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| Name | Class |
|---|---|
| WW International Inc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Weight Watchers program | Experimental |
| |
| Standard Diabetes Counseling group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Watchers modified program | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoints | Change in weight | Baseline and 12 months |
| Secondary Endpoints | Change in BMI | Baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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
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.
History, within the past five years, of clinically diagnosed eating disorders Confidential March 30, 2012 9 including anorexia nervosa or bulimia nervosa.
Women who are pregnant, lactating , trying to become pregnant or unwilling to use an effective means of birth control
Participation in another clinical trial within 30 days prior to enrollment.
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
Current or past drug abuse
Participation in trial by another member of household
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.
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 -
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| Name | Affiliation | Role |
|---|---|---|
| Patrick M. O'Neil, PhD | Medical University of South Carolina | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Research and Training Center, University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27804264 | Derived | 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. |
| Label | URL |
|---|---|
| The University of Pennsylvania Center for Weight and Eating Disorders | View source |
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|
| Standard Care group | Other | One session of in-person diabetic nutritional counseling with a registered dietitian, with follow-up written educational materials. |
|
| Secondary Endpoints | Change in waist circumference | Baseline and 12 months |
| Secondary Endpoints | Change in fasting blood glucose | Baseline and 12 months |
| Secondary Endpoints | Change in HOMA | Baseline and 12 months |
| Secondary Endpoints | Change in cardiovascular risk markers (lipid measures, blood pressure, C-Reactive Protein) | Baseline and 12 months |
| Secondary Endpoints | Change in diabetes medications. | Baseline and 12 months |
| Secondary Endpoints | Change in various mental health assessments | Baseline and 12 months |
| 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 |
| Medical University of South Carolina | View source |
| Obesity Clinical Trials Program Duke University Medical Center | View source |
| Oregon Weight Loss Surgery, LLC | View source |
| Scripps Nutrition and Metabolic \& Research | View source |
| University of Alabama at Birmingham Department of Nutrition | View source |
| The Washington Center for Weight Management \& Research | View source |
| Baylor Research | View source |
| Oakwell Clinical Research | View source |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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