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A Weight Loss RCT Comparing Keyto vs Weight Watchers

Primary Purpose

Overweight and Obesity, Ketogenic Diet

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Keyto device + app
Weight Watchers app
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring diet, weight loss, ketogenic diet, low carbohydrate

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Keyto intervention arm

Weight Watchers comparator arm

Arm Description

Keyto device + app

Weight Watchers app

Outcomes

Primary Outcome Measures

Change in body mass at 12 weeks
Change in body mass (in kilograms)

Secondary Outcome Measures

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

Full Information

First Posted
November 6, 2019
Last Updated
August 24, 2021
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04165707
Brief Title
A Weight Loss RCT Comparing Keyto vs Weight Watchers
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
January 2, 2021 (Actual)
Study Completion Date
August 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Ketogenic Diet
Keywords
diet, weight loss, ketogenic diet, low carbohydrate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Keyto intervention arm
Arm Type
Experimental
Arm Description
Keyto device + app
Arm Title
Weight Watchers comparator arm
Arm Type
Active Comparator
Arm Description
Weight Watchers app
Intervention Type
Device
Intervention Name(s)
Keyto device + app
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Weight Watchers app
Intervention Description
The Weight Watchers app helps people to monitor their food intake, track points and provides recipe ideas to support weight loss.
Primary Outcome Measure Information:
Title
Change in body mass at 12 weeks
Description
Change in body mass (in kilograms)
Time Frame
12 weeks from baseline
Secondary Outcome Measure Information:
Title
Change in body mass at 24 and 48 weeks
Description
Change in body mass (in kilograms)
Time Frame
24 and 48 weeks from baseline
Title
Carbohydrate intake
Description
Total consumption of carbohydrates in 24 hour period (in grams)
Time Frame
12, 24, and 48 weeks from baseline
Title
Total fat intake
Description
Total consumption of fat in 24 hour period (in grams)
Time Frame
12, 24, and 48 weeks from baseline
Title
Saturated fat intake
Description
Total consumption of saturated fat in 24 hour period (in grams)
Time Frame
12, 24, and 48 weeks from baseline
Title
Polyunsaturated fat intake
Description
Total consumption of polyunsaturated fat in 24 hour period (in grams)
Time Frame
12, 24, and 48 weeks from baseline
Title
Monounsaturated fat intake
Description
Total consumption of monounsaturated fat in 24 hour period (in grams)
Time Frame
12, 24, and 48 weeks from baseline
Title
Total energy intake
Description
Total energy intake in 24 hour period (in kilocalories)
Time Frame
12, 24, and 48 weeks from baseline
Title
HbA1C
Description
Blood test will be used to determine changes in HbA1C
Time Frame
12 and 48 weeks from baseline
Title
Fasting glucose
Description
Blood test will be used to determine changes in fasting serum glucose
Time Frame
12 and 48 weeks from baseline
Title
Fasting insulin
Description
Blood test will be used to determine changes in fasting serum insulin
Time Frame
12 and 48 weeks from baseline
Title
Fasting high-sensitivity C-reactive protein
Description
Blood test will be used to determine changes in fasting serum high-sensitivity C-reactive protein
Time Frame
12 and 48 weeks from baseline
Title
Fasting homeostasis model assessment of insulin resistance (HOMA-IR)
Description
Blood test will be used to determine changes in HOMA-IR
Time Frame
12 and 48 weeks from baseline
Title
Fasting total cholesterol
Description
Blood test will be used to determine changes in serum total cholesterol
Time Frame
12 and 48 weeks from baseline
Title
Fasting high-density lipoprotein (HDL) cholesterol
Description
Blood test will be used to determine changes in serum HDL cholesterol
Time Frame
12 and 48 weeks from baseline
Title
Fasting lipoprotein fractions
Description
Blood test will determine changes in serum lipoprotein fractions measured by ion mobility
Time Frame
12 and 48 weeks from baseline
Title
Fasting lipoprotein (a)
Description
Blood test will determine changes in serum lipoprotein (a)
Time Frame
12 and 48 weeks from baseline
Title
Fasting triglycerides
Description
Blood test will determine changes in serum trigylcerides
Time Frame
12 and 48 weeks from baseline
Title
Fasting non-HDL cholesterol
Description
Blood test will determine changes in serum non-HDL cholesterol
Time Frame
12 and 48 weeks from baseline
Other Pre-specified Outcome Measures:
Title
Fasting albumin
Description
Blood test will determine changes in serum albumin
Time Frame
12 and 48 weeks from baseline
Title
Fasting globulin
Description
Blood test will determine changes in serum globulin
Time Frame
12 and 48 weeks from baseline
Title
Fasting total bilirubin
Description
Blood test will determine changes in serum bilirubin
Time Frame
12 and 48 weeks from baseline
Title
Fasting alkaline phosphatase
Description
Blood test will determine changes in serum alkaline phosphatase
Time Frame
12 and 48 weeks from baseline
Title
Fasting aspartate aminotransferase
Description
Blood test will determine changes in serum aspartate aminotransferase
Time Frame
12 and 48 weeks from baseline
Title
Fasting alanine aminotransferase
Description
Blood test will determine changes in serum alanine aminotransferase
Time Frame
12 and 48 weeks from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Little, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V 1V7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35285809
Citation
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.
Results Reference
derived
PubMed Identifier
32804087
Citation
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.
Results Reference
derived

Learn more about this trial

A Weight Loss RCT Comparing Keyto vs Weight Watchers

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