Cargando…
Comparing the Keyto App and Device with Weight Watchers’ WW App for Weight Loss: Protocol for a Randomized Trial
BACKGROUND: Obesity and being overweight are major contributing factors for many diseases. Calorie restricted diets often fail to result in sustained long-term weight loss. Very low–carbohydrate, high-fat ketogenic diets have been suggested to have superior metabolic and weight loss effects. Keyto i...
Autores principales: | , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7459429/ https://www.ncbi.nlm.nih.gov/pubmed/32804087 http://dx.doi.org/10.2196/19053 |
_version_ | 1783576372418969600 |
---|---|
author | Locke, Sean R Falkenhain, Kaja Lowe, Dylan A Lee, Terry Singer, Joel Weiss, Ethan J Little, Jonathan P |
author_facet | Locke, Sean R Falkenhain, Kaja Lowe, Dylan A Lee, Terry Singer, Joel Weiss, Ethan J Little, Jonathan P |
author_sort | Locke, Sean R |
collection | PubMed |
description | BACKGROUND: Obesity and being overweight are major contributing factors for many diseases. Calorie restricted diets often fail to result in sustained long-term weight loss. Very low–carbohydrate, high-fat ketogenic diets have been suggested to have superior metabolic and weight loss effects. Keyto is a low-cost, highly scalable mobile health (mHealth) app paired with a noninvasive biofeedback tool aimed at facilitating weight loss through a personalized healthy and predominantly plant- and fish-based ketogenic diet. OBJECTIVE: This protocol describes a randomized trial comparing the efficacy of the Keyto mHealth app and device intervention to that of Weight Watchers’ WW app in individuals who are overweight or obese. The primary outcome is weight loss after 12 weeks. Secondary and exploratory outcomes, including metabolic and cardiovascular risk factors, will be assessed at 12, 24, and 48 weeks. METHODS: A total of 144 participants will be recruited and randomized to either the Keyto program or Weight Watchers program. Study participants will be guided through the study via video conference or phone calls and will undergo a fasting blood analysis performed by a third-party diagnostic lab at weeks 0 and 12 to assess metabolic and cardiovascular risk markers. All participants will be asked to weigh themselves daily on a study-provided Bluetooth-enabled scale. Participants randomized to the Keyto arm will also be asked to measure their breath acetone levels, a measure of ketosis, with the Keyto device 3 times per day. RESULTS: Recruitment started in December 2019. Rolling recruitment is expected to be completed by July 2020. Data collection and analysis of the primary intervention phase is expected to be completed in October 2020. The 24- and 48-week follow-ups are expected to be completed in January 2021 and July 2021, respectively. CONCLUSIONS: This trial will provide high-quality evidence regarding the efficacy of the Keyto weight loss program in individuals who are overweight and obese in a free-living condition. This study also fills a gap by examining the impact of a ketogenic diet emphasizing plant- and fish-based fats on blood lipid profile and cardiovascular disease risk. TRIAL REGISTRATION: ClinicalTrials.gov NCT04165707; https://clinicaltrials.gov/ct2/show/NCT04165707. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19053 |
format | Online Article Text |
id | pubmed-7459429 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | JMIR Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-74594292020-09-03 Comparing the Keyto App and Device with Weight Watchers’ WW App for Weight Loss: Protocol for a Randomized Trial Locke, Sean R Falkenhain, Kaja Lowe, Dylan A Lee, Terry Singer, Joel Weiss, Ethan J Little, Jonathan P JMIR Res Protoc Protocol BACKGROUND: Obesity and being overweight are major contributing factors for many diseases. Calorie restricted diets often fail to result in sustained long-term weight loss. Very low–carbohydrate, high-fat ketogenic diets have been suggested to have superior metabolic and weight loss effects. Keyto is a low-cost, highly scalable mobile health (mHealth) app paired with a noninvasive biofeedback tool aimed at facilitating weight loss through a personalized healthy and predominantly plant- and fish-based ketogenic diet. OBJECTIVE: This protocol describes a randomized trial comparing the efficacy of the Keyto mHealth app and device intervention to that of Weight Watchers’ WW app in individuals who are overweight or obese. The primary outcome is weight loss after 12 weeks. Secondary and exploratory outcomes, including metabolic and cardiovascular risk factors, will be assessed at 12, 24, and 48 weeks. METHODS: A total of 144 participants will be recruited and randomized to either the Keyto program or Weight Watchers program. Study participants will be guided through the study via video conference or phone calls and will undergo a fasting blood analysis performed by a third-party diagnostic lab at weeks 0 and 12 to assess metabolic and cardiovascular risk markers. All participants will be asked to weigh themselves daily on a study-provided Bluetooth-enabled scale. Participants randomized to the Keyto arm will also be asked to measure their breath acetone levels, a measure of ketosis, with the Keyto device 3 times per day. RESULTS: Recruitment started in December 2019. Rolling recruitment is expected to be completed by July 2020. Data collection and analysis of the primary intervention phase is expected to be completed in October 2020. The 24- and 48-week follow-ups are expected to be completed in January 2021 and July 2021, respectively. CONCLUSIONS: This trial will provide high-quality evidence regarding the efficacy of the Keyto weight loss program in individuals who are overweight and obese in a free-living condition. This study also fills a gap by examining the impact of a ketogenic diet emphasizing plant- and fish-based fats on blood lipid profile and cardiovascular disease risk. TRIAL REGISTRATION: ClinicalTrials.gov NCT04165707; https://clinicaltrials.gov/ct2/show/NCT04165707. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19053 JMIR Publications 2020-08-17 /pmc/articles/PMC7459429/ /pubmed/32804087 http://dx.doi.org/10.2196/19053 Text en ©Sean R Locke, Kaja Falkenhain, Dylan A Lowe, Terry Lee, Joel Singer, Ethan J Weiss, Jonathan P Little. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 17.08.2020. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included. |
spellingShingle | Protocol Locke, Sean R Falkenhain, Kaja Lowe, Dylan A Lee, Terry Singer, Joel Weiss, Ethan J Little, Jonathan P Comparing the Keyto App and Device with Weight Watchers’ WW App for Weight Loss: Protocol for a Randomized Trial |
title | Comparing the Keyto App and Device with Weight Watchers’ WW App for Weight Loss: Protocol for a Randomized Trial |
title_full | Comparing the Keyto App and Device with Weight Watchers’ WW App for Weight Loss: Protocol for a Randomized Trial |
title_fullStr | Comparing the Keyto App and Device with Weight Watchers’ WW App for Weight Loss: Protocol for a Randomized Trial |
title_full_unstemmed | Comparing the Keyto App and Device with Weight Watchers’ WW App for Weight Loss: Protocol for a Randomized Trial |
title_short | Comparing the Keyto App and Device with Weight Watchers’ WW App for Weight Loss: Protocol for a Randomized Trial |
title_sort | comparing the keyto app and device with weight watchers’ ww app for weight loss: protocol for a randomized trial |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7459429/ https://www.ncbi.nlm.nih.gov/pubmed/32804087 http://dx.doi.org/10.2196/19053 |
work_keys_str_mv | AT lockeseanr comparingthekeytoappanddevicewithweightwatcherswwappforweightlossprotocolforarandomizedtrial AT falkenhainkaja comparingthekeytoappanddevicewithweightwatcherswwappforweightlossprotocolforarandomizedtrial AT lowedylana comparingthekeytoappanddevicewithweightwatcherswwappforweightlossprotocolforarandomizedtrial AT leeterry comparingthekeytoappanddevicewithweightwatcherswwappforweightlossprotocolforarandomizedtrial AT singerjoel comparingthekeytoappanddevicewithweightwatcherswwappforweightlossprotocolforarandomizedtrial AT weissethanj comparingthekeytoappanddevicewithweightwatcherswwappforweightlossprotocolforarandomizedtrial AT littlejonathanp comparingthekeytoappanddevicewithweightwatcherswwappforweightlossprotocolforarandomizedtrial |