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Randomized Controlled Trial
. 2021 Oct;29(10):1606-1614.
doi: 10.1002/oby.23242. Epub 2021 Sep 14.

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

Affiliations
Randomized Controlled Trial

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

Kaja Falkenhain et al. Obesity (Silver Spring). 2021 Oct.

Abstract

Objective: The aim of this study was to determine whether a Mediterranean-style, ketogenic diet mobile health application (app) with breath acetone biofeedback is superior to a calorie-restricted, low-fat diet app in promoting weight loss.

Methods: Participants (n = 155) with overweight/obesity (mean [SD]: age 41 [11] years, BMI = 34 [5] kg/m2 , 71% female) were randomized to one of the interventions delivered entirely via app. Participants received a wireless scale and were instructed to take daily weight measurements. A third-party laboratory collected blood samples at baseline and 12 weeks.

Results: Weight loss at 12 weeks was greater in the ketogenic (-5.6 kg; 95% CI: -6.7 kg to -4.5 kg) compared with the low-fat group (-2.5 kg; 95% CI: -3.6 kg to -1.4 kg) (between-group difference: -3.1 kg; 95% CI: -4.6 kg to -1.5 kg; p < 0.001). Weight loss at 24 weeks indicated durability of the effect (between-group difference: -5.5 kg; 95% CI: -8.3 kg to -2.8 kg; p < 0.001). Secondary/exploratory outcomes of hemoglobin A1c and liver enzymes were improved to a greater extent in the ketogenic diet group (p < 0.01).

Conclusions: Among adults with overweight/obesity, a ketogenic diet app with breath acetone biofeedback was superior to a calorie-restricted diet app at promoting weight loss in a real-world setting.

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Conflict of interest statement

JPL is chief scientific officer for the Institute for Personalized Therapeutic Nutrition, a not‐for‐profit organization promoting a food‐first approach to treating and preventing chronic disease. JPL holds shares in Metabolic Insights Inc., a for‐profit company developing a saliva insulin monitor. EJW is an equity holder at Keyto and Virta Health. DAL is employed as a consultant for Keyto. All other authors have no conflicts to declare.

Figures

FIGURE 1
FIGURE 1
CONSORT flow diagram describing the process of determining participant eligibility, enrollment, random assignment, and data analysis. CONSORT, Consolidated Standards of Reporting Trials [Colour figure can be viewed at wileyonlinelibrary.com]
FIGURE 2
FIGURE 2
Weight change at 12 weeks in ketogenic diet app with biofeedback and calorie‐restricted, low‐fat diet app groups including individual participant data points. (A) Individual change in body weight (calculated as daily percent change from baseline based on measurements recorded from an at‐home Bluetooth scale) are shown for each participant over time throughout the duration of the study. Daily mean values over time for each group are represented in solid lines (orange, ketogenic diet app with biofeedback; blue, calorie‐restricted, low‐fat diet app). (B) Waterfall plots showing percent weight change from baseline for each participant in the ketogenic diet app with biofeedback group (top) and calorie‐restricted, low‐fat diet app group (bottom) [Colour figure can be viewed at wileyonlinelibrary.com]

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