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Protocol for a pilot RCT investigating a weight loss navigation program for adults

Year: 2025

Type: article

Abstract: Millions of adults in the U.S. with overweight or obesity would like to improve their health via weight loss, yet utilization of evidence-based weight loss interventions is low. Instead, adults commonly attempt self-guided weight loss, which has poor efficacy. When adults use evidence-based interventions (i.e., behavioral, dietary, commercial, surgical, and pharmacological options), long-term engagement is suboptimal. The proposed project is a pilot randomized clinical trial to test the use of patient navigators to increase uptake of and persistence with evidence-based weight loss interventions. Navigators have been successful in other areas of healthcare to facilitate engagement with various treatment and prevention services. However, little data are available on the feasibility, acceptability, or efficacy of a weight loss navigator program in adults. In the present study, participants (N = 68 adults with a BMI >27 kg/m2 interested in weight loss) will be randomly assigned for a 12-month period to either usual care or the navigator condition. Participants in usual care will have no intervention contact, while participants in the navigator condition will attend individual sessions and receive personalized emails from a navigator to support uptake and persistence with an evidence-based weight loss intervention. Assessments will be conducted remotely at months 0, 6, and 12. The primary outcome for the preliminary test of efficacy is weight change after 12 months. This study will inform future iterations of a weight loss navigator program and could impact clinical practice and public health by enhancing the utilization of evidence-based weight loss interventions.

Source: Contemporary Clinical Trials

DOI: 10.1016/j.cct.2025.108163