Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Overweight
Obesity
Behavioral: Weight Watchers modified program
Other: Standard Care group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects on Glycemic Control and Weight of a Modified Commercial Weight Control Program for People With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 563
Study Start Date: May 2012
Study Completion Date: September 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modified Weight Watchers program 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
Active Comparator: Standard Diabetes Counseling group Other: Standard Care group
One session of in-person diabetic nutritional counseling with a registered dietitian, with follow-up written educational materials.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601574

Locations
United States, Alabama
Diabetes Research and Training Center, University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Scripps Clinical Research
La Jolla, California, United States, 92037
United States, Georgia
CSRA Partners in Health
Augusta, Georgia, United States, 30909-6599
United States, Illinois
Northwestern University Feinberg School
Chicago, Illinois, United States, 60611
United States, New York
Obesity Research Center St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10025
Weill Medical College of Cornell University
New York, New York, United States, 10065
United States, North Carolina
Center for Nutrition and Preventive Medicine
Charlotte, North Carolina, United States, 28277
Obesity Clinical Trials Program Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Your Diabetes Endocrine Nutrition Group Inc.
Mentor, Ohio, United States, 44060
United States, Oregon
Oregon Weight Loss Surgery, LLC
Portland, Oregon, United States, 97210
United States, Pennsylvania
The University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Baylor Endocrine Center
Dallas, Texas, United States, 75246-1906
Oakwell Clinical Research
San Antonio, Texas, United States, 78218
United States, Virginia
Washington Center for Weight Management & Research, Inc The Navy League Building
Arlington, Virginia, United States, 22201
Sponsors and Collaborators
Medical University of South Carolina
Weight Watchers International
Investigators
Study Director: Patrick M. O'Neil, PhD MUSC
  More Information

Additional Information:
No publications provided

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01601574     History of Changes
Other Study ID Numbers: WW-MUSC-1201
Study First Received: April 27, 2012
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Type 2 diabetes
HbA1c
Overweight
Obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Overweight
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014