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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Keyto intervention arm | Experimental | Keyto device + app |
|
| Weight Watchers comparator arm | Active Comparator | Weight Watchers app |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Keyto device + app | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass at 12 weeks | Change in body mass (in kilograms) | 12 weeks from baseline |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting albumin | Blood test will determine changes in serum albumin | 12 and 48 weeks from baseline |
| Fasting globulin | Blood test will determine changes in serum globulin |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Little, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Kelowna | British Columbia | V1V 1V7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41356752 | Derived | Falkenhain K, Lowe DA, Locke SR, Singer J, Weiss EJ, Little JP. Long-Term Weight Loss in Adults With Overweight or Obesity Using a Breath Biofeedback mHealth App: A One-Year Follow-Up of a Randomized Trial. Obes Sci Pract. 2025 Dec 5;11(6):e70106. doi: 10.1002/osp4.70106. eCollection 2025 Dec. | |
| 38375882 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 19, 2022 | |
| Reset | Jan 20, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 19, 2022 | Jan 20, 2023 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Weight Watchers app | Other | The Weight Watchers app helps people to monitor their food intake, track points and provides recipe ideas to support weight loss. |
|
| 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 |
| 12 and 48 weeks from baseline |
| Fasting total bilirubin | Blood test will determine changes in serum bilirubin | 12 and 48 weeks from baseline |
| Fasting alkaline phosphatase | Blood test will determine changes in serum alkaline phosphatase | 12 and 48 weeks from baseline |
| Fasting aspartate aminotransferase | Blood test will determine changes in serum aspartate aminotransferase | 12 and 48 weeks from baseline |
| Fasting alanine aminotransferase | Blood test will determine changes in serum alanine aminotransferase | 12 and 48 weeks from baseline |
| Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2. |
| 35285809 | Derived | 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. |
| 32804087 | Derived | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |