Improving Diabetes Outcomes Through Lifestyle Change (IDOLc)Study

Obesity Clinical Trial

— IDOLc  

Official title:

Improving Diabetes Outcomes Through Lifestyle Change (IDOLc) Translation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665989
• Other study ID #: 2012P000824
• Status: Completed
• Phase: N/A
• First received: August 10, 2012
• Last updated: September 23, 2015
• Start date: August 2012
• Est. completion date: January 2014

Study information

• Verified date: September 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Type 2 Diabetes

Intervention

Behavioral:
• Group Lifestyle Program

• Usual Care
Visits with a dietitian at nutrition services at MGH

Locations

Country	Name	City	State
United States	Diabetes Research Center - Massachusetts General Hospiral	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight (percent weight loss from baseline to 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.	baseline and 6 months	No
Secondary	HbA1c		baseline and 6 months	No
Secondary	Lipids	Total cholesterol, LDL cholesterol, HDL-cholesterol and triglyceride levels will be measured with standard methods.	baseline and 6 months	No
Secondary	Blood Pressure	Resting blood pressure will be measured in duplicate using an automated device.	baseline and 6 months	No
Secondary	Medication Prescriptions	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	baseline and 6 months	No
Secondary	Health behaviors	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.	baseline and 6 months	No
Secondary	Self-efficacy	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).	baseline and 6 months	No
Secondary	Diabetes Specific Quality-of-Life	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.	baseline and 6 months	No
Secondary	Satisfaction with Care	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.	baseline and 6 months	No
Secondary	Cost effectiveness and savings	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.	baseline and 6 months	No