Type 2 Diabetes Clinical Trial
Official title:
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.
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