Improving Diabetes Outcomes Through Lifestyle Change (IDOLc)Study (IDOLc)
Type 2 Diabetes, Obesity
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Diabetes Research Center - Massachusetts General Hospiral
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group Lifestyle program
Usual Care
The group lifestyle program used in the IDOLc study is adapted from the first 6 months of the Look AHEAD program and will include 19 group sessions offered over a six month period. Each of 2 groups will contain up to 15 patients with type 2 diabetes and will last 1-1.5 hours. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. The program fosters the development of knowledge and lifestyle skills to change diet and exercise habits through use of goal setting, problem solving, stimulus control and other behavioral techniques that have resulted in weight loss, weight maintenance and improved glycemic control.
A research assistant will provide the usual care group participants with brief (~15-20 minutes) counseling which reviews an educational handout emphasizing that modest weight loss (5 - 10%) via caloric restriction and gradual adoption of moderate increases in daily physical activity (equivalent to brisk walking for 30 minutes daily) is safe and effective in managing diabetes; and refer them to Nutrition Services for follow up.