Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Официальное название

Michigan Men's Diabetes Project 3 (MenD 3): Mind and Motion

Обзор

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.

Вмешательства

• Поведенческое Cognitive Behavioral Therapy
  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.
• Поведенческое Exercise
  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 recei
• Поведенческое Group Discussions - Ongoing Support
  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.

Первичные конечные точки

• Change in A1C [Срок оценки: Screening, Baseline, 10 weeks, 18 weeks, 30 weeks]
• Change in General Quality of Life (12-Item Short Form Survey (SF-12)) [Срок оценки: Baseline, 10 weeks, 18 weeks, 30 weeks]
• Change in Diabetes-Related Distress (The Type 2 Diabetes Distress Assessment System) [Срок оценки: Baseline, 10 weeks, 18 weeks, 30 weeks]
• Change in Diabetes Quality of Life (Diabetes Quality of Life Instrument) [Срок оценки: Baseline, 10 weeks, 18 weeks, 30 weeks]

Вторичные конечные точки (1)

• Change in Diabetes Self-Efficacy (Perceived Diabetes Self-Management Scale) [Срок оценки: Baseline, 10 weeks, 18 weeks, 30 weeks]

Критерии участия

Критерии включения

• 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)
• 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

Критерии исключения

• 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
• 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!

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT06574035 · HUM00256519

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗