NCT04804774

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

Single-Arm Trial of a Virtual Weight Control Program Tailored for Adults With Type 2 Diabetes on Glycemic Control (VITAL)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Type2 Diabetes
• Overweight and Obesity

Interventions

Type	Name	Description
BEHAVIORAL	WW program modified for people with Type 2 diabetes	This 6-month intervention includes the use of WW's mobile app, weekly virtual workshops, and private online community. The program involves: self-monitoring of weight, dietary intake, and physical activity; dietary changes; increasing physical activity; shift in mindset; and behavioral strategies to manage goals. Participants will set goals and weigh-in with a coach via virtual workshop weekly and be encouraged to use the app and private online community daily. The virtual workshop features a behavior change technique and enables the participant to practice it to support their goals. Participants are given a personalized food plan based on expert healthy eating guidelines, an activity plan to promote regular physical activity and techniques to help shift mindset for lasting change. The coach will help with goal setting, overcoming setbacks, and follow-up on progress toward goals weekly. Participants will be encouraged to participate in a private Facebook group for motivational support.

Timeline

• Start date: 2021-03-23
• Primary completion: 2021-12-22
• Completion: 2021-12-22
• First posted: 2021-03-18
• Last updated: 2022-06-21

Locations

3 sites across 1 country: United States