Clinical trial NCT01665989: Improving Diabetes Outcomes Through Lifestyle Change (IDOLc)Study
Official title: Improving Diabetes Outcomes Through Lifestyle Change (IDOLc) Translation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Obesity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Change in weight (percent weight loss from baseline to 6 months)
timeFrame: baseline and 6 months
Secondary outcomes:
measure: HbA1c
timeFrame: baseline and 6 months
measure: Lipids
timeFrame: baseline and 6 months
measure: Blood Pressure
timeFrame: baseline and 6 months
measure: Medication Prescriptions
timeFrame: baseline and 6 months
measure: Health behaviors
timeFrame: baseline and 6 months
measure: Self-efficacy
timeFrame: baseline and 6 months
measure: Diabetes Specific Quality-of-Life
timeFrame: baseline and 6 months
measure: Satisfaction with Care
timeFrame: baseline and 6 months
measure: Cost effectiveness and savings
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Diabetes Research Center - Massachusetts General Hospiral
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Linda M Delahanty, M.S. R.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Delahanty LM, Dalton KM, Porneala B, Chang Y, Goldman VM, Levy D, Nathan DM, Wexler DJ. Improving diabetes outcomes through lifestyle change--A randomized controlled trial. Obesity (Silver Spring). 2015 Sep;23(9):1792-9. doi: 10.1002/oby.21172. Epub 2015 Aug 11.