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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nancy Schoenberg, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01373307
First received: June 8, 2011
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Overweight
Obesity
Behavioral: LHA-delivered energy balance classes/activities

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Intergenerational CBPR Intervention to Reduce Appalachian Health Disparities

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Change in self-reported fruit and vegetable intake from baseline [ Time Frame: Assessed approximately 4 months after baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Assessed at approximately 4 months after baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Assessed at approximately 4 months after baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Assessed approximately 4 months after baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Approximately 4 months after baseline ] [ Designated as safety issue: No ]
    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) [ Time Frame: Approximately one year after baseline ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1750
Study Start Date: March 2010
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 8 years or above
  • Able to provide informed consent/assent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373307

Locations
United States, Kentucky
Faith Moves Mountains
Whitesburg, Kentucky, United States
Sponsors and Collaborators
Nancy Schoenberg
Investigators
Principal Investigator: Nancy Schoenberg, Ph.D. University of Kentucky
  More Information

No publications provided

Responsible Party: Nancy Schoenberg, Sponsor/PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT01373307     History of Changes
Other Study ID Numbers: R01DK081324, R01DK081324
Study First Received: June 8, 2011
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Overweight
obesity
Appalachian
intergenerational
families
energy balance
group-randomized trial

Additional relevant MeSH terms:
Overweight
Obesity
Body Weight
Signs and Symptoms
Overnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 16, 2014