Healthy Living for You
- Conditions
- Diabetes
- Interventions
- Behavioral: Culturally tailored HLWD
- Registration Number
- NCT05917093
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
The goal of the study is to conduct the Healthy Living with Diabetes (HLWD) program among Black individuals in a culturally appropriate manner. This study will involve 24-30 participants in total. Participants can expect to be on study for approximately 6 months.
- Detailed Description
The study objectives are to recruit and empower Black Healthy Living with Diabetes (HLWD) facilitators to deliver culturally tailored HLWD content and pilot the culturally tailored HLWD program, using the RE-AIM framework and Proctor implementation outcomes to gather preliminary implementation data. The study team will partner with stakeholders and community organizations serving Black adults, including Grace Fellowship Church and YMCA of Metropolitan Milwaukee. The central hypothesis is that the cultural tailoring of HLWD will increase the reach, adoption, implementation, and effectiveness of HLWD among Black adults.
The study aims are:
1. Co-design a culturally relevant approach to the recruitment and training of Black HLWD facilitators. The study team will partner with a stakeholder advisory board including:
* (1) Black adults with diabetes (prior HLWD participants)
* (2) Black community leaders
* (3) current Black HLWD facilitators, and
* (4) current HLWD program providers (organizational leaders in settings delivering HLWD to Black adults)
to co-design: (a) an asset-based approach to recruiting Black facilitators and (b) an adjunct training that empowers the facilitator to use a culturally relevant approach to deliver HLWD content to Black adults.
2. Implement the culturally tailored HLWD program among Black adults. Using a mixed methods design, the investigators will assess recruitment/retention rates among Black adults (reach), feasibility of adoption among facilitators and program providers (adoption), participant adherence, fidelity of enactment and acceptability, fidelity of program delivery by facilitators (implementation), and pre-post impact on diabetes outcomes (effectiveness).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- self-identify as Black/African American
- have type 1 diabetes, type 2 diabetes, gestational diabetes, or pre-diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Culturally tailored HLWD Culturally tailored HLWD -
- Primary Outcome Measures
Name Time Method Recruitment: Number of Miles Participants are Willing to Travel for a Workshop up to 6 months Retention: Proportion of Participants who Completed the HLWD Workshop and Final Assessments up to 6 months Summary of Reasons for Declining to Participate Reported by Participant Count up to 6 months Qualitative measure where reasons will be coded and grouped into themes for reporting.
Recruitment: Number of HLWD Participants Enrolled in a HLWD Workshop vs Invited to Enroll up to 6 months Summary of Reasons for Agreeing to Participate Reported by Participant Count up to 6 months Qualitative measure where reasons will be coded and grouped into themes for reporting.
Retention Rate during a 6-week Session Up to 6 weeks Summary of Reasons for Dropping Out by Participant Count up to 6 months Qualitative measure where reasons will be coded and grouped into themes for reporting.
- Secondary Outcome Measures
Name Time Method Effectiveness: Diabetes Empowerment Scale - Short Form Self-Efficacy for Adherence to Medication Use Scale Baseline, 6 weeks, 6 months The Diabetes Empowerment Scale is a 8-item survey each scored on a 5 point likert scale. This scale assesses the patients' perceived ability to obtain social support, manage stress, be self-motivating and make diabetes-related decisions. A total range of score is from 0-40. Higher score indicate higher diabetes empowerment.
Implementation: Participant Satisfaction Ratings up to 6 weeks Participant Satisfaction Ratings are scored from 1-5, with higher scores indicating higher satisfaction.
Facilitator Evaluation Reported in binary Yes / No up to 6 months Facilitators will be asked if they satisfied with the training and experience of being a facilitator? Would they consider leading another program? Would they recommend being a facilitator?
Implementation: Summary of Diabetes Self-Care Activities (SDSCA) up to 6 weeks The SDSCA is a 7-item survey with each item scored from 0-7. The total possible range of scores is from 0-112, with higher scores indicating better self-care.
Effectiveness: Self-Reported Health Status Baseline, 6 weeks, 6 months Participants self-reported their overall health on a scale of by selecting one of the 5 options: poor, fair, good , very good, or excellent. Scoring is from 1-5 with higher scores indicating poor health.
Facilitator Adoption: Number Agreeing to be a Facilitator divided by the Number Approached up to 6 months Effectiveness: Patient's Perceived Involvement in Care Scale (PICS) Baseline, 6 weeks, 6 months PICS is a 13-item survey where each item is scored yes (1) or no (0) for a total range of scores from 0-13. This instrument is designed to examine three relatively distinct factors: (1) doctor facilitation of patient involvement, (2) level of information exchange, and (3) patient participation in decision making. Higher score indicate higher patient/provider communication quality.
Facilitator Feedback up to 6 months Qualitative measure to be coded and themed, summarizing barriers to adoption.
Implementation: Weekly Session Attendance up to 6 weeks
Trial Locations
- Locations (2)
YMCA
🇺🇸Milwaukee, Wisconsin, United States
Grace Fellowship Church
🇺🇸Milwaukee, Wisconsin, United States