NCT06972381

Piloting a Patient Navigator Program for Weight Loss

Piloting a Patient Navigator Program to Facilitate Uptake and Persistence With Evidence-based Weight Loss Interventions

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Drexel University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Evidence-based interventions for overweight and obesity are underutilized. The utilization and efficacy of these interventions may improve with the implementation of a patient navigator program, as has been practiced in other fields (e.g., cancer). The proposed study will enroll adults ("index participants") (N=68) with overweight/obesity in a 12-month program in which they will be provided with a navigator who will help them understand their options for evidence-based weight loss intervention and who will promote initiation and continued engagement with an intervention option. The project will provide information about how well received the navigator program is and the extent to which it works as expected.

Detailed description

Most adults who attempt weight loss do not use evidence-based interventions; instead, they engage in self-directed dieting, which is typically short-lived and has poor efficacy. These individuals often a) feel overwhelmed by navigating other options in the challenging climate of the U.S. healthcare system, b) lack knowledge about the costs, availability, efficacy and features of various interventions, and c) feel ambivalent about committing to a more structured weight loss approach. This pilot clinical trial is designed to test the use of a weight loss navigation program to address these problems. In the proposed study, participants (N = 68) will be adults with a BMI \> 27 kg/m2, recruited from the community, who are interested in weight loss. Participants will be randomized to either the navigator program or usual care. Usual care will have no intervention contact. Participants in the navigator condition will have 12 months of contact with their assigned counselor. Participants will be asked to attend a minimum of 5 sessions with the counselor conducted via videoconferencing software: two sessions in Month 1, one in Month 2, one in Month 4, and one in Month 8. Three additional sessions can be held at any time if the counselor and participant agree the additional contact would be helpful. Participants and navigators will also maintain contact via email outside of sessions. The navigator's goal will be to connect the participant with another provider or program who can directly deliver a form of evidence-based treatment to the participant (i.e., select commercial programs, behavioral weight loss, counseling from a licensed clinician, prescription medications and bariatric surgery), but the navigator will not be attempting to deliver any of those five evidence-based interventions themself. Navigators will assess treatment preferences, provide information about evidence-based treatment options for weight loss, aid in decision making, and facilitate action during the intervention initiation process. Outcomes will be measured at months 0, 6, and 12 months. The primary aim is determining if weight loss is higher in the navigator condition. Secondary aims include assessing the feasibility and acceptability of this pilot study and gathering feedback to improve the navigator program for future research. The current study will be a major contribution to the literature, as no evidence is available yet to understand the utility of a navigator program for treatment of overweight and obesity. This program has the potential to make a major public health impact by connecting many more of the millions of adults who could benefit from weight loss intervention with currently available, evidence-based tools.

Conditions

• Obesity
• Overweight

Interventions

Type	Name	Description
BEHAVIORAL	Navigator	Participants in the navigator condition will meet with their counselor for sessions twice in month 1, once in month 2, once in month 4, and once in month 8. Three additional sessions may scheduled if desired by the participant. Navigators will assess treatment preferences, provide information about evidence-based treatment options for weight loss, aid in decision making, and facilitate action during the intervention initiation process. Following initiation of a weight loss treatment, navigators will also assess adherence to and acceptability of the selected weight loss intervention, and engage in problem solving and motivational enhancement to facilitate persistence with the original intervention or provide the support necessary for switching to an alternative intervention option. Additional intervention contact will include monthly emails over the 12 month period. Navigators will receive resource guides to help them tailor sessions to the individual participant.

Timeline

• Start date: 2025-09-15
• Primary completion: 2027-02-15
• Completion: 2027-02-15
• First posted: 2025-05-15
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States