Faith Moves Mountains: A Community Based Participatory Research (CBPR) Appalachian Wellness & Cancer Prevention Program
The study purpose is to evaluate the effectiveness of a set of culturally appropriate, faith-placed lay health advisor interventions aimed at facilitating smoking cessation and increasing cancer screening among Appalachian participants.
Behavioral: Lay health advisor interactions
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Faith Moves Mountains: A CBPR Appalachian Wellness & Cancer Prevention Program|
- Proportion of participants reporting the health behavior of interest (depending on which intervention component(s) were selected) [ Time Frame: Assessed approximately 4 months after baseline ] [ Designated as safety issue: No ]For smoking cessation: Self-reported smoking status. For cancer screenings: Self-reported receipt of cervical, breast, and/or colorectal cancer screening. This assessment occurs after the Early Treatment group has completed the intervention.
- Change in stage of readiness to change the selected health behavior(s) from baseline [ Time Frame: Assessed approximately 4 months after baseline ] [ Designated as safety issue: No ]Measured using reliable and valid instruments which were pretested in focus groups comprised of members of the target population. Positive change (i.e., increasing 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.
|Study Start Date:||March 2010|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: Early Intervention
Participants in this group are nested in churches which were randomly assigned to the treatment group.
Behavioral: Lay health advisor interactions
For smoking cessation: Cooper-Clayton group sessions plus motivational interviewing, both delivered by local lay health advisor.
For all cancer screenings: lay health advisor home visits incorporating motivational interviewing and focused on decreasing participant-identified barriers to screening.
No Intervention: Delayed Intervention
Participants in this group are nested in churches which were randomly assigned to the wait-list control group. They receive an educational luncheon focused on stress reduction during the intervention window for the Early Intervention group, and subsequently receive the intervention(s) for their selected target health behaviors at a later date.
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 cancer prevention. In the intervention phase, this group-randomized trial administers and evaluates a set of culturally appropriate interventions aimed at facilitating smoking cessation and increasing cancer screening 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. Participants select one or more targeted health behaviors from a menu including smoking cessation, colorectal cancer screening, cervical cancer screening, and breast cancer screening, and subsequently receive the intervention(s) aimed at their selected health behaviors.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373320
|United States, Kentucky|
|Faith Moves Mountains|
|Whitesburg, Kentucky, United States|
|Principal Investigator:||Nancy Schoenberg, Ph.D.||University of Kentucky|