Clinical trial NCT06972381: Piloting a Patient Navigator Program for Weight Loss
Official title: Piloting a Patient Navigator Program to Facilitate Uptake and Persistence With Evidence-based Weight Loss Interventions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Overweight
Keywords: weight loss
overweight
obesity
patient navigator
weight loss counselor
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-05-15
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm, randomized controlled pilot trial. Participants will be assigned to either the navigator condition or usual care, with a 1:1 allocation
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion criteria include:

* BMI \> 27 kg/m2
* weight \< 396 pounds due to limits of the wireless scale
* age 18 to 75
* ability to read and speak English sufficiently to engage with a counselor and complete study measures
* willing to be randomized to either study condition
* willing to engage with a counselor for assistance in identifying and initiating a weight loss intervention
* successfully complete enrollment and assessments tasks, including connecting a wireless scale for baseline measurement of weight
* reliable access to a device capable of using email and Drexel approved videoconferencing software
* residing in the greater Philadelphia metropolitan area, which includes Southeastern PA, Southern NJ, Northeast MD, and Northern DE
* agree that they will not join another intervention study in the WELL Center in the next 12 months

Exclusion criteria include:

* a medical or psychiatric condition that may a) limit appropriateness of weight loss intervention or b) be likely to cause a change in weight in the next 12 months (e.g., anorexia nervosa, bulimia nervosa, end-stage kidney disease, some types of cancer)
* currently taking weight loss medication or engaging in any other form of weight management intervention
* history of bariatric surgery
* a calculated weight suppression value of 10% or higher
* currently pregnant or planning to become pregnant in the next 12 months
* adults unable to consent, children, pregnant women, and prisoners

Primary outcomes:
measure: Percent weight change
timeFrame: 0 month, 6 month, 12 month
Secondary outcomes:
measure: 5% weight change
timeFrame: 0, 6, 12 months
measure: Recruitment feasibility
timeFrame: Throughout the 7 month recruitment and enrollment period
measure: Retention feasibility
timeFrame: 6, 12 months
measure: Intervention Acceptability
timeFrame: 6 month, 12 month
measure: Intervention engagement
timeFrame: 0-12 months
measure: Intervention fidelity
timeFrame: 0-12 months
measure: Utilization of Weight Change Interventions
timeFrame: 6 month, 12 month
measure: Qualitative Feedback
timeFrame: 6 month, 12 month
Other outcomes:
measure: Participant characteristics
timeFrame: 0 month
measure: Weight change history
timeFrame: 0 months
measure: Comorbidities Checklist
timeFrame: 0 month
measure: Attitudes toward weight change treatments
timeFrame: 0 months
measure: Interest in evidence-based weight loss options
timeFrame: 0 months
measure: Ambivalence
timeFrame: 0, 6, 12 months
measure: Attitude toward weight management medications
timeFrame: 0, 6, 12 months
measure: Barriers to weight loss medication adherence and uptake
timeFrame: 0, 6, 12 months
measure: MATCH
timeFrame: 0, 6, 12 months
measure: Multidimensional trust in healthcare systems
timeFrame: 0, 6, 12 months
measure: Beliefs and perspectives on obesity
timeFrame: 0, 6, 12 months
measure: All Aspects of Health Literacy Scale (AAHLS)
timeFrame: 0, 6, 12 months
Locations:
city: Philadelphia
country: United States
facility: Drexel university
state: Pennsylvania
Study officials:
References: