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

Area of Science:

• Obesity and Weight Management
• Health Services Research
• Behavioral Medicine

Background:

• Low utilization and suboptimal long-term engagement characterize evidence-based weight loss interventions for adults with overweight or obesity.
• Self-guided weight loss attempts often lack efficacy.
• Patient navigators show promise in improving healthcare engagement but their role in weight management is understudied.

Purpose of the Study:

• To pilot a randomized clinical trial evaluating patient navigators for increasing uptake and persistence with evidence-based weight loss interventions.
• To assess the feasibility, acceptability, and preliminary efficacy of a weight loss navigator program.
• To inform future weight management program development and clinical practice.

Main Methods:

• A 12-month pilot randomized clinical trial involving 68 adults with a BMI >27 kg/m2 interested in weight loss.
• Participants were randomized to either usual care or a navigator condition.
• The navigator condition included individual sessions and personalized emails to support intervention engagement. Remote assessments occurred at 0, 6, and 12 months.

Main Results:

• The primary outcome is weight change after 12 months, with preliminary efficacy data pending.
• The study will provide data on the feasibility and acceptability of the navigator intervention.
• Analysis will focus on differences in weight change between the navigator and usual care groups.

Conclusions:

• Patient navigators represent a potential strategy to enhance engagement with evidence-based weight loss interventions.
• This pilot study's findings will guide the refinement of navigator programs for adults seeking weight loss.
• Successful implementation could improve public health by increasing adherence to effective weight management strategies.