Virtual Weight Control Program Tailored for Adults With Type 2 Diabetes

Status Completed

Clinical Trial Summary

The purpose of the study is to evaluate the effect of the WW program on people with Type 2 diabetes and the effect on glycemic control. This study will be a 6 month prospective, single arm clinical trial coordinated by Pennington Biomedical Research Center. Up to 150 participants will be recruited across 3 sites. Participants will have Type 2 diabetes and overweight/obesity.

Clinical Trial Description

While weight loss (2-5% of total bodyweight) with clinical interventions has been shown to improve glycemic control in patients with Type II Diabetes clinic-based interventions are costly and have poor accessibility for the majority of patients. Commercial weight loss programs like WW (formerly Weight Watchers) are more affordable and accessible than clinic-based modalities, and have been shown to produce effective weight loss in adults with additional improvements in glycemic control. A randomized trial of a modified WW program for patients with Type II Diabetes showed significant reductions in weight and improved glycemic control (HbA1c) compared to standard of care diabetes nutrition counseling and education. Here, we extend prior work by leveraging the efficacy of the WW program for Type II Diabetes, virtually, to increase its reach and its impact on glycemic control. This study aims to test a novel, web-based weight loss intervention from one of the largest and most evidence-based proprietary weight loss programs in the world. Intervention will consist of the WW program modified for people with Type 2 diabetes including weekly Virtual Workshops and use of the WW App. Primary outcomes are any change in HbA1c% over the 6-month intervention. Secondary endpoints are any change in HbA1c% at 3 months, as well as changes at 3 and 6 months in weight, Diabetes Distress Scale, Impact of Weight on Quality of Life, Pittsburgh Sleep Quality Index, hypoglycemic events, WHO-5 Well-being Index, and diabetes medication changes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04804774
Study type	Interventional
Source	Pennington Biomedical Research Center
Contact
Status	Completed
Phase	N/A
Start date	March 23, 2021
Completion date	December 22, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Virtual Weight Control Program Tailored for Adults With Type 2 Diabetes (VITAL) — VITAL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms