We Can Prevent Diabetes: A Behavioral Intervention to Reduce Diabetes Risk in African Americans
A Mindfulness-based Intervention to Reduce Diabetes Risk in Pre-diabetic African Americans
3 other identifiers
interventional
74
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2010
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 15, 2010
CompletedFirst Posted
Study publicly available on registry
October 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJune 15, 2012
June 1, 2012
2 years
April 15, 2010
June 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
insulin resistance, as measured by the homeostatic model assessment-insulin resistance (HOMA-IR)
The homeostatic model assessment-insulin resistance (HOMA-IR) is a calculated measure based on the FPG and fasting insulin levels.
Fasting samples will be collected 3 weeks, on average, before the intervention and at 3 months post intervention.
Secondary Outcomes (2)
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
Study Arms (2)
mindfulness prediabetes education group
EXPERIMENTALThe 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.
conventional prediabetes education group
ACTIVE COMPARATORThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- African-American
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Susan Gaylord, PhD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 15, 2010
First Posted
October 25, 2010
Study Start
February 1, 2010
Primary Completion
February 1, 2012
Study Completion
May 1, 2012
Last Updated
June 15, 2012
Record last verified: 2012-06