Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial.
dietary adherence
just-in-time adaptive intervention
microrandomized trial
mobile phone
obesity
weight loss
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
06 Dec 2021
06 Dec 2021
Historique:
received:
21
09
2021
accepted:
28
09
2021
entrez:
7
12
2021
pubmed:
8
12
2021
medline:
8
12
2021
Statut:
epublish
Résumé
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. 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. 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. The recruitment for the microrandomized trial began on April 19, 2021, and is ongoing. 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). ClinicalTrials.gov NCT04784585; http://clinicaltrials.gov/ct2/show/NCT04784585. DERR1-10.2196/33568.
Sections du résumé
BACKGROUND
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
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
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
RESULTS
The recruitment for the microrandomized trial began on April 19, 2021, and is ongoing.
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov NCT04784585; http://clinicaltrials.gov/ct2/show/NCT04784585.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/33568.
Identifiants
pubmed: 34874892
pii: v10i12e33568
doi: 10.2196/33568
pmc: PMC8691411
doi:
Banques de données
ClinicalTrials.gov
['NCT04784585']
Types de publication
Journal Article
Langues
eng
Pagination
e33568Subventions
Organisme : NHLBI NIH HHS
ID : R01 HL153543
Pays : United States
Informations de copyright
©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.
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