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

Stephanie P Goldstein, Fengqing Zhang, Predrag Klasnja, Adam Hoover, Rena R Wing, John Graham Thomas, Stephanie P Goldstein, Fengqing Zhang, Predrag Klasnja, Adam Hoover, Rena R Wing, John Graham Thomas

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; https://ichgcp.net/clinical-trials-registry/NCT04784585.

International registered report identifier (irrid): DERR1-10.2196/33568.

Keywords: dietary adherence; just-in-time adaptive intervention; microrandomized trial; mobile phone; obesity; weight loss.

Conflict of interest statement

Conflicts of Interest: JGT participated in a scientific advisory board and served as a paid consultant for Lumme Health.

©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.

Figures

Figure 1
Figure 1
Conceptual model of just-in-time adaptive intervention components. EMA: ecological momentary assessment; JITAI: just-in-time adaptive intervention.
Figure 2
Figure 2
The information-motivation-strategy model that informed the just-in-time adaptive intervention options.

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