A Weight Loss RCT Comparing Keyto vs Weight Watchers

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial Comparing Weight Loss Effects Between the Keyto Virtual Ketogenic Diet Program Compared to a Standard-care Weight Loss App

Conditions
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Overweight and Obesity, Ketogenic Diet

Intervention / Treatment
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* Device: Keyto device + app
* Other: Weight Watchers app


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Keyto intervention arm<br>Keyto device + app | Device: Keyto device + app<br>* 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.<br>|
| Active Comparator: Weight Watchers comparator arm<br>Weight Watchers app | Other: Weight Watchers app<br>* The Weight Watchers app helps people to monitor their food intake, track points and provides recipe ideas to support weight loss.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass at 12 weeks | Change in body mass (in kilograms) | 12 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass at 24 and 48 weeks | Change in body mass (in kilograms) | 24 and 48 weeks from baseline | 
| Carbohydrate intake | Total consumption of carbohydrates in 24 hour period (in grams) | 12, 24, and 48 weeks from baseline | 
| Total fat intake | Total consumption of fat in 24 hour period (in grams) | 12, 24, and 48 weeks from baseline | 
| Saturated fat intake | Total consumption of saturated fat in 24 hour period (in grams) | 12, 24, and 48 weeks from baseline | 
| Polyunsaturated fat intake | Total consumption of polyunsaturated fat in 24 hour period (in grams) | 12, 24, and 48 weeks from baseline | 
| Monounsaturated fat intake | Total consumption of monounsaturated fat in 24 hour period (in grams) | 12, 24, and 48 weeks from baseline | 
| Total energy intake | Total energy intake in 24 hour period (in kilocalories) | 12, 24, and 48 weeks from baseline | 
| HbA1C | Blood test will be used to determine changes in HbA1C | 12 and 48 weeks from baseline | 
| Fasting glucose | Blood test will be used to determine changes in fasting serum glucose | 12 and 48 weeks from baseline | 
| Fasting insulin | Blood test will be used to determine changes in fasting serum insulin | 12 and 48 weeks from baseline | 
| Fasting high-sensitivity C-reactive protein | Blood test will be used to determine changes in fasting serum high-sensitivity C-reactive protein | 12 and 48 weeks from baseline | 
| Fasting homeostasis model assessment of insulin resistance (HOMA-IR) | Blood test will be used to determine changes in HOMA-IR | 12 and 48 weeks from baseline | 
| Fasting total cholesterol | Blood test will be used to determine changes in serum total cholesterol | 12 and 48 weeks from baseline | 
| Fasting high-density lipoprotein (HDL) cholesterol | Blood test will be used to determine changes in serum HDL cholesterol | 12 and 48 weeks from baseline | 
| Fasting lipoprotein fractions | Blood test will determine changes in serum lipoprotein fractions measured by ion mobility | 12 and 48 weeks from baseline | 
| Fasting lipoprotein (a) | Blood test will determine changes in serum lipoprotein (a) | 12 and 48 weeks from baseline | 
| Fasting triglycerides | Blood test will determine changes in serum trigylcerides | 12 and 48 weeks from baseline | 
| Fasting non-HDL cholesterol | Blood test will determine changes in serum non-HDL cholesterol | 12 and 48 weeks from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet, weight loss, ketogenic diet, low carbohydrate