Acceptability and Preliminary Efficacy of a Novel Web-Based Physical Activity for the Heart (PATH) Intervention Designed to Promote Physical Activity in Adults With Obesity: Protocol for a Pilot Randomized Controlled Trial.

Background: Even in the absence of weight loss, any level of physical activity (PA) can reduce the risk of cardiovascular disease among individuals with obesity. However, these individuals face multifaceted barriers that reduce their motivation and engagement in PA. They prefer programs that are convenient, fun to engage in, and feature people who they can relate to. Yet, there is a paucity of PA interventions that are designed to incorporate these preferences. We designed the web-based PA for The Heart (PATH) intervention to address this gap.

Objective: This study aimed to describe the protocol of a study that aims to examine the acceptability and preliminary efficacy of PATH intervention among insufficiently active adults with obesity aged at least 18 years.

Methods: This is a 6-month pilot randomized controlled trial (RCT), using a parallel design with 1:1 allocation to intervention or control group. The PATH intervention group is given access to the PATH platform, but the resources each participant can access are tailored according to their baseline fitness level. Control group receives a self-help PA handout. Both groups self-monitor their PA using Fitbit (Google) and have Zoom (Zoom Video Communications) meetings twice a month with either the health coach (intervention) or study coordinator (control). The outcomes at 6-months include acceptability, changes in PA, and cardiometabolic risk from baseline to 6-months.

Results: We screened 763 individuals for eligibility and 89 participants were enrolled and randomized to the intervention (45/504, 50.6%) and control arms (44/504, 49.4%). The average age was 48.7 (SD 12.17) years, and most participants were female (81/504, 90.1%), Black (45/504, 50.6%), and non-Hispanic (83/504, 93.3%). No systematic differences in baseline characteristics were observed between the study arms. The 6-month intervention is currently underway, and the completion of follow-up data collection is expected in February 2025, with results to be published soon after.

Conclusions: The PATH intervention offers a promising, evidence-based approach to overcoming the barriers that have hindered previous PA programs for adults with obesity. It can support new and existing programs to foster long-term maintenance of health-enhancing PA.

Trial Registration: ClinicalTrials.gov NCT05803304; https://clinicaltrials.gov/study/NCT05803304.

International Registered Report Identifier (irrid): DERR1-10.2196/67972.