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Weight Loss Study for People With Type 2 Diabetes (T2D)

This study has been completed.
Sponsor:
Collaborator:
Weight Watchers International
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01601574
First received: April 27, 2012
Last updated: October 14, 2014
Last verified: March 2012

April 27, 2012
October 14, 2014
May 2012
May 2014   (final data collection date for primary outcome measure)
Change in HbA1c [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01601574 on ClinicalTrials.gov Archive Site
  • Secondary Endpoints [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Change in weight
  • Secondary Endpoints [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Change in BMI
  • Secondary Endpoints [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Change in waist circumference
  • Secondary Endpoints [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Change in fasting blood glucose
  • Secondary Endpoints [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Change in HOMA
  • Secondary Endpoints [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Change in cardiovascular risk markers (lipid measures, blood pressure, C-Reactive Protein)
  • Secondary Endpoints [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Change in diabetes medications.
  • Secondary Endpoints [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Change in various mental health assessments
Same as current
Not Provided
Not Provided
 
Weight Loss Study for People With Type 2 Diabetes
Effects on Glycemic Control and Weight of a Modified Commercial Weight Control Program for People With Type 2 Diabetes

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Overweight
  • Obesity
  • Behavioral: 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
  • Other: Standard Care group
    One session of in-person diabetic nutritional counseling with a registered dietitian, with follow-up written educational materials.
  • Experimental: Modified Weight Watchers program
    Intervention: Behavioral: Weight Watchers modified program
  • Active Comparator: Standard Diabetes Counseling group
    Intervention: Other: Standard Care group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
563
September 2014
May 2014   (final data collection date for primary outcome measure)

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 -
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01601574
WW-MUSC-1201
No
Medical University of South Carolina
Medical University of South Carolina
Weight Watchers International
Study Director: Patrick M. O'Neil, PhD MUSC
Medical University of South Carolina
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP