A Weight Loss RCT Comparing Keyto vs Weight Watchers

• Sponsor: University of British Columbia (Other)
• Overall Status: Completed
• CT.gov ID: NCT04165707
• Collaborator: (none)
• Enrollment: 155
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.1
• Patients Per Site Per Month: 7.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity; Ketogenic Diet	Device: Keyto device + app; Other: Weight Watchers app	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 155 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
• Actual Study Start Date: Dec 9, 2019
• Actual Primary Completion Date: Jan 2, 2021
• Actual Study Completion Date: Aug 11, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in body mass at 12 weeks [12 weeks from baseline]

   Change in body mass (in kilograms)

Secondary Outcome Measures

1. Change in body mass at 24 and 48 weeks [24 and 48 weeks from baseline]

   Change in body mass (in kilograms)

2. Carbohydrate intake [12, 24, and 48 weeks from baseline]

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

3. Total fat intake [12, 24, and 48 weeks from baseline]

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

4. Saturated fat intake [12, 24, and 48 weeks from baseline]

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

5. Polyunsaturated fat intake [12, 24, and 48 weeks from baseline]

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

6. Monounsaturated fat intake [12, 24, and 48 weeks from baseline]

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

7. Total energy intake [12, 24, and 48 weeks from baseline]

   Total energy intake in 24 hour period (in kilocalories)

8. HbA1C [12 and 48 weeks from baseline]

   Blood test will be used to determine changes in HbA1C

9. Fasting glucose [12 and 48 weeks from baseline]

   Blood test will be used to determine changes in fasting serum glucose

10. Fasting insulin [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 [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) [12 and 48 weeks from baseline]

    Blood test will be used to determine changes in HOMA-IR

13. Fasting total cholesterol [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 [12 and 48 weeks from baseline]

    Blood test will be used to determine changes in serum HDL cholesterol

15. Fasting lipoprotein fractions [12 and 48 weeks from baseline]

    Blood test will determine changes in serum lipoprotein fractions measured by ion mobility

16. Fasting lipoprotein (a) [12 and 48 weeks from baseline]

    Blood test will determine changes in serum lipoprotein (a)

17. Fasting triglycerides [12 and 48 weeks from baseline]

    Blood test will determine changes in serum trigylcerides

18. Fasting non-HDL cholesterol [12 and 48 weeks from baseline]

    Blood test will determine changes in serum non-HDL cholesterol

Other Outcome Measures

1. Fasting albumin [12 and 48 weeks from baseline]

   Blood test will determine changes in serum albumin

2. Fasting globulin [12 and 48 weeks from baseline]

   Blood test will determine changes in serum globulin

3. Fasting total bilirubin [12 and 48 weeks from baseline]

   Blood test will determine changes in serum bilirubin

4. Fasting alkaline phosphatase [12 and 48 weeks from baseline]

   Blood test will determine changes in serum alkaline phosphatase

5. Fasting aspartate aminotransferase [12 and 48 weeks from baseline]

   Blood test will determine changes in serum aspartate aminotransferase

6. Fasting alanine aminotransferase [12 and 48 weeks from baseline]

   Blood test will determine changes in serum alanine aminotransferase

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of British Columbia	Kelowna	British Columbia	Canada	V1V 1V7

Sponsors and Collaborators

• University of British Columbia

Investigators

• Principal Investigator: Jonathan Little, PhD, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jonathan Little, Assistant Professor, University of British Columbia
• ClinicalTrials.gov Identifier: NCT04165707
• Other Study ID Numbers: H19-01341
• First Posted: Nov 18, 2019
• Last Update Posted: Aug 26, 2021
• Last Verified: Aug 1, 2021

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

Study Results

No Results Posted as of Aug 26, 2021