Skip to main content
OpenTrials
Completed

NCT Number: NCT05917093

Healthy Living for You

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grace Fellowship Church, Milwaukee, Wisconsin, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

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.

Other names: Healthy Living With Diabetes

Primary outcomes

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

    Time frame: up to 6 months

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

    Time frame: up to 6 months

  3. Summary of Reasons for Agreeing to Participate Reported by Participant Count

    Time frame: up to 6 months

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

  4. Summary of Reasons for Declining to Participate Reported by Participant Count

    Time frame: up to 6 months

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

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

    Time frame: up to 6 months

  6. Retention Rate during a 6-week Session

    Time frame: Up to 6 weeks

  7. Summary of Reasons for Dropping Out by Participant Count

    Time frame: up to 6 months

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

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Effectiveness: Self-Reported Health Status

    Time frame: 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.

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

    Time frame: up to 6 months

  5. Facilitator Evaluation Reported in binary Yes / No

    Time frame: 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?

  6. Facilitator Feedback

    Time frame: up to 6 months

    Qualitative measure to be coded and themed, summarizing barriers to adoption.

  7. Implementation: Weekly Session Attendance

    Time frame: up to 6 weeks

  8. Implementation: Summary of Diabetes Self-Care Activities (SDSCA)

    Time frame: 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.

  9. Implementation: Participant Satisfaction Ratings

    Time frame: up to 6 weeks

    Participant Satisfaction Ratings are scored from 1-5, with higher scores indicating higher satisfaction.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • UW Institute of Clinical and Translational Research

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2023
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.