NCT01665989

Brief Summary

This research project has two primary specific aims in the Partners HealthCare clinical population and setting:

  1. 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.
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

1.4 years

First QC Date

August 10, 2012

Last Update Submit

September 23, 2015

Conditions

Type 2 DiabetesObesity

Outcome Measures

Primary Outcomes (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.

    baseline and 6 months

Secondary Outcomes (9)

  • HbA1c

    baseline and 6 months

  • Lipids

    baseline and 6 months

  • Blood Pressure

    baseline and 6 months

  • Medication Prescriptions

    baseline and 6 months

  • Health behaviors

    baseline and 6 months

  • +4 more secondary outcomes

Study Arms (2)

Group Lifestyle program

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Group Lifestyle ProgramBEHAVIORAL
Group Lifestyle program
Usual CareBEHAVIORAL

Visits with a dietitian at nutrition services at MGH

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Research Center - Massachusetts General Hospiral

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 26260043DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Linda M Delahanty, M.S. R.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Program/Project Manager

Study Record Dates

First Submitted

August 10, 2012

First Posted

August 16, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

September 25, 2015

Record last verified: 2015-09

Locations

US(1)