Ignite Creation Date:
2024-05-05 @ 10:59 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01227473
Status:
COMPLETED
Last Update Posted:
2012-06-15
First Post:
2010-04-15
Brief Title:
We Can Prevent Diabetes A Behavioral Intervention to Reduce Diabetes Risk in African Americans
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
A Mindfulness-based Intervention to Reduce Diabetes Risk in Pre-diabetic African Americans
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 US 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 US 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21AT004276-01A | OTHER | None | None |
| 1R21AT004276-01 | NIH | NIH NCCAM | httpsreporternihgovquickSearch1R21AT004276-01 |