Obesity Clinical Trial
Official title:
Improving Diabetes Outcomes Through Lifestyle Change (IDOLc) Translation 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 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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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