We Can Prevent Diabetes: A Behavioral Intervention to Reduce Diabetes Risk in African Americans
Condition: Prediabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Pre-diabetes, characterized by glucose levels that are above normal but below the diagnostic
      criteria for diabetes, is an increasingly common condition, particularly among African
      Americans. Changes in physical activity, changes in diet, and levels of stress influence the
      course of the disease. Helping individuals to reduce stress and to increase healthy coping
      strategies may enhance conventional diabetes prevention efforts, especially among African
      Americans. Mindfulness training is a cost-effective intervention which may be effective in
      reducing stress and enhancing the ability to make behavioral changes. This exploratory pilot
      study will examine the potential efficacy of a diabetes prevention education program that
      includes training in mindfulness-based stress reduction (intervention group) for pre-diabetic
      African Americans, comparing it to a conventional diabetes prevention program (control group)
      in the ability to improve glucose metabolism as well as other relevant physiological and
      psychological secondary outcomes.
    

Detailed description: 
      Pre-diabetes, characterized by glucose levels that are above normal but below the diagnostic
      criteria for diabetes, is an increasingly common condition affecting approximately 54 million
      U.S. adults. African Americans are disproportionately affected by pre-diabetes and experience
      high rates of diabetes-associated morbidity and mortality including damage to the circulatory
      system, kidneys, and nervous system. Patients with pre-diabetes who increase their physical
      activity and improve their diets have reduced risk of developing diabetes. Psychological
      distress negatively influences the course of the disease by increasing deleterious health
      behaviors; preventing scheduling and maintenance of positive behavior change; and stimulating
      HPA-axis activation and dysregulation, which may have a direct impact on insulin resistance
      and glucose metabolism. African Americans may have increased exposure to stress and increased
      vulnerability to adverse stress-related health outcomes like diabetes, because of their
      unique history, sociocultural experiences, and societal position in the U.S. Helping
      individuals to reduce stress and to increase healthy coping strategies may enhance
      conventional diabetes prevention efforts, especially among African Americans.

      Mindfulness-based stress reduction (MBSR), a mind-body practice with a wide range of health
      benefits, has been shown to result in statistically significant reductions in psychological
      stress and anxiety in randomized, controlled studies. Mindfulness training is cost-effective
      in comparison with other small-group or individualized programs, and can be taught safely and
      effectively by well-trained instructors. There is little research, and no randomized,
      controlled trials of MBSR as a treatment for individuals with pre-diabetes. There is also
      little research on the acceptability of MBSR program to a prediabetic subgroup of African
      Americans, or on the acceptability of an MBSR program for a general population of African
      Americans.

      Overall goals of this exploratory pilot study are to study the potential efficacy of a
      diabetes prevention education program that includes training in mindfulness-based stress
      reduction for pre-diabetic African Americans. Specific Aims are 1) to determine the
      feasibility of developing a clinical trial to compare the effectiveness of a
      mindfulness-based diabetes prevention program (treatment group) with a conventional diabetes
      prevention program (control group) in improving glucose metabolism in pre-diabetic African
      American adults; 2) to identify relevant physiological and psychological secondary outcomes
      associated with a mindfulness-based, educational self-care program in African-Americans with
      pre-diabetes; 3) to assess the acceptability and cultural relevance of MBSR for pre-diabetic
      African Americans via a post-intervention qualitative study, to include interviews of
      participants, dropouts, and instructors; and 4) to identify, and find solutions for, problems
      in conducting a well-powered clinical trial to assess the efficacy of a mindfulness-based
      diabetes prevention program in improving glucose metabolism in pre-diabetic
      African-Americans.
    

Intervention name(s): Mindfulness-based diabetes prevention education group; Conventional diabetes prevention education group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The mindfulness-based diabetes prevention group meets for 2 ½ hours per week for eight weeks, with one 4-hour retreat between the 6th and 7th weeks, and monthly booster sessions for 6 months. During the 8-week interventions, this group receives a 30-minute health behavior presentation (based on the landmark Diabetes Prevention Program). In the mindfulness-based diabetes prevention group, the instruction will be enhanced with a modified mindfulness meditation training designed to support the behavioral-change programming.; The conventional diabetes prevention education group meets for 2 ½ hours per week for eight weeks, with one 4-hour retreat between the 6th and 7th weeks, and monthly booster sessions for 6 months. During the 8-week interventions, the group receives a 30-minute health behavior presentation (based on the landmark Diabetes Prevention Program). In the conventional diabetes prevention group, the instruction will be enhanced with group exercises and discussions.
Other intervention name(s): MBSR; DPP; DPP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: prediabetes; African Americans; mindfulness; behavioral; diabetes