We Can Prevent Diabetes: A Behavioral Intervention to Reduce Diabetes Risk in African Americans

Completed · Phase 1/Phase 2

Conditions studied: Prediabetes

In brief

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.

Key facts

Study ID

NCT01227473

Run by

University of North Carolina, Chapel Hill

People needed

74

Starts

2010-02-01

Expected to finish

2012-05-01

Last updated by the study team

2012-06-15

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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