Diabetes Mellitus, Type 2MenDIIINCT06574035
Michigan Men's Diabetes Project III(MenDIII): Mind and Motion
A study testing Cognitive Behavioral Therapy, Exercise and Group Discussions - Ongoing Support in people with Diabetes Mellitus, Type 2 and Depressive Symptoms, run by University of Michigan at 1 site in United States.
Trial summary
The Michigan Men's Diabetes Project III: Mind \& Motion is an 7-month pilot randomized clinical trial. The investigators are looking to recruit 80 Black men with type 2 diabetes (T2D) (need to have diagnosis for at least one year) that are over the age of 18. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Diabetes Mellitus, Type 2, Depressive Symptoms, Depression
- What is being tested?
- Cognitive Behavioral Therapy, Exercise and Group Discussions - Ongoing Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to 28 Aug 2026
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American/Black males
- age 18 years or older
- ambulatory status
- diagnosis of Type 2 Diabetes (T2D) for one year duration or longer
- be under the care of a physician for their diabetes, self report an A1C of 7.0% or more in the last year
- be willing to participate in study events (weekly physical activity, exercise and CBT sessions, group discussion sessions, and in-person health assessments)
Show all 9Show fewer
- have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet/phone/computer to complete study related tasks
- live in the Wayne or Washtenaw County\
- have reliable transportation to in-person events
Who cannot join
- stage 2 hypertension as defined by Joint National Committee (JNC) VIII
- recent cardiac events
- recent laser surgery for proliferative retinopathy
- history of stroke
- lower limb amputation
- peripheral neuropathy
Show all 24Show fewer
- severe Chronic Obstructive Pulmonary Disease (COPD) (e.g., basal oxygen)
- class III or IV heart failure
- medical instability.
- Per American College of Sports Medicine (ACSM) guidelines, medical exclusion criteria will also include currently experiencing:
- ongoing unstable angina
- uncontrolled cardiac arrhythmia with hemodynamic compromise
- active endocarditis
- symptomatic severe aortic stenosis
- acute myocarditis or pericarditis
- acute aortic dissection
- acute pulmonary embolism
- pulmonary infarction
- deep venous thrombosis
- physical disability that precludes safe and adequate testing
- chest discomfort with exertion
- unreasonable breathlessness, or dizziness, fainting, or blackouts.
- As part of the screening process, the investigators will ask the participant to self-report on these conditions. Participants who are currently receiving psychotherapy services for the treatment of depression from a mental health provider will be excluded. Participants who are currently receiving only medication management from a psychiatrist will be included.
- If you are interested in the study, please complete our screening survey: https://redcapproduction.umms.med.umich.edu/surveys/?s=JNPPEDANX7KLPPF9. Thank you so much!
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Michigan Men's Diabetes Project 3 (MenD 3): Mind and Motion
The Michigan Men's Diabetes Project III: Mind \& Motion is an 7-month pilot randomized clinical trial. The investigators are looking to recruit 80 Black men with type 2 diabetes (T2D) (need to have diagnosis for at least one year) that are over the age of 18. Participants also must be under the care of a physician for their diabetes, self report an Hemoglobin A1c (A1C) of 7.0% or more in the last year, be willing to participate in study events (weekly physical activity, exercise and Cognitive Behavioral Therapy (CBT) sessions, group discussion sessions, and in-person health assessments), have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet/phone/computer to complete study related tasks, live in the Wayne or Washtenaw County, and have reliable transportation to in-person events. All participants will receive 8 hours/sessions of cognitive behavioral therapy. Participants randomized to the intervention arm will also receive 8 sessions of guided exercise at the same time. Following that they will also receive 8 group discussion sessions that will serve as on-going support. All sessions will be help via Zoom. Additionally, all participants will participate in The 4 health assessments will take place at baseline, 10 weeks, 18 weeks, and 30 weeks.
- Conditions
- Diabetes Mellitus, Type 2, Depressive Symptoms, Depression
- Being tested
- Cognitive Behavioral Therapy, Exercise, Group Discussions - Ongoing Support
- Medical subject headings
- Diabetes Mellitus, Type 2, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Cognitive behavioral therapy focuses on the unique needs of men. A culturally adapted CBT program will be administered to participants as it has demonstrated increased effectiveness for marginalized populations. Cognitive Behavioral Therapy (CBT) aligns well with these cultural needs due to its individualized approach, non-judgmental stance, collaborative nature, and emphasis on empowerment through skills building.
ExerciseBehavioural
Research demonstrates a preference for physical activity interventions among men with chronic illnesses, while highlighting limited access to fitness facilities in low-income urban areas as a barrier to participation. Online physical activity interventions have shown efficacy and cost-effectiveness in improving health behaviors, with virtual exercise programs for low-income African American populations demonstrating significant reductions in depressive symptoms. Therefore participants will receive exercise to help improve their diabetes self-management behaviors and depressive symptoms.
Group Discussions - Ongoing SupportBehavioural
Participants will join group discussions that will serve as on-going support. The small group component is designed to foster self-efficacy, autonomous motivation, and enjoyment by integrating skills building, personal values, spirituality, and goal setting. This approach has shown positive outcomes in previous pilot studies with African American men, serving as a source of vicarious learning and social support.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants randomized to the intervention group will receive 8 one hour virtual sessions of individual cognitive behavioral therapy (CBT) that will take place via U-M Zoom, which is a HIPAA compliant virtual conferencing platform.
Participants in this group will also receive 8 one hour virtual sessions of individual exercise.
Participants in this group will also receive 8 one hour virtual group discussion sessions that will serve as on-going support. This group (4-8 participants) discussion will be facilitated by one CBT Interventionist and one Exercise Interventionist. These sessions will take place following the individual sessions of CBT and Exercise. Receives: Behavioral: Cognitive Behavioral Therapy; Behavioral: Exercise; Behavioral: Group Discussions - Ongoing Support |
| Control Group | Active comparator | Participants randomized to the control group will receive enhanced usual care (EUC). The EUC group will receive 8 sessions of standard Cognitive Behavioral Therapy. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in A1C
Anthropometric/clinical data
Measured: Screening, Baseline, 10 weeks, 18 weeks, 30 weeks
Change in General Quality of Life (12-Item Short Form Survey (SF-12))
Survey Data - 12 questions covering physical and mental health domains - Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Measured: Baseline, 10 weeks, 18 weeks, 30 weeks
Change in Diabetes-Related Distress (The Type 2 Diabetes Distress Assessment System)
Survey Data - The assessment system has two components: The Core Distress Scale and The Sources Scale. The CORE DISTRESS SCORE is simply the average of the 8 items of the CORE SCALE, with each item rated on a 1 to 5 scale: Mean score < 2.0 indicate little or no distress, Mean score between 2.0 and 2.9 indicate moderate distress, Mean score > 3.0 indicate high distress. The Sources scale aims to find the sources of the distress, whether CORE DISTRESS is high or low, it is helpful to identify those aspects of living with diabetes that are contributing to the individual's diabetes distress.
Measured: Baseline, 10 weeks, 18 weeks, 30 weeks
Change in Diabetes Quality of Life (Diabetes Quality of Life Instrument)
Survey Data - Survey answers range for each section of the survey asking about satisfaction, worry, and impact of diabetes. The DQoL measure consists of 46 items ranked on a 5-point Likert scale. Individual domain and DQoL total scores range from 0 (lowest possible QoL) to 100 (highest possible QoL).
Measured: Baseline, 10 weeks, 18 weeks, 30 weeks
Secondary outcomes (1)
Change in Diabetes Self-Efficacy (Perceived Diabetes Self-Management Scale)
Survey Data - The scale is an 8-item scale that uses a 5-point Likert scale to measure self-efficacy in diabetes management. The scale ranges from 8 to 40 points, with higher scores indicating greater self-efficacy.
Measured: Baseline, 10 weeks, 18 weeks, 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start13 Jan 2025
- Primary completion28 Aug 2026
- Study completion28 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaclynn Hawkins, University of Michigan
- Investigators
- Jaclynn Hawkins, PhD, Principal investigator, University of Michigan, School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574035
- Sponsor's protocol ID
- HUM00256519
- Acronym
- MenDIII
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Michigan Men's Diabetes Project 3 (MenD 3): Mind and Motion
- ClinicalTrials.gov ID
- NCT06574035
- Acronym / sponsor ID
- MenDIII / HUM00256519
- Conditions
- Diabetes Mellitus, Type 2, Depressive Symptoms, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 28 Aug 2026 (actual)
- Study completion
- 28 Aug 2026 (actual)
- First posted
- 27 Aug 2024 (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 Michigan Men's Diabetes Project III: Mind \& Motion is an 7-month pilot randomized clinical trial. The investigators are looking to recruit 80 Black men with type 2 diabetes (T2D) (need to have diagnosis for at least one year) that are over the age of 18. Participants also must be under the care of a physician for their diabetes, self report an Hemoglobin A1c (A1C) of 7.0% or more in the last year, be willing to participate in study events (weekly physical activity, exercise and Cognitive Behavioral Therapy (CBT) sessions, group discussion sessions, and in-person health assessments), have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet/phone/computer to complete study related tasks, live in the Wayne or Washtenaw County, and have reliable transportation to in-person events. All participants will receive 8 hours/sessions of cognitive behavioral therapy. Participants randomized to the intervention arm will also receive 8 sessions of guided exercise at the same time. Following that they will also receive 8 group discussion sessions that will serve as on-going support. All sessions will be help via Zoom. Additionally, all participants will participate in The 4 health assessments will take place at baseline, 10 weeks, 18 weeks, and 30 weeks.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Cognitive Behavioral Therapy, Behavioral: Exercise, Behavioral: Group Discussions - Ongoing SupportParticipants randomized to the intervention group will receive 8 one hour virtual sessions of individual cognitive behavioral therapy (CBT) that will take place via U-M Zoom, which is a HIPAA compliant virtual conferencing platform. Participants in this group will also receive 8 one hour virtual sessions of individual exercise. Participants in this group will also receive 8 one hour virtual group discussion sessions that will serve as on-going support. This group (4-8 participants) discussion will be facilitated by one CBT Interventionist and one Exercise Interventionist. These sessions will take place following the individual sessions of CBT and Exercise. |
| Control Group | Active comparator | Behavioral: Cognitive Behavioral TherapyParticipants randomized to the control group will receive enhanced usual care (EUC). The EUC group will receive 8 sessions of standard Cognitive Behavioral Therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- African American/Black males
- age 18 years or older
- ambulatory status
- diagnosis of Type 2 Diabetes (T2D) for one year duration or longer
- be under the care of a physician for their diabetes, self report an A1C of 7.0% or more in the last year
Key exclusion criteria (24 listed)
- stage 2 hypertension as defined by Joint National Committee (JNC) VIII
- recent cardiac events
- recent laser surgery for proliferative retinopathy
- history of stroke
- lower limb amputation
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 |
|---|---|---|
| Cognitive Behavioral TherapyCognitive behavioral therapy focuses on the unique needs of men. A culturally adapted CBT program will be administered to participants as it has demonstrated increased effectiveness for marginalized populations. Cognitive Behavioral Therapy (CBT) aligns well with these cultural needs due to its individualized approach, non-judgmental stance, collaborative nature, and emphasis on empowerment through skills building. | Behavioural | Control Group, Intervention Group |
| ExerciseResearch demonstrates a preference for physical activity interventions among men with chronic illnesses, while highlighting limited access to fitness facilities in low-income urban areas as a barrier to participation. Online physical activity interventions have shown efficacy and cost-effectiveness in improving health behaviors, with virtual exercise programs for low-income African American populations demonstrating significant reductions in depressive symptoms. Therefore participants will receive exercise to help improve their diabetes self-management behaviors and depressive symptoms. | Behavioural | Intervention Group |
| Group Discussions - Ongoing SupportParticipants will join group discussions that will serve as on-going support. The small group component is designed to foster self-efficacy, autonomous motivation, and enjoyment by integrating skills building, personal values, spirituality, and goal setting. This approach has shown positive outcomes in previous pilot studies with African American men, serving as a source of vicarious learning and social support. | Behavioural | Intervention Group |
Primary outcome
Change in A1C
Time frame: Screening, Baseline, 10 weeks, 18 weeks, 30 weeks
Anthropometric/clinical data
Change in General Quality of Life (12-Item Short Form Survey (SF-12))
Time frame: Baseline, 10 weeks, 18 weeks, 30 weeks
Survey Data - 12 questions covering physical and mental health domains - Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Change in Diabetes-Related Distress (The Type 2 Diabetes Distress Assessment System)
Time frame: Baseline, 10 weeks, 18 weeks, 30 weeks
Survey Data - The assessment system has two components: The Core Distress Scale and The Sources Scale. The CORE DISTRESS SCORE is simply the average of the 8 items of the CORE SCALE, with each item rated on a 1 to 5 scale: Mean score < 2.0 indicate little or no distress, Mean score between 2.0 and 2.9 indicate moderate distress, Mean score > 3.0 indicate high distress. The Sources scale aims to find the sources of the distress, whether CORE DISTRESS is high or low, it is helpful to identify those aspects of living with diabetes that are contributing to the individual's diabetes distress.
Change in Diabetes Quality of Life (Diabetes Quality of Life Instrument)
Time frame: Baseline, 10 weeks, 18 weeks, 30 weeks
Survey Data - Survey answers range for each section of the survey asking about satisfaction, worry, and impact of diabetes. The DQoL measure consists of 46 items ranked on a 5-point Likert scale. Individual domain and DQoL total scores range from 0 (lowest possible QoL) to 100 (highest possible QoL).
1 secondary outcome
Change in Diabetes Self-Efficacy (Perceived Diabetes Self-Management Scale)
Time frame: Baseline, 10 weeks, 18 weeks, 30 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 9 Oct 2026.
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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.
Jaclynn Hawkins, PhD principal investigator
University of Michigan, School of Social Work
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy, Exercise and Group Discussions - Ongoing Support in people with Diabetes Mellitus, Type 2 and Depressive Symptoms, run by University of Michigan at 1 site 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 9 inclusion and 24 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in A1C (time frame: Screening, Baseline, 10 weeks, 18 weeks, 30 weeks). The study lists 4 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 9 Oct 2026.