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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Rhode Island Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00950040
First received: July 30, 2009
Last updated: July 19, 2011
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
At-risk Drinking
Type 2 Diabetes
Behavioral: Brief alcohol intervention
Behavioral: General health education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brief Alcohol Intervention to Reduce At-Risk Drinking Among Type 2 Diabetics

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Number of drinks per day [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Percentage heavy drinking days [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Summary of Diabetes Self-Care Activities subscale scores [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • HbA1c levels [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: July 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950040

Contacts
Contact: Susan E Ramsey, Ph.D. 4014447831 sramsey@lifespan.org

Locations
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Susan E Ramsey, Ph.D.    401-444-7831    sramsey@lifespan.org   
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Susan E Ramsey, Ph.D. Rhode Island Hospital
  More Information

No publications provided

Responsible Party: Susan E. Ramsey, Ph.D., Principal Investigator, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00950040     History of Changes
Other Study ID Numbers: AA017418
Study First Received: July 30, 2009
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
At-risk drinking
Type 2 diabetes
Treatment adherence
At-risk drinking among Type 2 diabetic patients

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014