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Pilot Feasibility Stud ; 10(1): 40, 2024 Feb 26.
Article in English | MEDLINE | ID: mdl-38409075

ABSTRACT

BACKGROUND: Even without weight loss, adults with obesity can greatly benefit from regular physical activity. The Physical Activity Self-efficacy (PAS) intervention is an online behavioral intervention newly developed to promote physical activity in adults with obesity by providing capability-enhancing learning opportunities. The objective of this manuscript is to describe the protocol for a feasibility study designed to investigate the feasibility and acceptability of implementing the PAS online intervention for adults with obesity recruited from a local weight management center in the United States of America (USA). METHODS: The study design is a prospective, double-blind, parallel-group individual randomized pilot trial. Thirty participants will be randomly assigned to the PAS group or usual care group to achieve a 1:1 group assignment. Recruitment of participants is scheduled to begin on 1 March 2024 at a local weight management center within a private healthcare system in the USA. There are six eligibility criteria for participation in this study (e.g., a body mass index ≥ 25.00 kg/m2). Eligibility verification and data collection will be conducted online. Three waves of data collection will take up to 14 weeks depending on participants' progress in the study. The primary feasibility outcomes in the study will be: (a) participation rate, (b) engagement behavior, and (c) a preliminary effect size estimate for the effect of the PAS intervention on physical activity. Instruments designed to measure demographic information, anthropometric characteristics, self-efficacy, and acceptability will be included in the survey battery. A research-grade accelerometer will be used to measure free-living physical activity objectively. Data will be analyzed using descriptive statistics and inferential statistical models under an intention-to-treat approach. DISCUSSION: Results are intended to inform the preparation of a future definitive randomized controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05935111, registered 7 July 2023.

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