Brief Alcohol Intervention to Reduce At-Risk Drinking Among Type 2 Diabetics (SUGAR)
Primary Purpose
At-risk Drinking, Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief alcohol intervention
General health education
Sponsored by

About this trial
This is an interventional treatment trial for At-risk Drinking focused on measuring At-risk drinking, Type 2 diabetes, Treatment adherence, At-risk drinking among Type 2 diabetic patients
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.
Sites / Locations
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Brief alcohol intervention
General Health Education
Arm Description
Brief alcohol intervention delivered in 2 15-minute in-person sessions and 2 5-minute telephone sessions.
General health education intervention delivered in 2 15-minute in-person sessions and 2 5-minute telephone sessions.
Outcomes
Primary Outcome Measures
Number of drinks per day
Percentage heavy drinking days
Secondary Outcome Measures
Summary of Diabetes Self-Care Activities subscale scores
HbA1c levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00950040
Brief Title
Brief Alcohol Intervention to Reduce At-Risk Drinking Among Type 2 Diabetics
Acronym
SUGAR
Official Title
Brief Alcohol Intervention to Reduce At-Risk Drinking Among Type 2 Diabetics
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
At-risk Drinking, Type 2 Diabetes
Keywords
At-risk drinking, Type 2 diabetes, Treatment adherence, At-risk drinking among Type 2 diabetic patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brief alcohol intervention
Arm Type
Experimental
Arm Description
Brief alcohol intervention delivered in 2 15-minute in-person sessions and 2 5-minute telephone sessions.
Arm Title
General Health Education
Arm Type
Active Comparator
Arm Description
General health education intervention delivered in 2 15-minute in-person sessions and 2 5-minute telephone sessions.
Intervention Type
Behavioral
Intervention Name(s)
Brief alcohol intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
General health education
Intervention Description
The intervention will consist of information about several general health behaviors.
Primary Outcome Measure Information:
Title
Number of drinks per day
Time Frame
1, 3, 6, and 12 months
Title
Percentage heavy drinking days
Time Frame
1, 3, 6, and 12 months
Secondary Outcome Measure Information:
Title
Summary of Diabetes Self-Care Activities subscale scores
Time Frame
1, 3, 6, and 12 months
Title
HbA1c levels
Time Frame
3, 6, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan E Ramsey, Ph.D.
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Brief Alcohol Intervention to Reduce At-Risk Drinking Among Type 2 Diabetics
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