Faith Moves Mountains: A Community Based Participatory Research (CBPR) Appalachian Wellness & Cancer Prevention Program

October 21, 2013 updated by: Nancy Schoenberg

Faith Moves Mountains: A 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

1415

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Whitesburg, Kentucky, United States
        • Faith Moves Mountains

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • For smoking cessation: age 18 or older; current cigarette smoker; able to provide informed consent
  • For cervical cancer screening: female; age 18 or older AND outside of screening guidelines; able to provide informed consent
  • For breast cancer screening: female; age 40 or older AND outside of screening guidelines; able to provide informed consent
  • For colorectal cancer screening: age 40 or older AND outside of screening guidelines; able to provide informed consent

Exclusion Criteria:

  • For smoking cessation: None
  • For cervical cancer screening: History of cervical cancer; history of hysterectomy
  • For breast cancer screening: History of breast cancer
  • For colorectal cancer screening: History of colorectal cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed approximately 4 months after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed approximately 4 months after baseline
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.
Approximately 4 months after baseline
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.
Approximately one year after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nancy Schoenberg

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Nancy Schoenberg, Ph.D., University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

June 10, 2011

First Submitted That Met QC Criteria

June 13, 2011

First Posted (Estimate)

June 14, 2011

Study Record Updates

Last Update Posted (Estimate)

October 23, 2013

Last Update Submitted That Met QC Criteria

October 21, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R24MD002757 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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