Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05917093
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2023-06-14
Brief Title:
Healthy Living for You
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Culturally Tailoring the Delivery of an Evidence-Based Diabetes Self-Management Program for Black Adults to Enhance Its Reach Adoption Implementation and Effectiveness
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed 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 recruitmentretention 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
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 recruitmentretention 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHARMPHARMACY | OTHER | UW Madison | None |
| Protocol Version 4222024 | OTHER | None | None |