Improving Diabetes Outcomes Through Lifestyle Change (IDOLc) Translation Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Change in weight (percent weight loss from baseline to 6 months)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This research project has two primary specific aims in the Partners HealthCare clinical population and setting:
-
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.
-
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.
Investigators
Linda M. Delahanty
Clinical Research Program/Project Manager
Massachusetts General Hospital
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
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
Outcomes
Primary Outcomes
Change in weight (percent weight loss from baseline to 6 months)
Time Frame: baseline and 6 months
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.
Secondary Outcomes
- Diabetes Specific Quality-of-Life(baseline and 6 months)
- Medication Prescriptions(baseline and 6 months)
- Health behaviors(baseline and 6 months)
- Satisfaction with Care(baseline and 6 months)
- Lipids(baseline and 6 months)
- Blood Pressure(baseline and 6 months)
- Self-efficacy(baseline and 6 months)
- Cost effectiveness and savings(baseline and 6 months)
- HbA1c(baseline and 6 months)