Comparing the Keyto App and Device with Weight Watchers' WW App for Weight Loss: Protocol for a Randomized Trial

Overview

Journal JMIR Res Protoc

Publisher JMIR Publications

Specialty General Medicine

Date 2020 Aug 18

PMID 32804087

Citations 4

Authors

Sean R Locke

Kaja Falkenhain

Dylan A Lowe

Terry Lee

Joel Singer

Ethan J Weiss

Jonathan P Little

Affiliations

Soon will be listed here.

Abstract

Background: Obesity and being overweight are major contributing factors for many diseases. Calorie restricted diets often fail to result in sustained long-term weight loss. Very low-carbohydrate, high-fat ketogenic diets have been suggested to have superior metabolic and weight loss effects. Keyto is a low-cost, highly scalable mobile health (mHealth) app paired with a noninvasive biofeedback tool aimed at facilitating weight loss through a personalized healthy and predominantly plant- and fish-based ketogenic diet.

Objective: This protocol describes a randomized trial comparing the efficacy of the Keyto mHealth app and device intervention to that of Weight Watchers' WW app in individuals who are overweight or obese. The primary outcome is weight loss after 12 weeks. Secondary and exploratory outcomes, including metabolic and cardiovascular risk factors, will be assessed at 12, 24, and 48 weeks.

Methods: A total of 144 participants will be recruited and randomized to either the Keyto program or Weight Watchers program. Study participants will be guided through the study via video conference or phone calls and will undergo a fasting blood analysis performed by a third-party diagnostic lab at weeks 0 and 12 to assess metabolic and cardiovascular risk markers. All participants will be asked to weigh themselves daily on a study-provided Bluetooth-enabled scale. Participants randomized to the Keyto arm will also be asked to measure their breath acetone levels, a measure of ketosis, with the Keyto device 3 times per day.

Results: Recruitment started in December 2019. Rolling recruitment is expected to be completed by July 2020. Data collection and analysis of the primary intervention phase is expected to be completed in October 2020. The 24- and 48-week follow-ups are expected to be completed in January 2021 and July 2021, respectively.

Conclusions: This trial will provide high-quality evidence regarding the efficacy of the Keyto weight loss program in individuals who are overweight and obese in a free-living condition. This study also fills a gap by examining the impact of a ketogenic diet emphasizing plant- and fish-based fats on blood lipid profile and cardiovascular disease risk.

Trial Registration: ClinicalTrials.gov NCT04165707; https://clinicaltrials.gov/ct2/show/NCT04165707.

International Registered Report Identifier (irrid): DERR1-10.2196/19053.

Citing Articles

Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity.

Metzendorf M, Wieland L, Richter B Cochrane Database Syst Rev. 2024; 2:CD013591.

PMID: 38375882 PMC: 10877670. DOI: 10.1002/14651858.CD013591.pub2.

Use of an mHealth Ketogenic Diet App Intervention and User Behaviors Associated With Weight Loss in Adults With Overweight or Obesity: Secondary Analysis of a Randomized Clinical Trial.

Falkenhain K, Locke S, Lowe D, Lee T, Singer J, Weiss E JMIR Mhealth Uhealth. 2022; 10(3):e33940.

PMID: 35285809 PMC: 8961343. DOI: 10.2196/33940.

Low-carbohydrate versus balanced-carbohydrate diets for reducing weight and cardiovascular risk.

Naude C, Brand A, Schoonees A, Nguyen K, Chaplin M, Volmink J Cochrane Database Syst Rev. 2022; 1:CD013334.

PMID: 35088407 PMC: 8795871. DOI: 10.1002/14651858.CD013334.pub2.

Keyto app and device versus WW app on weight loss and metabolic risk in adults with overweight or obesity: A randomized trial.

Falkenhain K, Locke S, Lowe D, Reitsma N, Lee T, Singer J Obesity (Silver Spring). 2021; 29(10):1606-1614.

PMID: 34124856 PMC: 8518592. DOI: 10.1002/oby.23242.

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