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A Weight Loss RCT Comparing Keyto vs Weight Watchers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04165707
Recruitment Status : Recruiting
First Posted : November 18, 2019
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan Little, University of British Columbia

Tracking Information
First Submitted Date  ICMJE November 6, 2019
First Posted Date  ICMJE November 18, 2019
Last Update Posted Date December 12, 2019
Actual Study Start Date  ICMJE December 9, 2019
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2019)
Change in body mass at 12 weeks [ Time Frame: 12 weeks from baseline ]
Change in body mass (in kilograms)
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
Weight loss at 12 weeks [ Time Frame: 12 weeks from baseline ]
Change in weight (in kilograms)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2019)
  • Change in body mass at 24 and 48 weeks [ Time Frame: 24 and 48 weeks from baseline ]
    Change in body mass (in kilograms)
  • Carbohydrate intake [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Total consumption of carbohydrates in 24 hour period (in grams)
  • Total fat intake [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Total consumption of fat in 24 hour period (in grams)
  • Saturated fat intake [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Total consumption of saturated fat in 24 hour period (in grams)
  • Polyunsaturated fat intake [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Total consumption of polyunsaturated fat in 24 hour period (in grams)
  • Monounsaturated fat intake [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Total consumption of monounsaturated fat in 24 hour period (in grams)
  • Total energy intake [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Total energy intake in 24 hour period (in kilocalories)
  • HbA1C [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will be used to determine changes in HbA1C
  • Fasting glucose [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will be used to determine changes in fasting serum glucose
  • Fasting insulin [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will be used to determine changes in fasting serum insulin
  • Fasting high-sensitivity C-reactive protein [ Time Frame: 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) [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will be used to determine changes in HOMA-IR
  • Fasting total cholesterol [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will be used to determine changes in serum total cholesterol
  • Fasting high-density lipoprotein (HDL) cholesterol [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will be used to determine changes in serum HDL cholesterol
  • Fasting lipoprotein fractions [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum lipoprotein fractions measured by ion mobility
  • Fasting lipoprotein (a) [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum lipoprotein (a)
  • Fasting triglycerides [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum trigylcerides
  • Fasting non-HDL cholesterol [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum non-HDL cholesterol
Original Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
  • Weight loss at 24 and 48 weeks [ Time Frame: 24 and 48 weeks from baseline ]
    Change in weight (in kilograms)
  • Carbohydrate intake [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Total consumption of carbohydrates in 24 hour period (in grams)
  • Waist circumference [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Change in waist circumference (in inches)
  • Blood pressure [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Change in blood pressure (mmHg)
  • HbA1C [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Blood test will be used to determine changes in HbA1C
  • Fasting glucose [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Blood test will be used to determine changes in fasting glucose
  • Fasting insulin [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Blood test will be used to determine changes in fasting insulin
  • Fasting C-peptide [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Blood test will be used to determine changes in fasting C-peptide
  • Insulin sensitivity index [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Blood test will be used to determine changes in insulin sensitivity index
Current Other Pre-specified Outcome Measures
 (submitted: December 3, 2019)
  • Fasting albumin [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum albumin
  • Fasting globulin [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum globulin
  • Fasting total bilirubin [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum bilirubin
  • Fasting alkaline phosphatase [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum alkaline phosphatase
  • Fasting aspartate aminotransferase [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum aspartate aminotransferase
  • Fasting alanine aminotransferase [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum alanine aminotransferase
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Weight Loss RCT Comparing Keyto vs Weight Watchers
Official Title  ICMJE A Randomized Controlled Trial Comparing Weight Loss Effects Between the Keyto Virtual "Ketogenic Diet" Program Compared to a Standard-care Weight Loss App
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight and Obesity
  • Ketogenic Diet
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Keyto intervention arm
    Keyto device + app
    Intervention: Device: Keyto device + app
  • Active Comparator: Weight Watchers comparator arm
    Weight Watchers app
    Intervention: Other: Weight Watchers app
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2019)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jonathan Little, PhD 250-807-9876 jonathan.little@ubc.ca
Contact: Sean Locke, PhD 250-807-9876 sean.locke@ubc.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04165707
Other Study ID Numbers  ICMJE H19-01341
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonathan Little, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan Little, PhD University of British Columbia
PRS Account University of British Columbia
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP