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
|Condition or disease||Intervention/treatment||Phase|
|At-risk Drinking Type 2 Diabetes||Behavioral: Brief alcohol intervention Behavioral: General health education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Brief Alcohol Intervention to Reduce At-Risk Drinking Among Type 2 Diabetics|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||March 2017|
Experimental: Brief alcohol intervention
Brief alcohol intervention delivered in 2 15-minute in-person sessions and 2 5-minute telephone sessions.
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.
Active Comparator: General Health Education
General health education intervention delivered in 2 15-minute in-person sessions and 2 5-minute telephone sessions.
Behavioral: General health education
The intervention will consist of information about several general health behaviors.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950040
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Susan E Ramsey, Ph.D.||Rhode Island Hospital|