A Weight Loss RCT Comparing Keyto vs Weight Watchers

University of British Columbia

Status: Completed

Conditions: Ketogenic Diet; Overweight and Obesity

Treatments: Other: Weight Watchers app; Device: Keyto device + app

Study type: Interventional

Funder types: Other

Identifiers

NCT04165707

H19-01341

Details and patient eligibility

About

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.

Enrollment: 155 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 2 patient groups

Keyto intervention arm

Experimental group

Description:

Keyto device + app

Treatment:

Device: Keyto device + app

Weight Watchers comparator arm

Active Comparator group

Description:

Weight Watchers app

Treatment:

Other: Weight Watchers app