NCT00950040

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2009

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2016

Enrollment Period

7.4 years

First QC Date

July 30, 2009

Last Update Submit

April 10, 2017

Conditions

At-risk DrinkingType 2 Diabetes

Keywords

At-risk drinkingType 2 diabetesTreatment adherenceAt-risk drinking among Type 2 diabetic patients

Outcome Measures

Primary Outcomes (2)

  • Number of drinks per day

    1, 3, 6, and 12 months

  • Percentage heavy drinking days

    1, 3, 6, and 12 months

Secondary Outcomes (2)

  • Summary of Diabetes Self-Care Activities subscale scores

    1, 3, 6, and 12 months

  • HbA1c levels

    3, 6, and 12 months

Study Arms (2)

Brief alcohol intervention

EXPERIMENTAL

Brief alcohol intervention delivered in 2 15-minute in-person sessions and 2 5-minute telephone sessions.

Behavioral: Brief alcohol intervention

General Health Education

ACTIVE COMPARATOR

General health education intervention delivered in 2 15-minute in-person sessions and 2 5-minute telephone sessions.

Behavioral: General health education

Interventions

Brief alcohol interventionBEHAVIORAL

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.

Brief alcohol intervention
General health educationBEHAVIORAL

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

General Health Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older,
  • have Type 2 diabetes,
  • report at-risk drinking in past month,
  • report poor diabetes treatment adherence.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Treatment Adherence and Compliance

Interventions

EthanolMethods

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsInvestigative Techniques

Study Officials

  • Susan E Ramsey, Ph.D.

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2009

First Posted

July 31, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

April 12, 2017

Record last verified: 2016-04

Locations

US(1)