparities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373307
• Other study ID #: R01DK081324
• Secondary ID: R01DK081324
• Status: Completed
• Phase: N/A
• First received: June 8, 2011
• Last updated: July 10, 2015
• Start date: March 2010
• Est. completion date: June 2014

Study information

• Verified date: December 2014
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1250
• Est. completion date: June 2014
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• Age 8 years or above

• Able to provide informed consent/assent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
United States	Faith Moves Mountains	Whitesburg	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Nancy Schoenberg	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No