Weight Loss Study for People With Type 2 Diabetes

Phase 3

Completed

• Conditions: Overweight; Obesity; Type 2 Diabetes
• Interventions: Behavioral: Weight Watchers modified program; Other: Standard Care group

• Registration Number: NCT01601574
• Lead Sponsor: Medical University of South Carolina

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-03
• Study First Submitted: 2012-04-27
• Study Start: 2012-05
• Study First Submitted QC: 2012-05-17
• Study First Posted: 2012-05-18
• Primary Completion: 2014-05
• Study Completion: 2014-09
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 563

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Weight Watchers program	Weight Watchers modified program	-
Standard Diabetes Counseling group	Standard Care group	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	Baseline and 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoints	Baseline and 12 months	Change in various mental health assessments

Trial Locations

Locations (15)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

The University of Pennsylvania Center for Weight and Eating Disorders; 🇺🇸 Philadelphia, Pennsylvania, United States

CSRA Partners in Health; 🇺🇸 Augusta, Georgia, United States

Diabetes Research and Training Center, University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Center for Nutrition and Preventive Medicine; 🇺🇸 Charlotte, North Carolina, United States

Obesity Research Center St. Luke's Roosevelt Hospital Center; 🇺🇸 New York, New York, United States

Your Diabetes Endocrine Nutrition Group Inc.; 🇺🇸 Mentor, Ohio, United States

Northwestern University Feinberg School; 🇺🇸 Chicago, Illinois, United States

Scripps Clinical Research; 🇺🇸 La Jolla, California, United States

Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States

Obesity Clinical Trials Program Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Oregon Weight Loss Surgery, LLC; 🇺🇸 Portland, Oregon, United States

Oakwell Clinical Research; 🇺🇸 San Antonio, Texas, United States

Washington Center for Weight Management & Research, Inc The Navy League Building; 🇺🇸 Arlington, Virginia, United States

Baylor Endocrine Center; 🇺🇸 Dallas, Texas, United States