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

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          Abstract

          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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          Most cited references103

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          The Physical Activity Guidelines for Americans

          Approximately 80% of US adults and adolescents are insufficiently active. Physical activity fosters normal growth and development and can make people feel, function, and sleep better and reduce risk of many chronic diseases.
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            Ecological Momentary Assessment

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              Is Open Access

              Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support

              Background The just-in-time adaptive intervention (JITAI) is an intervention design aiming to provide the right type/amount of support, at the right time, by adapting to an individual’s changing internal and contextual state. The availability of increasingly powerful mobile and sensing technologies underpins the use of JITAIs to support health behavior, as in such a setting an individual’s state can change rapidly, unexpectedly, and in his/her natural environment. Purpose Despite the increasing use and appeal of JITAIs, a major gap exists between the growing technological capabilities for delivering JITAIs and research on the development and evaluation of these interventions. Many JITAIs have been developed with minimal use of empirical evidence, theory, or accepted treatment guidelines. Here, we take an essential first step towards bridging this gap. Methods Building on health behavior theories and the extant literature on JITAIs, we clarify the scientific motivation for JITAIs, define their fundamental components, and highlight design principles related to these components. Examples of JITAIs from various domains of health behavior research are used for illustration. Conclusions As we enter a new era of technological capacity for delivering JITAIs, it is critical that researchers develop sophisticated and nuanced health behavior theories capable of guiding the construction of such interventions. Particular attention has to be given to better understanding the implications of providing timely and ecologically sound support for intervention adherence and retention We clarify the scientific motivation for the Just-In-Time Adaptive Interventions, define its fundamental components, and discuss key design principles for each component.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                December 2021
                6 December 2021
                : 10
                : 12
                : e33568
                Affiliations
                [1 ] Weight Control and Diabetes Research Center The Miriam Hospital Providence, RI United States
                [2 ] Department of Psychiatry and Human Behavior Alpert Medical School of Brown University Providence, RI United States
                [3 ] Department of Psychology Drexel University Philadelphia, PA United States
                [4 ] School of Information University of Michigan Ann Arbor, MI United States
                [5 ] Holcombe Department of Electrical and Computer Engineering Clemson University Clemson, SC United States
                Author notes
                Corresponding Author: Stephanie P. Goldstein stephanie_goldstein@ 123456brown.edu
                Author information
                https://orcid.org/0000-0002-9656-1675
                https://orcid.org/0000-0003-2736-2303
                https://orcid.org/0000-0002-4570-703X
                https://orcid.org/0000-0003-2965-6524
                https://orcid.org/0000-0002-0918-8252
                https://orcid.org/0000-0001-7549-2431
                Article
                v10i12e33568
                10.2196/33568
                8691411
                34874892
                90af7f6c-98f9-4dfd-8e98-1757034d9d10
                ©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.

                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.

                History
                : 21 September 2021
                : 28 September 2021
                Categories
                Protocol
                Protocol
                Custom metadata
                This paper was externally peer reviewed by Psychosocial Risk and Disease Prevention Study Section (National Institutes of Health). See Multimedia Appendix 1 for the peer-review report;

                obesity,weight loss,dietary adherence,just-in-time adaptive intervention,microrandomized trial,mobile phone

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