Weight Loss Study for People With Type 2 Diabetes
T2D
Effects on Glycemic Control and Weight of a Modified Commercial Weight Control Program for People With Type 2 Diabetes
1 other identifier
interventional
563
1 country
15
Brief Summary
The purpose of this study is to determine whether the Weight Watchers program modified for use by people with Type 2 diabetes results in more improvements in blood glucose control relative to a control group receiving standard diabetes counseling.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes
Started May 2012
Typical duration for phase_3 type-2-diabetes
15 active sites
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
First Submitted
Initial submission to the registry
April 27, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedFirst Posted
Study publicly available on registry
May 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedOctober 15, 2014
March 1, 2012
2 years
April 27, 2012
October 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
Baseline and 12 months
Secondary Outcomes (8)
Secondary Endpoints
Baseline and 12 months
Secondary Endpoints
Baseline and 12 months
Secondary Endpoints
Baseline and 12 months
Secondary Endpoints
Baseline and 12 months
Secondary Endpoints
Baseline and 12 months
- +3 more secondary outcomes
Study Arms (2)
Modified Weight Watchers program
EXPERIMENTALStandard Diabetes Counseling group
ACTIVE COMPARATORInterventions
Weight Watchers: For people with Type 2 diabetes including (1) weekly standard in-person Weight Watchers meetings, (2) use of the standard Weight Watchers online program and tools, and (3) two scheduled telephone consultations with a Certified Diabetes Educator (CDE) who will assist the participant in tailoring the standard Weight Watchers program to accommodate the participant's diabetes-related status, with additional unlimited phone and email access to CDEs at the participant's request
One session of in-person diabetic nutritional counseling with a registered dietitian, with follow-up written educational materials.
Eligibility Criteria
You may qualify if:
- Participant reported diagnosis of Type II diabetes
- HbA1c between 7%-11% (inclusive)
- BMI 27-50 kg/m2 (inclusive)
- Age range - 18 - 70 (inclusive)
- Clearance on medical exam by study physician including EKG
- No weight loss over the previous 3 months (5kg loss is acceptable with physician discretion)
- On stable regimen of all medications (including diabetes) for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted)
- All diabetes medications are permitted including insulin.
- Willing and able to commit to regular physical activity (e.g. walking) five days per week
- Willingness and ability to make all scheduled appointments required by study protocol
- Willingness to attend weekly Weight Watchers meetings in the community and to participate in Weight Watchers online program, if so randomized
- Willing to follow requirements of study protocol
- Willing and able to provide a valid email address for use in the study
- Must be able to communicate (oral and written) in English
- Under the care of a physician for diabetes and willing to give release to contact the MD and request MD's agreement for participant to participate -
You may not qualify if:
- Type 1 Diabetes
- Cardiovascular/Coronary Heart Disease \[e.g., MI or CVA within last 6 months, TIA, clinically significant arrhythmias, uncontrolled hypertension (defined as blood pressure over 160/110); physician's discretion may be more conservative\]
- Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode
- Taking prescription or OTC weight loss medications within last 4 weeks
- Currently taking other medications that affect weight (e.g., paroxetine, tricyclics, anti-psychotics)
- Within the last 4 weeks, use of chromium supplements or any nutrition supplements or herbal products claimed to have a weight loss effect. Participants using other non-excluded nutrition supplements or herbal products must agree to continue at their current level of use throughout the study.
- Participation in a weight control program within the past 3 months
- QTc interval \>450 msec for males and QTc interval \>470 msec for females
- PHQ-9 total score \> 15
- Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable
- History of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve)
- History of major surgery within three months of enrollment
- Presence of implanted cardiac defibrillator
- Orthopedic limitations that would interfere with ability to engage in regular physical activity
- Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of South Carolinalead
- WW International Inccollaborator
Study Sites (15)
Diabetes Research and Training Center, University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Scripps Clinical Research
La Jolla, California, 92037, United States
CSRA Partners in Health
Augusta, Georgia, 30909-6599, United States
Northwestern University Feinberg School
Chicago, Illinois, 60611, United States
Obesity Research Center St. Luke's Roosevelt Hospital Center
New York, New York, 10025, United States
Weill Medical College of Cornell University
New York, New York, 10065, United States
Center for Nutrition and Preventive Medicine
Charlotte, North Carolina, 28277, United States
Obesity Clinical Trials Program Duke University Medical Center
Durham, North Carolina, 27710, United States
Your Diabetes Endocrine Nutrition Group Inc.
Mentor, Ohio, 44060, United States
Oregon Weight Loss Surgery, LLC
Portland, Oregon, 97210, United States
The University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baylor Endocrine Center
Dallas, Texas, 75246-1906, United States
Oakwell Clinical Research
San Antonio, Texas, 78218, United States
Washington Center for Weight Management & Research, Inc The Navy League Building
Arlington, Virginia, 22201, United States
Related Publications (1)
O'Neil PM, Miller-Kovach K, Tuerk PW, Becker LE, Wadden TA, Fujioka K, Hollander PL, Kushner RF, Timothy Garvey W, Rubino DM, Malcolm RJ, Weiss D, Raum WJ, Salyer JL, Hermayer KL, Rost SL, Veliko JL, Sora ND. Randomized controlled trial of a nationally available weight control program tailored for adults with type 2 diabetes. Obesity (Silver Spring). 2016 Nov;24(11):2269-2277. doi: 10.1002/oby.21616.
PMID: 27804264DERIVED
Related Links
- The University of Pennsylvania Center for Weight and Eating Disorders
- Medical University of South Carolina
- Obesity Clinical Trials Program Duke University Medical Center
- Comprehensive Weight Control Program Weill Medical College of Cornell University
- Oregon Weight Loss Surgery, LLC
- Scripps Nutrition and Metabolic \& Research
- University of Alabama at Birmingham Department of Nutrition
- The Washington Center for Weight Management \& Research
- Baylor Research
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Patrick M. O'Neil, PhD
Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2012
First Posted
May 18, 2012
Study Start
May 1, 2012
Primary Completion
May 1, 2014
Study Completion
September 1, 2014
Last Updated
October 15, 2014
Record last verified: 2012-03