Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
BEHAVIORALPeer Led Diabetes Self-Management Support
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.
BEHAVIORALDiabetes Self-Management Education
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.
Sponsors
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 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. |
| Change in Diabetes Self-Management | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI | 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. |
| Change in Depression | 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. |
| Change in Blood Pressure (Systolic) | 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. |
| Change in Blood Pressure (Diastolic) | 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. |
| Change in Diabetes Social Support | 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. |
| Change in Diabetes-Related Distress (Core) | 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. |
| Change in Conformity to Masculine Norms | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJaclynn Hawkins, PhD
University of Michigan, School of Social Work
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.1 Years STANDARD_DEVIATION 9.6 |
| Hemoglobin A1c | 6.5 % STANDARD_DEVIATION 0.8 |
| Race/Ethnicity, Customized Black | 3 Participants |
| Region of Enrollment United States | 24 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
None listed