Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Overweight and Obesity
  • Type2 Diabetes
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

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 Weig...

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.

Tracking Information

NCT #
NCT04804774
Collaborators
WW International Inc.
Investigators
Principal Investigator: John W Apolzan, PhD Pennington Biomedical Research Center Principal Investigator: Jessica G LaRose, PhD Virginia Commonwealth University Principal Investigator: Stephen Anton, PhD University of Florida