Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
32 participants
INTERVENTIONAL
2024-04-09
2024-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
In-Person Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes
NCT06557317
Peers LEAD Plus Healthy Living With Diabetes (HLWD)
NCT04857411
Self-Management in African Americans With Diabetes and Hypertension
NCT01244152
REACH Detroit Partnership Family Intervention
NCT00800410
Pilot Project of Health Promotion for People With Diabetes
NCT00970294
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Culturally tailored HLWD
Culturally tailored HLWD
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Culturally tailored HLWD
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* have type 1 diabetes, type 2 diabetes, gestational diabetes, or pre-diabetes
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
UW Institute of Clinical and Translational Research
UNKNOWN
University of Wisconsin, Madison
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michelle Chui, PharmD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
YMCA
Milwaukee, Wisconsin, United States
Grace Fellowship Church
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Protocol Version 7/9/2024
Identifier Type: OTHER
Identifier Source: secondary_id
PHARM/PHARMACY
Identifier Type: OTHER
Identifier Source: secondary_id
2023-0821
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.