Comparing the Keyto App and Device with Weight Watchers’ WW App for Weight Loss: Protocol for a Randomized Trial (Preprint)

Abstract

BACKGROUND Overweight and obesity 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 mHealth application paired with a non-invasive 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 mobile app + device intervention to the Weight Watchers (WW) mobile app in individuals with overweight or obesity. The primary outcome is weight loss 12 weeks from baseline. Secondary and exploratory outcomes, including metabolic and cardiovascular risk factors, will be assessed at 12, 24 and 48 weeks following baseline. METHODS A total of 144 participants will be recruited and randomized to either the Keyto program or WW program. Study participants will be guided through the study via video-conference or phone calls and will undergo a fasting blood analysis at weeks 0 and 12 to assess metabolic and cardiovascular risk markers by a third-party diagnostic lab. 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, via the Keyto device three 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-up time points 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 with overweight and obesity 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. CLINICALTRIAL ClinicalTrials.gov NCT04165707