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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01373307
First Posted: June 14, 2011
Last Update Posted: July 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Nancy Schoenberg, University of Kentucky
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Intergenerational CBPR Intervention to Reduce Appalachian Health Disparities

Further study details as provided by Nancy Schoenberg, University of Kentucky:

Primary Outcome Measures:
  • 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.

  • 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 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.


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 ]
    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 ]
    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 ]
    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.


Enrollment: 1250
Study Start Date: March 2010
Study Completion Date: June 2014
Primary Completion Date: July 2012 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 8 years or above
  • Able to provide informed consent/assent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373307


Locations
United States, Kentucky
Faith Moves Mountains
Whitesburg, Kentucky, United States
Sponsors and Collaborators
Nancy Schoenberg
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Nancy Schoenberg, Ph.D. University of Kentucky
  More Information

Responsible Party: Nancy Schoenberg, Sponsor/PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT01373307     History of Changes
Other Study ID Numbers: R01DK081324 ( U.S. NIH Grant/Contract )
First Submitted: June 8, 2011
First Posted: June 14, 2011
Last Update Posted: July 13, 2015
Last Verified: December 2014

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

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms