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Completed

NCT Number: NCT01373307

An Intergenerational Community Based Participatory Research (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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faith Moves Mountains

Whitesburg, Kentucky, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

LHA-delivered energy balance classes/activities

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Nancy Schoenberg

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

An Intergenerational CBPR Intervention to Reduce Appalachian Health Disparities

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Jun 14, 2011
Registry last updated
Jul 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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