Improving Diabetes Outcomes Through Lifestyle Change (IDOLc)Study
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.
Type 2 Diabetes
Behavioral: Group Lifestyle Program
Behavioral: Usual Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Improving Diabetes Outcomes Through Lifestyle Change (IDOLc) Translation Study|
- Change in weight (percent weight loss from baseline to 6 months) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]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.
- HbA1c [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
- Lipids [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]Total cholesterol, LDL cholesterol, HDL-cholesterol and triglyceride levels will be measured with standard methods.
- Blood Pressure [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]Resting blood pressure will be measured in duplicate using an automated device.
- Medication Prescriptions [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]Prescription medications (doses and costs) for diabetes, blood pressure and lipids will be recorded at the initial visit before intervention and 6 months later at the final research visit once the intervention is completed
- Health behaviors [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]Dietary behavior will be assessed using the Fat-Related Diet Questionnaire and the Restraint Subscale of the Dutch Eating Behavior Questionnaire; activity behavior will be assessed by the Global Physical Activity Questionnaire (GPAC), and self reported minutes of activity.
- Self-efficacy [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]Changes in self-efficacy will be measured using the Diet Self-efficacy Scale, a 16-item scale that measures confidence in one's ability to adopt healthy dietary behaviors and the Exercise Self-Efficacy scale, a 5-item scale that measures confidence (7-point scale) in one's ability to persist with exercise in situations that involve potential barriers, e.g., negative affect and time constraints).
- Diabetes Specific Quality-of-Life [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]Diabetes specific quality-of-life will be measured using the Problem Areas In Diabetes (PAID) scale, a 20-item self-report measure of diabetes-related emotional distress that has shown high internal reliability, sensitivity to change and clinical utility.
- Satisfaction with Care [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]Patient satisfaction and impact surveys have been adapted for pertinence from the Diabetes Quality of Life Measure (DQOL) will be administered. In addition, subjects will be asked questions at the end of the 6 month intervention period to rate their level of satisfaction with their interactions during the visits with the dietitian.
- Cost effectiveness and savings [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]We will prospectively track the different categories of possible costs (wages for interventionists, rent, intervention materials, phone bills, postage, photocopies and unforeseen expenses). We will track changes in medications made by the provider during and after completion of the intervention and calculate any associated changes in costs by intervention group. We will also record medication and nutrition and medical visit costs of usual care in the control group.
|Study Start Date:||August 2012|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Group Lifestyle program
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.
|Behavioral: Group Lifestyle Program|
Active Comparator: Usual Care
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.
Behavioral: Usual Care
Visits with a dietitian at nutrition services at MGH
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665989
|Contact: Hilary M Dulin, B.S.||firstname.lastname@example.org|
|United States, Massachusetts|
|Diabetes Research Center - Massachusetts General Hospiral||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator: Linda M Delahanty, M.S. R.D.|
|Principal Investigator:||Linda M Delahanty, M.S. R.D.||Massachusetts General Hospital|