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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
563
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
One session of in-person diabetic nutritional counseling with a registered dietitian, with follow-up written educational materials.
Diabetes Research and Training Center, University of Alabama at Birmingham
Birmingham, Alabama, United States
Scripps Clinical Research
La Jolla, California, United States
Change in HbA1c
Time frame: Baseline and 12 months
Secondary Endpoints
Change in weight
Time frame: Baseline and 12 months
Secondary Endpoints
Change in BMI
Time frame: Baseline and 12 months
Secondary Endpoints
Change in waist circumference
Time frame: Baseline and 12 months
Secondary Endpoints
Change in fasting blood glucose
Time frame: Baseline and 12 months
Secondary Endpoints
Change in HOMA
Time frame: Baseline and 12 months
Secondary Endpoints
Change in cardiovascular risk markers (lipid measures, blood pressure, C-Reactive Protein)
Time frame: Baseline and 12 months
Secondary Endpoints
Change in diabetes medications.
Time frame: Baseline and 12 months
Secondary Endpoints
Change in various mental health assessments
Time frame: Baseline and 12 months
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CSRA Partners in Health
Augusta, Georgia, United States
Northwestern University Feinberg School
Chicago, Illinois, United States
Obesity Research Center St. Luke's Roosevelt Hospital Center
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Center for Nutrition and Preventive Medicine
Charlotte, North Carolina, United States
Obesity Clinical Trials Program Duke University Medical Center
Durham, North Carolina, United States
Your Diabetes Endocrine Nutrition Group Inc.
Mentor, Ohio, United States
Oregon Weight Loss Surgery, LLC
Portland, Oregon, United States
...and 5 more locations