T2D: Weight Loss Study for People With Type 2 Diabetes

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT01601574
• Collaborator: Weight Watchers International (Industry)
• Enrollment: 563
• Locations: 15
• Arms: 2
• Duration (Months): 28
• Patients Per Site: 37.5
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes; Overweight; Obesity	Behavioral: Weight Watchers modified program; Other: Standard Care group	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 563 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in HbA1c [Baseline and 12 months]

Secondary Outcome Measures

1. Secondary Endpoints [Baseline and 12 months]

   Change in weight

2. Secondary Endpoints [Baseline and 12 months]

   Change in BMI

3. Secondary Endpoints [Baseline and 12 months]

   Change in waist circumference

4. Secondary Endpoints [Baseline and 12 months]

   Change in fasting blood glucose

5. Secondary Endpoints [Baseline and 12 months]

   Change in HOMA

6. Secondary Endpoints [Baseline and 12 months]

   Change in cardiovascular risk markers (lipid measures, blood pressure, C-Reactive Protein)

7. Secondary Endpoints [Baseline and 12 months]

   Change in diabetes medications.

8. Secondary Endpoints [Baseline and 12 months]

   Change in various mental health assessments

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. Evidence of more than 1 severe hypoglycemic event in the past 12 months, unless the participant's treating physician provides written clearance for participation.

1. 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

Locations

	Site	City	State	Country	Postal Code
1	Diabetes Research and Training Center, University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Scripps Clinical Research	La Jolla	California	United States	92037
3	CSRA Partners in Health	Augusta	Georgia	United States	30909-6599
4	Northwestern University Feinberg School	Chicago	Illinois	United States	60611
5	Obesity Research Center St. Luke's Roosevelt Hospital Center	New York	New York	United States	10025
6	Weill Medical College of Cornell University	New York	New York	United States	10065
7	Center for Nutrition and Preventive Medicine	Charlotte	North Carolina	United States	28277
8	Obesity Clinical Trials Program Duke University Medical Center	Durham	North Carolina	United States	27710
9	Your Diabetes Endocrine Nutrition Group Inc.	Mentor	Ohio	United States	44060
10	Oregon Weight Loss Surgery, LLC	Portland	Oregon	United States	97210
11	The University of Pennsylvania Center for Weight and Eating Disorders	Philadelphia	Pennsylvania	United States	19104
12	Medical University of South Carolina	Charleston	South Carolina	United States	29425
13	Baylor Endocrine Center	Dallas	Texas	United States	75246-1906
14	Oakwell Clinical Research	San Antonio	Texas	United States	78218
15	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, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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

Publications

None provided.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT01601574
• Other Study ID Numbers: WW-MUSC-1201
• First Posted: May 18, 2012
• Last Update Posted: Oct 15, 2014
• Last Verified: Mar 1, 2012

• Keywords provided by Medical University of South Carolina: Type 2 diabetes; HbA1c; Overweight; Obesity
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight

Study Results

No Results Posted as of Oct 15, 2014