A Weight Loss RCT Comparing Keyto vs Weight Watchers

Not Applicable

Completed

• Conditions: Overweight and Obesity; Ketogenic Diet
• Interventions: Other: Weight Watchers app; Device: Keyto device + app

• Registration Number: NCT04165707
• Lead Sponsor: University of British Columbia

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-18
• Study Start: 2019-12-09
• Primary Completion: 2021-01-02
• Status Verified: 2021-08
• Study Completion: 2021-08-11
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight Watchers comparator arm	Weight Watchers app	Weight Watchers app
Keyto intervention arm	Keyto device + app	Keyto device + app

Primary Outcome Measures

Name	Time	Method
Change in body mass at 12 weeks	12 weeks from baseline	Change in body mass (in kilograms)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of British Columbia; 🇨🇦 Kelowna, British Columbia, Canada