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Improving Diabetes Outcomes Through Lifestyle Change (IDOLc)Study

NCT01665989 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2015-09-25

No results posted yet for this study

Summary

This research project has two primary specific aims in the Partners HealthCare clinical population and setting:

1. To compare the effects of two interventions, a translation of the Look AHEAD lifestyle behavioral intervention program with usual care (UC) (brief nutrition counseling and referral to Nutrition Services, the current standard), on the primary outcome of weight loss and secondary outcomes of HbA1c, blood pressure, fasting lipid levels, and prescription medication (doses and costs) for diabetes and its related conditions.

We hypothesize that participants who receive the translation of the Look AHEAD program will lose significantly more weight and have lower glycemia, blood pressure, cholesterol, and drug doses and costs for these conditions than participants who receive UC.
2. To compare the effects of the two interventions on health behaviors, self-efficacy, diabetes-specific quality-of-life and patient satisfaction with quality of care.

We hypothesize that participants who receive the translation of the Look AHEAD program will be more satisfied with their care and will experience greater improvements in health behavior, self-efficacy, and diabetes-specific quality-of-life compared to participants who receive UC.

Secondary specific aim: To assess the cost-effectiveness of the two interventions and the potential cost savings in terms of reductions in medication doses. In the current environment, a cost effective approach to lifestyle change is imperative. The costs and benefits of the interventions in this project will be carefully analyzed.

Conditions

Interventions

BEHAVIORAL

Group Lifestyle Program

BEHAVIORAL

Usual Care

Visits with a dietitian at nutrition services at MGH

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Linda M Delahanty, M.S. R.D. · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01665989 on ClinicalTrials.gov