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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.
Primary Outcome
Weight will be measured in light street clothes (without shoes) to the nearest 0.1 kg using a digital research scale. Height will be measured using a stadiometer. BMI will be calculated.
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 |
What the finished NCT01665989 record still lists
NCT01665989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01665989's enrollment target sits among peer trials
57 688th of 1053 higher than 366 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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