Overview

This trial is active, not recruiting.

Conditions type 2 diabetes, overweight, obesity
Treatments weight watchers modified program, standard care group
Phase phase 3
Sponsor Medical University of South Carolina
Collaborator Weight Watchers International
Start date May 2012
End date April 2013
Trial size 560 participants
Trial identifier NCT01601574, WW-MUSC-1201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
(Active Comparator)
standard care group
One session of in-person diabetic nutritional counseling with a registered dietitian, with follow-up written educational materials.

Primary Outcomes

Measure
Change in HbA1c
time frame: Baseline and 12 months

Secondary Outcomes

Measure
Secondary Endpoints
time frame: Baseline and 12 months
Secondary Endpoints
time frame: Baseline and 12 months
Secondary Endpoints
time frame: Baseline and 12 months
Secondary Endpoints
time frame: Baseline and 12 months
Secondary Endpoints
time frame: Baseline and 12 months
Secondary Endpoints
time frame: Baseline and 12 months
Secondary Endpoints
time frame: Baseline and 12 months
Secondary Endpoints
time frame: Baseline and 12 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: 1. Participant reported diagnosis of Type II diabetes 2. HbA1c between 7%‐11% (inclusive) 3. 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. 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: 1. Type 1 Diabetes 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 -

Additional Information

Official title Effects on Glycemic Control and Weight of a Modified Commercial Weight Control Program for People With Type 2 Diabetes
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Medical University of South Carolina.