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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

June 8, 2011
October 21, 2013
March 2010
December 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01373307 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
  • Overweight
  • Obesity
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.
  • Experimental: Early Intervention
    Participants are nested in churches which were randomly assigned to receive the intervention first.
    Intervention: Behavioral: LHA-delivered energy balance classes/activities
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
1750
Not Provided
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 8 years or above
  • Able to provide informed consent/assent
Both
8 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01373307
R01DK081324, R01DK081324
No
Nancy Schoenberg, University of Kentucky
Nancy Schoenberg
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Nancy Schoenberg, Ph.D. University of Kentucky
University of Kentucky
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP