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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Type 2 Diabetes
• Intervention / Treatment: Behavioral: Weight Watchers modified program; Other: Standard Care group

• Study Type: Interventional
• Enrollment (Actual): 563
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Weight Watchers International
• Investigators: Study Director: Patrick M. O'Neil, PhD, Medical University of South Carolina

Publications and helpful links

General Publications

• 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.

Helpful Links

• The University of Pennsylvania Center for Weight and Eating Disorders
• Your Diabetes Endocrine Nutrition Group, Inc
• Medical University of South Carolina
• Obesity Clinical Trials Program Duke University Medical Center
• Oregon Weight Loss Surgery, LLC
• Scripps Nutrition and Metabolic & Research
• University of Alabama at Birmingham Department of Nutrition
• The Washington Center for Weight Management & Research
• Baylor Research
• Oakwell Clinical Research

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: April 27, 2012
• First Submitted That Met QC Criteria: May 17, 2012
• First Posted (ESTIMATE): May 18, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 14, 2014
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Obesity; HbA1c; Type 2 diabetes; Overweight
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
• Other Study ID Numbers: WW-MUSC-1201