Weight Loss Study for People With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Effects on Glycemic Control and Weight of a Modified Commercial Weight Control Program for People With Type 2 Diabetes

Conditions
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Type 2 Diabetes, Overweight, Obesity

Intervention / Treatment
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* Behavioral: Weight Watchers modified program
* Other: Standard Care group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant reported diagnosis of Type II diabetes HbA1c between 7%-11% (inclusive) Fasting blood glucose < 240. If a potential participant has a FBG above the inclusion criteria it is acceptable to re-test this potential participant within one week of the original test. 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 - 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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Weight Watchers program<br> | Behavioral: Weight Watchers modified program<br>* 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<br>|
| Active Comparator: Standard Diabetes Counseling group<br> | Other: Standard Care group<br>* One session of in-person diabetic nutritional counseling with a registered dietitian, with follow-up written educational materials.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoints | Change in weight | Baseline and 12 months | 
| Secondary Endpoints | Change in BMI | Baseline and 12 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, HbA1c, Overweight, Obesity