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NCT01665989 · ClinicalTrials.gov registry record · NA
Improving Diabetes Outcomes Through Lifestyle Change (IDOLc)Study
A NA study of Obesity and Type 2 Diabetes, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT01665989: Completed NA study of Obesity and Type 2 Diabetes, sponsored by Massachusetts General Hospital.
NCT01665989 is a NA study of Obesity and Type 2 Diabetes that has completed, run by Massachusetts General Hospital. The registered enrollment target is 57 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01665989, a NA study of Obesity and Type 2 Diabetes, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- BEHAVIORAL Usual Care
- BEHAVIORAL Group Lifestyle Program
Study Locations (1)
Massachusetts
- Diabetes Research Center - Massachusetts General Hospiral - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01665989
The ClinicalTrials.gov registry entry for NCT01665989 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.
NCT01665989 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01665989 about?
NCT01665989 is a clinical study titled "Improving Diabetes Outcomes Through Lifestyle Change (IDOLc)Study". 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 ...
What is the current status of trial NCT01665989?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2012-08. Estimated completion is 2014-01.
What conditions does trial NCT01665989 study?
This clinical trial studies the following conditions: Obesity, Type 2 Diabetes.
What interventions are being tested in trial NCT01665989?
The interventions under investigation include: Usual Care (BEHAVIORAL), Group Lifestyle Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT01665989?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01665989 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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