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Brief Alcohol Intervention to Reduce At-Risk Drinking Among Type 2 Diabetics (SUGAR)

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ClinicalTrials.gov Identifier: NCT00950040
Recruitment Status : Completed
First Posted : July 31, 2009
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital

July 30, 2009
July 31, 2009
April 12, 2017
July 2009
December 2016   (Final data collection date for primary outcome measure)
  • Number of drinks per day [ Time Frame: 1, 3, 6, and 12 months ]
  • Percentage heavy drinking days [ Time Frame: 1, 3, 6, and 12 months ]
Same as current
Complete list of historical versions of study NCT00950040 on ClinicalTrials.gov Archive Site
  • Summary of Diabetes Self-Care Activities subscale scores [ Time Frame: 1, 3, 6, and 12 months ]
  • HbA1c levels [ Time Frame: 3, 6, and 12 months ]
Same as current
Not Provided
Not Provided
 
Brief Alcohol Intervention to Reduce At-Risk Drinking Among Type 2 Diabetics
Brief Alcohol Intervention to Reduce At-Risk Drinking Among Type 2 Diabetics
This study is designed to test an intervention to reduce at-risk drinking among Type 2 diabetic patients. At-risk drinking is associated with inferior diabetes treatment adherence and control. The investigators hypothesize that our brief alcohol intervention will result in a reduction in drinking and better diabetes treatment adherence and control. If successful, this intervention could help diabetics to gain better control of their diabetes and live healthier lives.

At-risk drinking is common among diabetic patients and is associated with inferior diabetes treatment adherence and outcomes. While methods for reducing alcohol use in this population have been largely unexplored to date, brief interventions to reduce at-risk drinking have been well-validated in other patient populations and offer the promise to reduce at-risk drinking among diabetic patients, resulting in improved diabetes treatment adherence and outcomes.

We hypothesize that adding a brief alcohol intervention to standard diabetes treatment, relative to general health education, will reduce overall drinking volume and heavy drinking days among diabetic patients who are at-risk drinkers.

Furthermore, we expect participants who receive the brief alcohol intervention to have better diabetes treatment adherence and outcomes than the participants receiving general health education. We also expect that reduced alcohol consumption will mediate the effect of the brief alcohol intervention on diabetes treatment adherence and outcomes. In addition, we will explore potential treatment mechanisms.

The proposed study is a randomized, two-group design with repeated measures over time, comparing a brief alcohol intervention plus standard diabetes treatment to general health education. For this study, we will recruit a sample of 240 Type 2 diabetic patients from a large, urban primary care clinic. To be eligible for the study, patients must report at-risk drinking and poor diabetes treatment adherence.

This study holds the promise of establishing an efficacious intervention approach for Type 2 diabetic patients who are at-risk drinkers and are likely to maintain poor diabetes treatment adherence and outcomes in the absence of a change in their drinking behavior, resulting in increased diabetes-related morbidity and mortality. The intervention proposed in this study represents a novel approach to reducing at-risk drinking among diabetic patients that, if efficacious, can be readily integrated into the treatment of diabetes in a variety of treatment settings. In addition, this study will provide valuable information regarding the relationship between alcohol use and diabetes treatment adherence and outcomes and about the mechanisms of change in alcohol use among Type 2 diabetic patients who are at-risk drinkers.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • At-risk Drinking
  • Type 2 Diabetes
  • Behavioral: Brief alcohol intervention
    The intervention consists of educational information, aspects of motivational interviewing, feedback concerning alcohol use and measures of glycemic control, alcohol use monitoring, and formulation of a change plan.
  • Behavioral: General health education
    The intervention will consist of information about several general health behaviors.
  • Experimental: Brief alcohol intervention
    Brief alcohol intervention delivered in 2 15-minute in-person sessions and 2 5-minute telephone sessions.
    Intervention: Behavioral: Brief alcohol intervention
  • Active Comparator: General Health Education
    General health education intervention delivered in 2 15-minute in-person sessions and 2 5-minute telephone sessions.
    Intervention: Behavioral: General health education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
240
March 2017
December 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years or older,
  • have Type 2 diabetes,
  • report at-risk drinking in past month,
  • report poor diabetes treatment adherence.

Exclusion Criteria:

  • current alcohol dependence or current psychoactive substance abuse or dependence (excluding nicotine),
  • currently psychotic,
  • unable to provide the name and contact information for a significant other to corroborate self-report,
  • unable to provide the name and contact information for two people who could serve as locators, do not have access to a telephone.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00950040
AA017418
Yes
Not Provided
Not Provided
Rhode Island Hospital
Rhode Island Hospital
Not Provided
Principal Investigator: Susan E Ramsey, Ph.D. Rhode Island Hospital
Rhode Island Hospital
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP