Faith Moves Mountains: A Community Based Participatory Research (CBPR) Appalachian Wellness & Cancer Prevention Program
|ClinicalTrials.gov Identifier: NCT01373320|
Recruitment Status : Completed
First Posted : June 14, 2011
Last Update Posted : October 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Cervical Cancer Breast Cancer Colorectal Cancer||Behavioral: Lay health advisor interactions||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1415 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Faith Moves Mountains: A CBPR Appalachian Wellness & Cancer Prevention Program|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
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.
- 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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373320
|United States, Kentucky|
|Faith Moves Mountains|
|Whitesburg, Kentucky, United States|
|Principal Investigator:||Nancy Schoenberg, Ph.D.||University of Kentucky|