Improving Diabetes Outcomes Through Lifestyle Change (IDOLc)Study

Completed · Not applicable

Conditions studied: Type 2 Diabetes, Obesity

In brief

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.

Key facts

Study ID

NCT01665989

Run by

Massachusetts General Hospital

People needed

57

Starts

2012-08-01

Expected to finish

2014-01-01

Last updated by the study team

2015-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of type 2 diabetes
• Age 18 years or older
• Overweight or obese (BMI > 25)
• HbA1c level 7.5-< 11%
• Systolic blood pressure (SBP) < 160 mmHg, diastolic blood pressure (DBP) < 100 mmHg
• Triglyceride levels < 600 mg/dL
• Be on at least one non-metformin diabetes medication
• If taking medication for a chronic disease such as hypothyroidism, must be on a stable dose for the previous 6 months
• Willing to lose 5-7% of body weight
• Willing to increase activity to at least 175 minutes/week
• Willing to commit to random assignment to either attend and participate in the 19-week lifestyle change program or be referred to Nutrition Services for usual care
• Stable health, with no severe medical comorbidities that might interfere with their ability to participate in an intervention that includes increasing activity or decreasing calories, such as severe psychiatric illness or significant heart disease
• Have a primary care physician at Partners HealthCare
• Be able to understand and communicate effectively in English
• Have a blood glucose meter to self monitor blood glucose
• Be willing to keep a food, exercise and blood glucose diary

You may not qualify if…

• Must not be on Byetta (exenatide), Victoza (liraglutide), Bydureon (exenatide extended release), or Symlin (pramlintide)
• Must not be pregnant or planning pregnancy in the next year
• Must not be currently seeing a dietitian or participating in a weight loss program
• Must not have had a weight change of more than 5 pounds in the previous 3 months

Where it is running

• Diabetes Research Center - Massachusetts General Hospiral — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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