A Weight Loss RCT Comparing Keyto vs Weight Watchers

University of British Columbia155 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

155

Conditions

Overweight and Obesity Ketogenic Diet

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in body mass at 12 weeks

Change in body mass (in kilograms)

Time frame: 12 weeks from baseline

Secondary Outcomes

Change in body mass at 24 and 48 weeks

Change in body mass (in kilograms)

Time frame: 24 and 48 weeks from baseline

Carbohydrate intake

Total consumption of carbohydrates in 24 hour period (in grams)

Time frame: 12, 24, and 48 weeks from baseline

Total fat intake

Total consumption of fat in 24 hour period (in grams)

Time frame: 12, 24, and 48 weeks from baseline

Saturated fat intake

Total consumption of saturated fat in 24 hour period (in grams)

Time frame: 12, 24, and 48 weeks from baseline

Polyunsaturated fat intake

Total consumption of polyunsaturated fat in 24 hour period (in grams)

Time frame: 12, 24, and 48 weeks from baseline

Monounsaturated fat intake

Total consumption of monounsaturated fat in 24 hour period (in grams)

Time frame: 12, 24, and 48 weeks from baseline

Total energy intake

Total energy intake in 24 hour period (in kilocalories)

Time frame: 12, 24, and 48 weeks from baseline

HbA1C

Blood test will be used to determine changes in HbA1C