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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00950040
Acronym
SUGAR
Enrollment
92
Registered
2009-07-31
Start date
2009-07-31
Completion date
2017-03-31
Last updated
2017-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

At-risk Drinking, Type 2 Diabetes

Keywords

At-risk drinking, Type 2 diabetes, Treatment adherence, At-risk drinking among Type 2 diabetic patients

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.

Interventions

BEHAVIORALGeneral health education

The intervention will consist of information about several general health behaviors.

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.

Sponsors

Rhode Island Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Number of drinks per day1, 3, 6, and 12 months
Percentage heavy drinking days1, 3, 6, and 12 months

Secondary

MeasureTime frame
Summary of Diabetes Self-Care Activities subscale scores1, 3, 6, and 12 months
HbA1c levels3, 6, and 12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026