A Weight Loss RCT Comparing Keyto vs Weight Watchers

NCT04165707 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2021-08-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Jonathan Little, PhD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-09
Primary Completion
2021-01-02
Completion
2021-08-11

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04165707 on ClinicalTrials.gov