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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; At-risk Drinking
• Intervention / Treatment: Behavioral: Brief alcohol intervention; Behavioral: General health education

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of drinks per day	1, 3, 6, and 12 months
Percentage heavy drinking days	1, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Summary of Diabetes Self-Care Activities subscale scores	1, 3, 6, and 12 months
HbA1c levels	3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Investigators: Principal Investigator: Susan E Ramsey, Ph.D., Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: July 30, 2009
• First Submitted That Met QC Criteria: July 30, 2009
• First Posted (Estimate): July 31, 2009

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Treatment adherence; At-risk drinking; At-risk drinking among Type 2 diabetic patients
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: AA017418