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临床试验/NCT01227473
NCT01227473已完成1 期

A Mindfulness-based Intervention to Reduce Diabetes Risk in Pre-diabetic African Americans

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2010年2月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
74
试验地点
1
主要终点
insulin resistance, as measured by the homeostatic model assessment-insulin resistance (HOMA-IR)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •African-American
  • •25-65 years of age
  • •meeting the ADA criteria for pre-diabetes (either by fasting plasma glucose (FPG) of 100-125 mg/dl or glucose of 140-199 mg/dl at 2 hours in an oral glucose tolerance test (OGTT))or a HbA1c of 5.7-6.4%
  • •experiencing some degree of stress
  • •willing to attend 1 1/2 hour group meetings once weekly for 8 weeks, followed by monthly booster sessions for six months, and to complete assessment instruments.

排除标准

  • •diabetes diagnosed by a physician
  • •past or current use of hypoglycemic medication (except gestational diabetes)
  • •disease associated with disordered glucose metabolism
  • •use of medications associated with impaired glucose metabolism
  • •active treatment for or history of a major medical illness
  • •previous training in meditation or mindful yoga, tai chi, qigong
  • •pregnant or planning a pregnancy

研究组 & 干预措施

mindfulness prediabetes education group

Experimental

The mindfulness-based 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 mindfulness-based diabetes prevention group, the instruction will be enhanced with instruction in mindfulness.

干预措施: Mindfulness-based diabetes prevention education group (Behavioral)

conventional prediabetes education group

Active Comparator

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.

干预措施: Conventional diabetes prevention education group (Behavioral)

结局指标

主要结局

insulin resistance, as measured by the homeostatic model assessment-insulin resistance (HOMA-IR)

时间窗: Fasting samples will be collected 3 weeks, on average, before the intervention and at 3 months post intervention.

The homeostatic model assessment-insulin resistance (HOMA-IR) is a calculated measure based on the FPG and fasting insulin levels.

次要结局

  • Salivary cortisol(Salivary cortisol will be measured before the intervention and at 2 weeks, 3 months, and 6 months post intervention)
  • Insulin resistance as measured by the HOMA-IR(2 weeks and 6 months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Gaylord

Assistant Professor

University of North Carolina, Chapel Hill

研究点 (1)

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