Healthy Living for You

NCT05917093 | Completed

• 3 other identifiers: 2023-0821Protocol Version 7/9/2024PHARM/PHARMACY
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes

Keywords

diabetes self-management; cultural tailoring; Healthy Living with Diabetes

Outcome Measures

Primary Outcomes (7)

• Recruitment: Number of HLWD Participants Enrolled in a HLWD Workshop vs Invited to Enroll

  up to 6 months

• Recruitment: Number of Miles Participants are Willing to Travel for a Workshop

  up to 6 months

• Summary of Reasons for Agreeing to Participate Reported by Participant Count

  Qualitative measure where reasons will be coded and grouped into themes for reporting.

  up to 6 months

• Summary of Reasons for Declining to Participate Reported by Participant Count

  Qualitative measure where reasons will be coded and grouped into themes for reporting.

  up to 6 months

• Retention: Proportion of Participants who Completed the HLWD Workshop and Final Assessments

  up to 6 months

• Retention Rate during a 6-week Session

  Up to 6 weeks

• Summary of Reasons for Dropping Out by Participant Count

  Qualitative measure where reasons will be coded and grouped into themes for reporting.

  up to 6 months

Secondary Outcomes (9)

• Effectiveness: Diabetes Empowerment Scale - Short Form Self-Efficacy for Adherence to Medication Use Scale

  Baseline, 6 weeks, 6 months

• Effectiveness: Patient's Perceived Involvement in Care Scale (PICS)

  Baseline, 6 weeks, 6 months

• Effectiveness: Self-Reported Health Status

  Baseline, 6 weeks, 6 months

• Facilitator Adoption: Number Agreeing to be a Facilitator divided by the Number Approached

  up to 6 months

• Facilitator Evaluation Reported in binary Yes / No

  up to 6 months

Study Arms (1)

Culturally tailored HLWD

EXPERIMENTAL

Behavioral: Culturally tailored HLWD

Interventions

Culturally tailored HLWD BEHAVIORAL

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.

Also known as: Healthy Living With Diabetes

Culturally tailored HLWD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• UW Institute of Clinical and Translational Research: collaborator

Study Sites (2)

YMCA

Milwaukee, Wisconsin, 53205, United States

Location

Grace Fellowship Church

Milwaukee, Wisconsin, 53212, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Michelle Chui, PharmD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: April 9, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)