All research methods, materials and protocols for this study were reviewed and approved by the Institutional Review Board of the University of Colorado, Denver, Colorado.
Community Engagement for Program Development
Center for African American Health is a community-based organization providing disease prevention and management programs to African Americans living in the metro Denver area. Included within CAAH is Faith and Health Ministries (FHM), representing a consortium of over 60 African American churches. Through FHM, CAAH provides culturally appropriate programs and services on diabetes, cardiovascular disease, breast cancer, prostate cancer, and health literacy.
In collaboration with CAAH, a series of four half-day partnership summits were convened. Invitations to participate in these summits, which spanned a period of about 15 months, were extended to all church members within FHM. Summit 1 (n=116) provided background information and a context for the CBPR collaboration with FHM. The general theme of developing and testing a health and wellness program to promote cancer prevention was also introduced, as specified in the funding mechanism that supported this collaboration. Summit 2 (n=68) provided a brief overview of potential behavioral targets (diet, nutrition, physical activity, cancer screening), along with data from the Colorado Behavioral Risk Factor Surveillance System (BRFSS) that illustrated statewide disparities in these areas. Summit participants expressed a strong preference to conduct a diet, nutrition and physical activity intervention using a small-group, interpersonal format.
Between Summits 2 and 3, a research working group was convened that consisted of 15 participants, 10 of whom were from the community with the remainder from the university-based research team. The research working group was charged with taking the recommendations obtained during the previous summits and translating them into draft intervention concepts that would be reviewed during Summit 3. Using an audience response system (ARS), a series of follow-up questions asked during Summit 3 (n=45) determined that participants preferred a program delivery schedule of two-three times per week; that the preferred venues were CAAH (38%) and churches (31%); that having a buddy system (84%) and information about food preparation (97%) were strongly endorsed, and that the physical activity component should include walking groups (58%), strength and resistance training (53%), aerobics (44%), and Pilates/stretching (32%). Use of step counters, taste-testing classes and recipe makeovers also emerged as recommended program components, as did an educational module focused on cancer screening. When asked whether this participatory planning process had been helpful, 97% of summit participants answered in the affirmative.
After Summit 3, program staff from CAAH and the university-based research team developed the penultimate version of the intervention concept. The proposed intervention, presented at Summit 4 (n=48), included a 2-month diet and nutrition program delivered at participating churches two times per week. Additional components included an individualized wellness plan, home-based strategies, cooking demonstrations using church kitchens (one reason why churches were selected instead of CAAH as the venue for the intervention), and an educational module that would review various cancer screening tests. At Summit 4, a facilitated discussion also occurred regarding the importance of program evaluation and the value of including randomized comparison or control groups, why research has practical value to the community (eg, to help identify programs that work), and why pilot studies are often needed before larger studies and service programs can be funded.
During Summit 4, participants were asked if they would consider joining this study if the comparison group received nothing at all. Using ARS, about 60% answered yes. The percentage increased to 91% if the comparison group received a less intensive intervention. Most participants (65%) supported randomization as the method for group assignment. Almost no participants (4%) felt that assessing clinical endpoints would be a barrier to participation, and 80% indicated that requiring a medical release from a physician would not be a barrier. Summit 4 concluded by assessing satisfaction with the summit (85% very satisfied, 15% satisfied) and whether the summit was useful (100% yes).
Research Design and Recruitment
A randomized pilot study was conducted where LWBF was compared to a minimal intervention control group, and where the unit of randomization was the church. An invitation to participate was extended to all FHM churches. Twelve churches initially expressed interest, and six were randomly selected and pair-matched based on church size (large, medium, small). Within each pair, one church was randomly assigned to either the control condition or the LWBF program. One church withdrew after its pastor was assigned to another church, resulting in three intervention and two control churches.
Each church made recruiting materials available for at least three weeks and pastors actively encouraged their members to participate. A separate orientation meeting was scheduled at each church, during which interested church members could learn more about the study and receive pre-enrollment materials (informed consent, baseline clinical assessment appointments, baseline self-administered questionnaire, and medical release for physician signature). Enrollment was completed during the baseline clinical assessments conducted at CAAH, where group assignment was also disclosed to participants.
Eligible participants included men and women recruited from participating churches who were aged ≥18 years, gave written informed consent, completed a self-administered baseline questionnaire and provided a physician-signed medical release at the baseline assessment. During the baseline assessments, participants were also interviewed by a physician to determine whether there were contraindications that would preclude participation. All church members who chose to undergo eligibility screening were subsequently enrolled, including 74 participants from intervention churches and 32 participants from control churches.
Assessments of the clinical endpoints occurred at CAAH. These included blood pressure obtained by a research nurse using an arm or thigh cuff and stethoscope; height, weight and BMI using a stadiometer and a medically approved digital scale; % body fat based on a five site measurement using Lange skin fold calipers; and a cardiovascular fitness step test based on the YMCA protocol, where scores were categorized from excellent to very poor using ageand sex-specific criteria.12
The clinical assessment team, which consisted of certified fitness specialists, dietitians and registered nurses, completed an assessment training program that included demonstrations and a hands-on practicum. All members of the assessment team were blinded to group assignment.
The baseline self-administered questionnaire assessed sociodemographic characteristics of participants, general and functional health status and comorbidities, self-reported diet, nutrition and physical activity practices, and cancer screening practices, many of which were drawn from the BRFSS. Additional questions assessed prescription medications as well as motivation and self-efficacy in making dietary and physical activity changes.
Two Month Follow-Up Assessments
For the two-month follow-up assessments, the participation rate for the control group was 75% (24 of 32), compared to 97% (72 of 74) for the intervention group. The same clinical endpoints were assessed at two months follow-up using the same assessment team and procedures as at baseline. The two-month follow-up questionnaire, which was completed on-site during the clinical assessments, replicated many of the questions asked at baseline. Other questions asked LWBF participants to rate intervention staff on various dimensions, including providing information that was new, helpful and understandable, and whether the intervention staff were caring, involved everyone in the group sessions, provided good examples and were motivating for the participant. Intervention participants were also asked to rate the individualized wellness plans in terms of helpfulness and whether they thought it was a good idea to deliver this program at their church. Both intervention and control participants were asked how much of the print materials they read and to rate these materials on many of the same dimensions used for intervention staff. All participants were asked their level of satisfaction with the program they received, and whether they would recommend their program to others.