Healthy Living for You

University of Wisconsin (UW)

Status: Completed

Conditions: Diabetes

Treatments: Behavioral: Culturally tailored HLWD

Study type: Interventional

Funder types: Other

Identifiers

NCT05917093

2023-0821

Protocol Version 7/9/2024 (Other Identifier)

PHARM/PHARMACY (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• self-identify as Black/African American
• have type 1 diabetes, type 2 diabetes, gestational diabetes, or pre-diabetes

Exclusion criteria

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

32 participants in 1 patient group

Culturally tailored HLWD

Experimental group

Treatment:

Behavioral: Culturally tailored HLWD