DiabetesNCT05917093
Healthy Living for You
A study testing Culturally tailored HLWD in people with Diabetes, run by University of Wisconsin, Madison at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Culturally tailored HLWD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Apr 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-identify as Black/African American
- have type 1 diabetes, type 2 diabetes, gestational diabetes, or pre-diabetes
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
YMCA
Milwaukee, Wisconsin, 53205
Grace Fellowship Church
Milwaukee, Wisconsin, 53212
About this study
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
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.
Read the 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:
- 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).
- Conditions
- Diabetes
- Being tested
- Culturally tailored HLWD
- Keywords
- diabetes self-management, cultural tailoring, Healthy Living with Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally tailored HLWDBehavioural
Also called Healthy Living With Diabetes
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.
| Study group | Role | What they receive |
|---|---|---|
| Culturally tailored HLWD | Experimental | Not described Receives: Behavioral: Culturally tailored HLWD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment: Number of HLWD Participants Enrolled in a HLWD Workshop vs Invited to Enroll
Measured: up to 6 months
Recruitment: Number of Miles Participants are Willing to Travel for a Workshop
Measured: 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.
Measured: 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.
Measured: up to 6 months
Retention: Proportion of Participants who Completed the HLWD Workshop and Final Assessments
Measured: up to 6 months
Retention Rate during a 6-week Session
Measured: 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.
Measured: up to 6 months
Secondary outcomes (9)
Effectiveness: Diabetes Empowerment Scale - Short Form Self-Efficacy for Adherence to Medication Use Scale
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.
Measured: Baseline, 6 weeks, 6 months
Effectiveness: Patient's Perceived Involvement in Care Scale (PICS)
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.
Measured: Baseline, 6 weeks, 6 months
Effectiveness: Self-Reported Health Status
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.
Measured: Baseline, 6 weeks, 6 months
Facilitator Adoption: Number Agreeing to be a Facilitator divided by the Number Approached
Measured: up to 6 months
Facilitator Evaluation Reported in binary Yes / No
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?
Measured: up to 6 months
Facilitator Feedback
Qualitative measure to be coded and themed, summarizing barriers to adoption.
Measured: up to 6 months
Implementation: Weekly Session Attendance
Measured: up to 6 weeks
Implementation: Summary of Diabetes Self-Care Activities (SDSCA)
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.
Measured: up to 6 weeks
Implementation: Participant Satisfaction Ratings
Participant Satisfaction Ratings are scored from 1-5, with higher scores indicating higher satisfaction.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start9 Apr 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- UW Institute of Clinical and Translational Research
- Responsible party
- Sponsor
- Investigators
- Michelle Chui, PharmD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917093
- Sponsor's protocol ID
- 2023-0821
- Other IDs
- Protocol Version 7/9/2024, PHARM/PHARMACY
- Status last verified
- Nov 2024
- First submitted
- 14 Jun 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05917093
- Acronym / sponsor ID
- 2023-0821
- Conditions
- Diabetes
- Keywords
- diabetes self-management, cultural tailoring, Healthy Living with Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- UW Institute of Clinical and Translational Research
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Culturally tailored HLWD | Experimental | Behavioral: Culturally tailored HLWD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- self-identify as Black/African American
- have type 1 diabetes, type 2 diabetes, gestational diabetes, or pre-diabetes
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally tailored HLWDAlso: Healthy Living With DiabetesParticipants 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. | Behavioural | Culturally tailored HLWD |
Primary outcome
Recruitment: Number of HLWD Participants Enrolled in a HLWD Workshop vs Invited to Enroll
Time frame: up to 6 months
Recruitment: Number of Miles Participants are Willing to Travel for a Workshop
Time frame: up to 6 months
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.
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.
Retention: Proportion of Participants who Completed the HLWD Workshop and Final Assessments
Time frame: up to 6 months
Retention Rate during a 6-week Session
Time frame: Up to 6 weeks
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.
9 secondary outcomes
Effectiveness: Diabetes Empowerment Scale - Short Form Self-Efficacy for Adherence to Medication Use Scale
Time frame: Baseline, 6 weeks, 6 months
Effectiveness: Patient's Perceived Involvement in Care Scale (PICS)
Time frame: Baseline, 6 weeks, 6 months
Effectiveness: Self-Reported Health Status
Time frame: Baseline, 6 weeks, 6 months
Facilitator Adoption: Number Agreeing to be a Facilitator divided by the Number Approached
Time frame: up to 6 months
Facilitator Evaluation Reported in binary Yes / No
Time frame: up to 6 months
Facilitator Feedback
Time frame: up to 6 months
Implementation: Weekly Session Attendance
Time frame: up to 6 weeks
Implementation: Summary of Diabetes Self-Care Activities (SDSCA)
Time frame: up to 6 weeks
Implementation: Participant Satisfaction Ratings
Time frame: up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Chui, PharmD, PhD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally tailored HLWD in people with Diabetes, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment: Number of HLWD Participants Enrolled in a HLWD Workshop vs Invited to Enroll (time frame: up to 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.