Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
563 participants
INTERVENTIONAL
2012-05-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Modified Weight Watchers program
Weight Watchers modified program
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
Standard Diabetes Counseling group
Standard Care group
One session of in-person diabetic nutritional counseling with a registered dietitian, with follow-up written educational materials.
Interventions
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Weight Watchers modified program
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
Standard Care group
One session of in-person diabetic nutritional counseling with a registered dietitian, with follow-up written educational materials.
Eligibility Criteria
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Inclusion Criteria
2. HbA1c between 7%-11% (inclusive)
4. BMI 27-50 kg/m2 (inclusive)
5. Age range - 18 - 70 (inclusive)
6. Clearance on medical exam by study physician including EKG
7. No weight loss over the previous 3 months (5kg loss is acceptable with physician discretion)
8. On stable regimen of all medications (including diabetes) for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted)
9. All diabetes medications are permitted including insulin.
10. Willing and able to commit to regular physical activity (e.g. walking) five days per week
11. Willingness and ability to make all scheduled appointments required by study protocol
12. Willingness to attend weekly Weight Watchers meetings in the community and to participate in Weight Watchers online program, if so randomized
13. Willing to follow requirements of study protocol
14. Willing and able to provide a valid email address for use in the study
15. Must be able to communicate (oral and written) in English
16. 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 -
Exclusion Criteria
2. Cardiovascular/Coronary Heart Disease \[e.g., MI or CVA within last 6 months, TIA, clinically significant arrhythmias, uncontrolled hypertension (defined as blood pressure over 160/110); physician's discretion may be more conservative\]
3. Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode
4. Taking prescription or OTC weight loss medications within last 4 weeks
5. Currently taking other medications that affect weight (e.g., paroxetine, tricyclics, anti-psychotics)
6. 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.
7. Participation in a weight control program within the past 3 months
8. QTc interval \>450 msec for males and QTc interval \>470 msec for females
9. PHQ-9 total score \> 15
10. 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
11. 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)
12. History of major surgery within three months of enrollment
13. Presence of implanted cardiac defibrillator
14. Orthopedic limitations that would interfere with ability to engage in regular physical activity
15. Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease
16. Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Persons with successfully resected basal cell carcinoma of the skin may be enrolled if treatment was completed more than 6 months prior to enrollment.
17. History, within the past five years, of clinically diagnosed eating disorders Confidential March 30, 2012 9 including anorexia nervosa or bulimia nervosa.
18. Women who are pregnant, lactating , trying to become pregnant or unwilling to use an effective means of birth control
19. Participation in another clinical trial within 30 days prior to enrollment.
20. Currently consuming \>14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to limit intake to less than 3 drinks per drinking day during study participation
21. Current or past drug abuse
22. Participation in trial by another member of household
23. Hypoglycemic Events:
a. Evidence of more than 1 severe hypoglycemic event in the past 12 months, unless the participant's treating physician provides written clearance for participation.
24. Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial -
18 Years
70 Years
ALL
No
Sponsors
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WW International Inc
INDUSTRY
Medical University of South Carolina
OTHER
Responsible Party
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Principal Investigators
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Patrick M. O'Neil, PhD
Role: STUDY_DIRECTOR
Medical University of South Carolina
Locations
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Diabetes Research and Training Center, University of Alabama at Birmingham
Birmingham, Alabama, United States
Scripps Clinical Research
La Jolla, California, United States
CSRA Partners in Health
Augusta, Georgia, United States
Northwestern University Feinberg School
Chicago, Illinois, United States
Obesity Research Center St. Luke's Roosevelt Hospital Center
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Center for Nutrition and Preventive Medicine
Charlotte, North Carolina, United States
Obesity Clinical Trials Program Duke University Medical Center
Durham, North Carolina, United States
Your Diabetes Endocrine Nutrition Group Inc.
Mentor, Ohio, United States
Oregon Weight Loss Surgery, LLC
Portland, Oregon, United States
The University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor Endocrine Center
Dallas, Texas, United States
Oakwell Clinical Research
San Antonio, Texas, United States
Washington Center for Weight Management & Research, Inc The Navy League Building
Arlington, Virginia, United States
Countries
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References
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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.
Related Links
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The University of Pennsylvania Center for Weight and Eating Disorders
Your Diabetes Endocrine Nutrition Group, Inc
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
Other Identifiers
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WW-MUSC-1201
Identifier Type: -
Identifier Source: org_study_id
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