At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Controlled Trial Comparing Weight Loss Effects Between the Keyto Virtual "Ketogenic Diet" Program Compared to a Standard-care Weight Loss App
In Brief
A clinical study evaluating Keyto device + app and Weight Watchers app for Overweight and Obesity and Ketogenic Diet. Completed, enrolled 155 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
The Weight Watchers app helps people to monitor their food intake, track points and provides recipe ideas to support weight loss.