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NCT Number: NCT05370781

Michigan Men's Diabetes Project 2

The Michigan Men's Diabetes Project 2 (MenD 2) is an 18-month pilot randomized clinical trial. We are looking to recruit 60 Black men with type 2 diabetes (need to have diagnosis for at least 6 months) that are over the age of 21. Interested participants need to be under the care of a physician for their diabetes, have access to reliable transportation for study activities, and be willing to participate in 4 health assessments where they will get their A1C, blood pressure, height, and weight measured and they will complete a survey. All participants will receive 10 hours of diabetes self-management education with a Certified Diabetes Care and Education Specialist. Participants randomized to the intervention arm will also be offered 6 months of monthly diabetes self-management support (DSMS) sessions with trained Peer Leaders who are also Black men with type 2 diabetes. After the 6 months of support, this group will transition into 6 months of ongoing support where they can continue DSMS and/or other diabetes related initiatives that are important to the group and chosen by the group. Due to the COVID-19 pandemic, DSME and DSMS sessions will likely be held via Zoom, ongoing support sessions have potential to be in person. The 4 health assessments will take place at baseline, 3-months, 9-months, and 15-months.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Black/African American males, age 21 years or older with diagnosis of T2D for six months, transportation to attend program activities, under the care of a physician for diabetes, and willing to attend group delivered sessions.

Exclusion criteria

  • We considered restricting eligibility to a higher-risk population of participants with A1c ≥ 8%. Preliminary data suggest that over 50% of the proposed study sample will have an A1c ≥ 8%. Focusing on all older Black men with T2D allows us to cast a wide net for secondary prevention and public health impact.

Treatment and study plan

Peer Led Diabetes Self-Management Support

Behavioral

While the effectiveness of peer-led interventions delivering diabetes-related education and support for short-term clinical, psychosocial, and behavioral improvements is well-established, older Black men in particular are less likely to participate and are at a higher risk of drop-out from these studies. This intervention aims to determine if using older Black men as peer leaders to other older Black men will improve retention rates for this population.

Diabetes Self-Management Education

Behavioral

Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom platform.

Primary outcomes

  1. Hemoglobin A1c

    Time frame: baseline, 3-months, 9-months, 15-months

    Anthropometric data/clinical data - Change in HbA1c. HbA1c was measured using the DCA 2000 point-of-care testing instrument. A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.

  2. Change in Diabetes Self-Management

    Time frame: baseline, 3-months, 9-months, 15-months

    Psychosocial survey data collection (self-reported). Diabetes self-management was measured using the 8-item Perceived Diabetes Self-Management Scale (PDSMS), with summed scores ranging from 8 to 40 and higher scores representing greater self-effectiveness. A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.

Secondary outcomes

  1. Change in BMI

    Time frame: baseline, 3-months, 9-months, 15-months

    Weight relative to height. A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.

  2. Change in Depression

    Time frame: baseline, 3-months, 9-months, 15-months

    Psychosocial survey data collection (self-reported). Patient Health Questionnaire (PHQ-9)

    o Sum Scores: The total score categorizes depression severity:

    • 0-4: Minimal or none
    • 5-9: Mild
    • 10-14: Moderate
    • 15-19: Moderately severe
    • 20-27: Severe

    A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.

  3. Change in Blood Pressure (Systolic)

    Time frame: baseline, 3-months, 9-months, 15-months

    Anthropometric data/clinical data - Change in Blood Pressure (systolic - mmHg). Blood pressure was measured using an automated machine that obtained three readings with 1 min between each reading. The readings were averaged and recorded. A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.

  4. Change in Blood Pressure (Diastolic)

    Time frame: baseline, 3-months, 9-months, 15-months

    Anthropometric data/clinical data - Change in Blood Pressure (diastolic - mmHg). Blood pressure was measured using an automated machine that obtained three readings with 1 min between each reading. The readings were averaged and recorded. A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.

  5. Change in Diabetes Social Support

    Time frame: baseline, 3-months, 9-months, 15-months

    To measure perceived social support, the 8-item Social Support Questionnaire (Duke-UNC Functional Social Support Questionnaire) was used. Responses are measured on a Likert scale from 1 ("Much less than I would like") to 5 ("As much as I would like"). The higher the score, the higher the level of perceived support. In the current study, response options ranged from 1 ("Much less than I would like") to 6 ("As much as I would like") across all eight items. Responses to the eight items were summed to produce a total score ranging from 8 to 48. Higher total scores indicate greater perceived social support.

  6. Change in Diabetes-Related Distress (Core)

    Time frame: baseline, 3-months, 9-months, 15-months

    To measure diabetes distress (emotional distress as a result of living with type 2 diabetes), the Type 2 Diabetes Distress Assessment System (T2-DDAS) was used. The Core Distress Score is the average of all eight items of the scale and is measured on a 1 to 5 Likert scale ("Not a Problem = 1" to "A Very Serious Problem = 5"). Higher scores indicate higher levels of distress. A mean score of <2.0 indicates little or no distress. A mean score ≥2.0 but not more than 2.9 indicates moderate distress. A mean score ≥3.0 indicates high distress. Any score >2.0 is considered clinically significant.

  7. Change in Conformity to Masculine Norms

    Time frame: baseline, 3-months, 9-months, 15-months

    The Short Form of the Conformity to Masculine Norms Inventory (CMNI-30) was used to assess conformity to traditional masculine norms. Participants rated the extent to which they agreed with 30 behavioral statements. Each item was scored on a 6-point scale ranging from 0 (strongly disagree) to 5 (strongly agree). Responses to all 30 items were summed to calculate a total score ranging from 0 to 150. Higher total scores indicate stronger adherence to traditional masculine norms.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: MenD 2

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 12, 2022
Registry last updated
Aug 7, 2026

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.

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