Clinical trial NCT04165707: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Ketogenic Diet
Keywords: diet
weight loss
ketogenic diet
low carbohydrate
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in body mass at 12 weeks
timeFrame: 12 weeks from baseline
Secondary outcomes:
measure: Change in body mass at 24 and 48 weeks
timeFrame: 24 and 48 weeks from baseline
measure: Carbohydrate intake
timeFrame: 12, 24, and 48 weeks from baseline
measure: Total fat intake
timeFrame: 12, 24, and 48 weeks from baseline
measure: Saturated fat intake
timeFrame: 12, 24, and 48 weeks from baseline
measure: Polyunsaturated fat intake
timeFrame: 12, 24, and 48 weeks from baseline
measure: Monounsaturated fat intake
timeFrame: 12, 24, and 48 weeks from baseline
measure: Total energy intake
timeFrame: 12, 24, and 48 weeks from baseline
measure: HbA1C
timeFrame: 12 and 48 weeks from baseline
measure: Fasting glucose
timeFrame: 12 and 48 weeks from baseline
measure: Fasting insulin
timeFrame: 12 and 48 weeks from baseline
measure: Fasting high-sensitivity C-reactive protein
timeFrame: 12 and 48 weeks from baseline
measure: Fasting homeostasis model assessment of insulin resistance (HOMA-IR)
timeFrame: 12 and 48 weeks from baseline
measure: Fasting total cholesterol
timeFrame: 12 and 48 weeks from baseline
measure: Fasting high-density lipoprotein (HDL) cholesterol
timeFrame: 12 and 48 weeks from baseline
measure: Fasting lipoprotein fractions
timeFrame: 12 and 48 weeks from baseline
measure: Fasting lipoprotein (a)
timeFrame: 12 and 48 weeks from baseline
measure: Fasting triglycerides
timeFrame: 12 and 48 weeks from baseline
measure: Fasting non-HDL cholesterol
timeFrame: 12 and 48 weeks from baseline
Other outcomes:
measure: Fasting albumin
timeFrame: 12 and 48 weeks from baseline
measure: Fasting globulin
timeFrame: 12 and 48 weeks from baseline
measure: Fasting total bilirubin
timeFrame: 12 and 48 weeks from baseline
measure: Fasting alkaline phosphatase
timeFrame: 12 and 48 weeks from baseline
measure: Fasting aspartate aminotransferase
timeFrame: 12 and 48 weeks from baseline
measure: Fasting alanine aminotransferase
timeFrame: 12 and 48 weeks from baseline
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jonathan Little, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.