A Weight Loss RCT Comparing Keyto vs Weight Watchers

A Randomized Controlled Trial Comparing Weight Loss Effects Between the Keyto Virtual "Ketogenic Diet" Program Compared to a Standard-care Weight Loss App

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 Overview

• Status: Completed
• Conditions: Overweight and Obesity; Ketogenic Diet
• Intervention / Treatment: Device: Keyto device + app; Other: Weight Watchers app

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1V 1V7
      • University of British Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-64
• Living in the State of California
• Body mass index (BMI) 27-43
• Must speak, read, and comprehend English
• Access to reliable internet and wi-fi
• Must have a valid email address and phone number
• Must have an Apple iPhone (iPhone 7 or later, iOS 11 or later) with cellular data plan
• Must have a kitchen and be willing to cook
• Willingness to reduce carbohydrate intake to less than 30g/day
• Willingness to restrict intake of added sugar, bread, grain, rice, pasta, sweets, most fruits, pastries, and other carbohydrates
• Willingness to comply with a strict diet for 12 months
• Willingness to eat a diet that is primarily plant and fish-based
• Interest in losing weight

Exclusion Criteria:

• HIV or immunocompromised
• Current or past cancer diagnosis
• Pregnant, breastfeeding, or planned pregnancy in next 12 months
• Beginning or ending hormonal contraception in next 12 months
• Current diagnosis of diabetes
• History of heart attack or stent
• Currently taking glucose-lowering drugs, statins, or oral steroids
• History of gastric bypass surgery or any other weight-loss surgery
• History of anorexia or bulimia
• History of mental illness
• Current smoker or smoked cigarettes within past 12 months
• Currently eating fewer than 50 g carbohydrates per day
• Have tried a low-carb, high fat (ketogenic diet) within the past 3 months
• Recent weight loss or gain of more than 5% body weight in past 6 months
• Previous experience with the Weight Watchers diet app
• Experience with a low-carbohydrate of ketogenic diet within past 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Keyto intervention arm; Keyto device + app	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.
Active Comparator: Weight Watchers comparator arm; Weight Watchers app	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body mass at 12 weeks	Change in body mass (in kilograms)	12 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body mass at 24 and 48 weeks	Change in body mass (in kilograms)	24 and 48 weeks from baseline
Carbohydrate intake	Total consumption of carbohydrates in 24 hour period (in grams)	12, 24, and 48 weeks from baseline
Total fat intake	Total consumption of fat in 24 hour period (in grams)	12, 24, and 48 weeks from baseline
Saturated fat intake	Total consumption of saturated fat in 24 hour period (in grams)	12, 24, and 48 weeks from baseline
Polyunsaturated fat intake	Total consumption of polyunsaturated fat in 24 hour period (in grams)	12, 24, and 48 weeks from baseline
Monounsaturated fat intake	Total consumption of monounsaturated fat in 24 hour period (in grams)	12, 24, and 48 weeks from baseline
Total energy intake	Total energy intake in 24 hour period (in kilocalories)	12, 24, and 48 weeks from baseline
HbA1C	Blood test will be used to determine changes in HbA1C	12 and 48 weeks from baseline
Fasting glucose	Blood test will be used to determine changes in fasting serum glucose	12 and 48 weeks from baseline
Fasting insulin	Blood test will be used to determine changes in fasting serum insulin	12 and 48 weeks from baseline
Fasting high-sensitivity C-reactive protein	Blood test will be used to determine changes in fasting serum high-sensitivity C-reactive protein	12 and 48 weeks from baseline
Fasting homeostasis model assessment of insulin resistance (HOMA-IR)	Blood test will be used to determine changes in HOMA-IR	12 and 48 weeks from baseline
Fasting total cholesterol	Blood test will be used to determine changes in serum total cholesterol	12 and 48 weeks from baseline
Fasting high-density lipoprotein (HDL) cholesterol	Blood test will be used to determine changes in serum HDL cholesterol	12 and 48 weeks from baseline
Fasting lipoprotein fractions	Blood test will determine changes in serum lipoprotein fractions measured by ion mobility	12 and 48 weeks from baseline
Fasting lipoprotein (a)	Blood test will determine changes in serum lipoprotein (a)	12 and 48 weeks from baseline
Fasting triglycerides	Blood test will determine changes in serum trigylcerides	12 and 48 weeks from baseline
Fasting non-HDL cholesterol	Blood test will determine changes in serum non-HDL cholesterol	12 and 48 weeks from baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting albumin	Blood test will determine changes in serum albumin	12 and 48 weeks from baseline
Fasting globulin	Blood test will determine changes in serum globulin	12 and 48 weeks from baseline
Fasting total bilirubin	Blood test will determine changes in serum bilirubin	12 and 48 weeks from baseline
Fasting alkaline phosphatase	Blood test will determine changes in serum alkaline phosphatase	12 and 48 weeks from baseline
Fasting aspartate aminotransferase	Blood test will determine changes in serum aspartate aminotransferase	12 and 48 weeks from baseline
Fasting alanine aminotransferase	Blood test will determine changes in serum alanine aminotransferase	12 and 48 weeks from baseline

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Jonathan Little, PhD, University of British Columbia

Publications and helpful links

General Publications

• Falkenhain K, Locke SR, Lowe DA, Lee T, Singer J, Weiss EJ, Little JP. 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. JMIR Mhealth Uhealth. 2022 Mar 14;10(3):e33940. doi: 10.2196/33940.
• Locke SR, Falkenhain K, Lowe DA, Lee T, Singer J, Weiss EJ, Little JP. Comparing the Keyto App and Device with Weight Watchers' WW App for Weight Loss: Protocol for a Randomized Trial. JMIR Res Protoc. 2020 Aug 17;9(8):e19053. doi: 10.2196/19053.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): January 2, 2021
• Study Completion (Actual): August 11, 2021

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: weight loss; ketogenic diet; diet; low carbohydrate
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: H19-01341

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No