NCT04165707

A Weight Loss RCT Comparing Keyto vs Weight Watchers

A Randomized Controlled Trial Comparing Weight Loss Effects Between the Keyto Virtual "Ketogenic Diet" Program Compared to a Standard-care Weight Loss App

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Very low-carbohydrate ketogenic diet may have beneficial metabolic and weight loss effects, however, adhering to this diet may be challenging. Keyto is a self-monitoring and app-enhanced intervention to help individuals learn about and monitor their breath acetone (a measure of ketosis) levels to promote dietary change and weight loss. The purpose of this research is to test the Keyto self-monitoring + app intervention against a "standard of care" weight loss dietary app (Weight Watchers). 144 participants will be recruited through Facebook ads, provide online consent, and will be randomized to one of the two conditions. Weight loss after 12 weeks will be assessed as the primary outcome, with weight loss at 24 and 48 weeks being secondary outcomes. Blood samples will be collected at baseline and 12 weeks with optional blood samples at 48 weeks follow up.

Conditions

• Overweight and Obesity
• Ketogenic Diet

Interventions

Type	Name	Description
DEVICE	Keyto device + app	Keyto is a self-monitoring and app-enhanced intervention to help individuals learn about and monitor their breath acetone (a measure of ketosis) levels to promote a very low carbohydrate diet and weight loss.
OTHER	Weight Watchers app	The Weight Watchers app helps people to monitor their food intake, track points and provides recipe ideas to support weight loss.

Timeline

• Start date: 2019-12-09
• Primary completion: 2021-01-02
• Completion: 2021-08-11
• First posted: 2019-11-18
• Last updated: 2021-08-26

Locations

1 site across 1 country: Canada