Healthy Living for You

Study Overview
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Brief Summary
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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
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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: 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. 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).

Official Title
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Culturally Tailoring the Delivery of an Evidence-Based Diabetes Self-Management Program for Black Adults to Enhance Its Reach, Adoption, Implementation, and Effectiveness

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Culturally tailored HLWD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: self-identify as Black/African American have type 1 diabetes, type 2 diabetes, gestational diabetes, or pre-diabetes Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culturally tailored HLWD<br> | Behavioral: Culturally tailored HLWD<br>* Participants receive the culturally tailored HLWD intervention for 6 weeks Week 0 - Baseline enrollment. Weeks 1-6 will consist of 6 separate group sessions. Diabetes self-management topics will be covered by 2 Black HLWD Facilitators. Participants will meet once a week, for a 2½-hour session, in community settings such as a community center, or church.<br>* Other names: Healthy Living With Diabetes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Glucose | Hemoglobin A1c (A1C), will be measured using A1cNow+, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test. | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DOSE-Nonadherence Survey | The DOSE-Nonadherence measure screens for nonadherence and is calculated by computing the mean of the 3 items (range of score is 1-5). Mean scores of 3 (i.e., scoring 1 on each of the 3 items) will be classified as nonadherent, while all mean scores >3 will be classified as adherent. | Baseline, 6 weeks, 6 months | 
| Adherence to Refills and Medicines Scale for Diabetes (ARMS-D) Score | The ARMS-D is a 12-item survey where each item is scored from from 1=none of the time to 4=all of the time, summed for an overall adherence score from 12-48, with higher scores representing more problems with medication adherence. | Baseline, 6 weeks, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes self-management, cultural tailoring, Healthy Living with Diabetes