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Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial

BACKGROUND: Behavioral obesity treatment (BOT) is a gold standard approach to weight loss and reduces the risk of cardiovascular disease. However, frequent lapses from the recommended diet stymie weight loss and prevent individuals from actualizing the health benefits of BOT. There is a need for inn...

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Autores principales: Goldstein, Stephanie P, Zhang, Fengqing, Klasnja, Predrag, Hoover, Adam, Wing, Rena R, Thomas, John Graham
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8691411/
https://www.ncbi.nlm.nih.gov/pubmed/34874892
http://dx.doi.org/10.2196/33568
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author Goldstein, Stephanie P
Zhang, Fengqing
Klasnja, Predrag
Hoover, Adam
Wing, Rena R
Thomas, John Graham
author_facet Goldstein, Stephanie P
Zhang, Fengqing
Klasnja, Predrag
Hoover, Adam
Wing, Rena R
Thomas, John Graham
author_sort Goldstein, Stephanie P
collection PubMed
description BACKGROUND: Behavioral obesity treatment (BOT) is a gold standard approach to weight loss and reduces the risk of cardiovascular disease. However, frequent lapses from the recommended diet stymie weight loss and prevent individuals from actualizing the health benefits of BOT. There is a need for innovative treatment solutions to improve adherence to the prescribed diet in BOT. OBJECTIVE: The aim of this study is to optimize a smartphone-based just-in-time adaptive intervention (JITAI) that uses daily surveys to assess triggers for dietary lapses and deliver interventions when the risk of lapse is high. A microrandomized trial design will evaluate the efficacy of any interventions (ie, theory-driven or a generic alert to risk) on the proximal outcome of lapses during BOT, compare the effects of theory-driven interventions with generic risk alerts on the proximal outcome of lapse, and examine contextual moderators of interventions. METHODS: Adults with overweight or obesity and cardiovascular disease risk (n=159) will participate in a 6-month web-based BOT while using the JITAI to prevent dietary lapses. Each time the JITAI detects elevated lapse risk, the participant will be randomized to no intervention, a generic risk alert, or 1 of 4 theory-driven interventions (ie, enhanced education, building self-efficacy, fostering motivation, and improving self-regulation). The primary outcome will be the occurrence of lapse in the 2.5 hours following randomization. Contextual moderators of intervention efficacy will also be explored (eg, location and time of day). The data will inform an optimized JITAI that selects the theory-driven approach most likely to prevent lapses in a given moment. RESULTS: The recruitment for the microrandomized trial began on April 19, 2021, and is ongoing. CONCLUSIONS: This study will optimize a JITAI for dietary lapses so that it empirically tailors the provision of evidence-based intervention to the individual and context. The finalized JITAI will be evaluated for efficacy in a future randomized controlled trial of distal health outcomes (eg, weight loss). TRIAL REGISTRATION: ClinicalTrials.gov NCT04784585; http://clinicaltrials.gov/ct2/show/NCT04784585 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33568
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spelling pubmed-86914112022-01-10 Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial Goldstein, Stephanie P Zhang, Fengqing Klasnja, Predrag Hoover, Adam Wing, Rena R Thomas, John Graham JMIR Res Protoc Protocol BACKGROUND: Behavioral obesity treatment (BOT) is a gold standard approach to weight loss and reduces the risk of cardiovascular disease. However, frequent lapses from the recommended diet stymie weight loss and prevent individuals from actualizing the health benefits of BOT. There is a need for innovative treatment solutions to improve adherence to the prescribed diet in BOT. OBJECTIVE: The aim of this study is to optimize a smartphone-based just-in-time adaptive intervention (JITAI) that uses daily surveys to assess triggers for dietary lapses and deliver interventions when the risk of lapse is high. A microrandomized trial design will evaluate the efficacy of any interventions (ie, theory-driven or a generic alert to risk) on the proximal outcome of lapses during BOT, compare the effects of theory-driven interventions with generic risk alerts on the proximal outcome of lapse, and examine contextual moderators of interventions. METHODS: Adults with overweight or obesity and cardiovascular disease risk (n=159) will participate in a 6-month web-based BOT while using the JITAI to prevent dietary lapses. Each time the JITAI detects elevated lapse risk, the participant will be randomized to no intervention, a generic risk alert, or 1 of 4 theory-driven interventions (ie, enhanced education, building self-efficacy, fostering motivation, and improving self-regulation). The primary outcome will be the occurrence of lapse in the 2.5 hours following randomization. Contextual moderators of intervention efficacy will also be explored (eg, location and time of day). The data will inform an optimized JITAI that selects the theory-driven approach most likely to prevent lapses in a given moment. RESULTS: The recruitment for the microrandomized trial began on April 19, 2021, and is ongoing. CONCLUSIONS: This study will optimize a JITAI for dietary lapses so that it empirically tailors the provision of evidence-based intervention to the individual and context. The finalized JITAI will be evaluated for efficacy in a future randomized controlled trial of distal health outcomes (eg, weight loss). TRIAL REGISTRATION: ClinicalTrials.gov NCT04784585; http://clinicaltrials.gov/ct2/show/NCT04784585 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33568 JMIR Publications 2021-12-06 /pmc/articles/PMC8691411/ /pubmed/34874892 http://dx.doi.org/10.2196/33568 Text en ©Stephanie P Goldstein, Fengqing Zhang, Predrag Klasnja, Adam Hoover, Rena R Wing, John Graham Thomas. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 06.12.2021. 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 https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Goldstein, Stephanie P
Zhang, Fengqing
Klasnja, Predrag
Hoover, Adam
Wing, Rena R
Thomas, John Graham
Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial
title Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial
title_full Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial
title_fullStr Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial
title_full_unstemmed Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial
title_short Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial
title_sort optimizing a just-in-time adaptive intervention to improve dietary adherence in behavioral obesity treatment: protocol for a microrandomized trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8691411/
https://www.ncbi.nlm.nih.gov/pubmed/34874892
http://dx.doi.org/10.2196/33568
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