Trial Outcomes & Findings for Michigan Men's Diabetes Project 2 (NCT NCT05370781)

Michigan Men's Diabetes Project 2

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.

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.

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.

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.

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.

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.

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.

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.

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.