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Type 2 DiabetesIDOLcNCT01665989

Improving Diabetes Outcomes Through Lifestyle Change (IDOLc)Study

A study testing Group Lifestyle Program in people with Type 2 Diabetes and Obesity, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes, Obesity
What is being tested?
Group Lifestyle Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteUnited States
Study dates
Aug 2012to Jan 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Diabetes Research Center - Massachusetts General Hospiral

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Improving Diabetes Outcomes Through Lifestyle Change (IDOLc) Translation Study

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.
Read more

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.

Being tested
Group Lifestyle Program, Usual Care
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group Lifestyle ProgramBehavioural

  • Usual CareBehavioural

    Visits with a dietitian at nutrition services at MGH

Study groups in NCT01665989
Study groupRoleWhat they receive
Group Lifestyle programExperimentalThe 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.
Receives: Behavioral: Group Lifestyle Program
Usual CareActive comparatorA 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.
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline and 6 months

Secondary outcomes (9)

  1. HbA1c

    Measured: baseline and 6 months

  2. Lipids

    Total cholesterol, LDL cholesterol, HDL-cholesterol and triglyceride levels will be measured with standard methods.

    Measured: baseline and 6 months

  3. Blood Pressure

    Resting blood pressure will be measured in duplicate using an automated device.

    Measured: baseline and 6 months

  4. 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

    Measured: baseline and 6 months

  5. 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.

    Measured: baseline and 6 months

  6. 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).

    Measured: baseline and 6 months

  7. 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.

    Measured: baseline and 6 months

  8. 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.

    Measured: baseline and 6 months

  9. 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.

    Measured: baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01665989
Sponsor's protocol ID
2012P000824
Acronym
IDOLc
Status last verified
Sep 2015
First submitted
10 Aug 2012
Last updated
25 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26260043

Questions about this trial

What is this clinical trial studying?

A study testing Group Lifestyle Program in people with Type 2 Diabetes and Obesity, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in weight (percent weight loss from baseline to 6 months) (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01665989, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.

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