Clinical trial NCT00950040: Brief Alcohol Intervention to Reduce At-Risk Drinking Among Type 2 Diabetics
Official title: Brief Alcohol Intervention to Reduce At-Risk Drinking Among Type 2 Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: At-risk Drinking
Type 2 Diabetes
Keywords: At-risk drinking
Type 2 diabetes
Treatment adherence
At-risk drinking among Type 2 diabetic patients
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2009-07-31
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of drinks per day
timeFrame: 1, 3, 6, and 12 months
measure: Percentage heavy drinking days
timeFrame: 1, 3, 6, and 12 months
Secondary outcomes:
measure: Summary of Diabetes Self-Care Activities subscale scores
timeFrame: 1, 3, 6, and 12 months
measure: HbA1c levels
timeFrame: 3, 6, and 12 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Susan E Ramsey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: