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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 : Not yet recruiting
First Posted : November 18, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan Little, 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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Ketogenic Diet Device: Keyto device + app Other: Weight Watchers app Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in body mass at 12 weeks [ Time Frame: 12 weeks from baseline ]
    Change in body mass (in kilograms)


Secondary Outcome Measures :
  1. Change in body mass at 24 and 48 weeks [ Time Frame: 24 and 48 weeks from baseline ]
    Change in body mass (in kilograms)

  2. Carbohydrate intake [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Total consumption of carbohydrates in 24 hour period (in grams)

  3. Total fat intake [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Total consumption of fat in 24 hour period (in grams)

  4. Saturated fat intake [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Total consumption of saturated fat in 24 hour period (in grams)

  5. Polyunsaturated fat intake [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Total consumption of polyunsaturated fat in 24 hour period (in grams)

  6. Monounsaturated fat intake [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Total consumption of monounsaturated fat in 24 hour period (in grams)

  7. Total energy intake [ Time Frame: 12, 24, and 48 weeks from baseline ]
    Total energy intake in 24 hour period (in kilocalories)

  8. HbA1C [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will be used to determine changes in HbA1C

  9. Fasting glucose [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will be used to determine changes in fasting serum glucose

  10. Fasting insulin [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will be used to determine changes in fasting serum insulin

  11. 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

  12. 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

  13. Fasting total cholesterol [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will be used to determine changes in serum total cholesterol

  14. 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

  15. Fasting lipoprotein fractions [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum lipoprotein fractions measured by ion mobility

  16. Fasting lipoprotein (a) [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum lipoprotein (a)

  17. Fasting triglycerides [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum trigylcerides

  18. Fasting non-HDL cholesterol [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum non-HDL cholesterol


Other Outcome Measures:
  1. Fasting albumin [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum albumin

  2. Fasting globulin [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum globulin

  3. Fasting total bilirubin [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum bilirubin

  4. Fasting alkaline phosphatase [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum alkaline phosphatase

  5. Fasting aspartate aminotransferase [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum aspartate aminotransferase

  6. Fasting alanine aminotransferase [ Time Frame: 12 and 48 weeks from baseline ]
    Blood test will determine changes in serum alanine aminotransferase



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165707


Contacts
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Contact: Jonathan Little, PhD 250-807-9876 jonathan.little@ubc.ca
Contact: Sean Locke, PhD 250-807-9876 sean.locke@ubc.ca

Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Jonathan Little, PhD University of British Columbia

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Responsible Party: Jonathan Little, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04165707     History of Changes
Other Study ID Numbers: H19-01341
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Little, University of British Columbia:
diet
weight loss
ketogenic diet
low carbohydrate
Additional relevant MeSH terms:
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Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes