NCT02000024|Completed
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Sponsor study identifier
interventional
225
1 country
1
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
Actual (reported)Study Completion
March 2016
Actual (reported)This study is a randomized pilot study to assess the applicability of the Weight Watchers model for lifestyle modification to the primary prevention of type 2 diabetes. The approach developed by Weight Watchers to achieve weight loss is based on similar nutritional principals and techniques used in the Diabetes Prevention Program (DPP) lifestyle intervention; monitoring food intake, exercising calorie control, setting modest weight loss goals and using physical activity.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
November 26, 2013
Actual (reported)December 3, 2013
Actual (reported)October 2015
Actual (reported)March 2016
Actual (reported)Changes in weight
6, 12, 19 and 24 months from baseline
Changes in A1c
6, 12, 19 and 24 months from baseline
Changes in systolic blood pressure
6, 12, 19 and 24 months from baseline
Changes in total cholesterol
6, 12, 19 and 24 months from baseline
Changes in HDL-cholesterol
6, 12, 19 and 24 months from baseline
The existing Weight Watchers lifestyle modification program including the online support tools.
Brief advice regarding risk factors and strategies to reduce them by lifestyle modification guided by National Diabetes Education Program (NDEP) materials.
The standard Weight Watchers program will serve as the base curriculum. Persons with increased risk for developing type 2 diabetes will be exposed to an initial "orientation session" designed to frame the rationale for participation in the program and to encourage attendance to a core series of sessions. This orientation session will reinforce the pre-diabetes status of participants and present the rationale for lifestyle modification as a means to reduce diabetes risk. In addition, this session will highlight the recommended sessions and topics that are needed to help reduce risk.
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Marrero DG, Palmer KN, Phillips EO, Miller-Kovach K, Foster GD, Saha CK. Comparison of Commercial and Self-Initiated Weight Loss Programs in People With Prediabetes: A Randomized Control Trial. Am J Public Health. 2016 May;106(5):949-56. doi: 10.2105/AJPH.2015.303035. Epub 2016 Feb 18.
David G Marrero, Ph.D.
Indiana University
225 participants (actual enrollment reported by the registry).
First Submitted
November 26, 2013
First Posted
December 3, 2013
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Better Me Within Trial to Improve Lifestyle Behaviors in African Americans
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 2015
Actual (reported)Study Completion
March 2016
Actual (reported)Last Updated
April 8, 2016
Record last verified: 2016-04
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Source: ClinicalTrials.gov.
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