A Weight Loss RCT Comparing Keyto vs Weight Watchers

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04165707
• Other study ID #: H19-01341
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: August 11, 2021

Study information

• Verified date: August 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: August 11, 2021
• Est. primary completion date: January 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Ketogenic Diet
• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
Canada	University of British Columbia	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fasting albumin	Blood test will determine changes in serum albumin	12 and 48 weeks from baseline
Other	Fasting globulin	Blood test will determine changes in serum globulin	12 and 48 weeks from baseline
Other	Fasting total bilirubin	Blood test will determine changes in serum bilirubin	12 and 48 weeks from baseline
Other	Fasting alkaline phosphatase	Blood test will determine changes in serum alkaline phosphatase	12 and 48 weeks from baseline
Other	Fasting aspartate aminotransferase	Blood test will determine changes in serum aspartate aminotransferase	12 and 48 weeks from baseline
Other	Fasting alanine aminotransferase	Blood test will determine changes in serum alanine aminotransferase	12 and 48 weeks from baseline
Primary	Change in body mass at 12 weeks	Change in body mass (in kilograms)	12 weeks from baseline
Secondary	Change in body mass at 24 and 48 weeks	Change in body mass (in kilograms)	24 and 48 weeks from baseline
Secondary	Carbohydrate intake	Total consumption of carbohydrates in 24 hour period (in grams)	12, 24, and 48 weeks from baseline
Secondary	Total fat intake	Total consumption of fat in 24 hour period (in grams)	12, 24, and 48 weeks from baseline
Secondary	Saturated fat intake	Total consumption of saturated fat in 24 hour period (in grams)	12, 24, and 48 weeks from baseline
Secondary	Polyunsaturated fat intake	Total consumption of polyunsaturated fat in 24 hour period (in grams)	12, 24, and 48 weeks from baseline
Secondary	Monounsaturated fat intake	Total consumption of monounsaturated fat in 24 hour period (in grams)	12, 24, and 48 weeks from baseline
Secondary	Total energy intake	Total energy intake in 24 hour period (in kilocalories)	12, 24, and 48 weeks from baseline
Secondary	HbA1C	Blood test will be used to determine changes in HbA1C	12 and 48 weeks from baseline
Secondary	Fasting glucose	Blood test will be used to determine changes in fasting serum glucose	12 and 48 weeks from baseline
Secondary	Fasting insulin	Blood test will be used to determine changes in fasting serum insulin	12 and 48 weeks from baseline
Secondary	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
Secondary	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
Secondary	Fasting total cholesterol	Blood test will be used to determine changes in serum total cholesterol	12 and 48 weeks from baseline
Secondary	Fasting high-density lipoprotein (HDL) cholesterol	Blood test will be used to determine changes in serum HDL cholesterol	12 and 48 weeks from baseline
Secondary	Fasting lipoprotein fractions	Blood test will determine changes in serum lipoprotein fractions measured by ion mobility	12 and 48 weeks from baseline
Secondary	Fasting lipoprotein (a)	Blood test will determine changes in serum lipoprotein (a)	12 and 48 weeks from baseline
Secondary	Fasting triglycerides	Blood test will determine changes in serum trigylcerides	12 and 48 weeks from baseline
Secondary	Fasting non-HDL cholesterol	Blood test will determine changes in serum non-HDL cholesterol	12 and 48 weeks from baseline