Piloting a Patient Navigator Program for Weight Loss

Not Applicable

Not yet recruiting

• Conditions: Obesity; Overweight

• Registration Number: NCT06972381
• Lead Sponsor: Drexel University

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-01
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15
• Study Start: 2025-07
• Primary Completion: 2027-02-15
• Study Completion: 2027-02-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent weight change	0 month, 6 month, 12 month	Participants will be instructed to use a Withings wireless scale (stated accuracy to 0.1 kg) to weigh themselves. Participants will be instructed to step on the scale in the morning (before eating but after using the bathroom), wearing no shoes and minimal clothing, with the scale on a hard, flat, surface. Participants will be instructed to measure their weight for three consecutive days so that a participant's mean can be calculated at each time point in order to minimize the influence of daily fluctuations of weight. Data will be pulled from the Withings cloud to the study database via the Withings API. In order to maximize accuracy, we will remove errant weights (e.g., \>1 kg change in 1 day).

Secondary Outcome Measures

Name	Time	Method
5% weight change	0, 6, 12 months	The proportion of participants who have \>5% weight loss (which is a standard threshold for clinical significance) will be a secondary outcome.
Intervention fidelity	0-12 months	To assess the feasibility of navigators having fidelity to their assigned intervention approaches, a structured rubric will be created to code 10% of audio- or videorecorded sessions and 10% of emails. Sessions and emails will be randomly selected for review. The rubric will outline ratings for adhering to principles of the intervention approach as well as ratings for contamination. Each item in the rubric will be rated on a 1-10 scale, with 10 showing perfect fidelity. The benchmark of mean score of 8 or higher was chosen based on face validity.
Recruitment feasibility	Throughout the 7 month recruitment and enrollment period	Data on recruitment rate will be available via REDCap. The benchmark is to enroll \~10 participants per month over the course of the 7-month recruitment period.
Utilization of Weight Change Interventions	6 month, 12 month	A structured interview, conducted by a blinded member of the research staff, will query which types of weight change interventions have been utilized in the previous 6 months, as well as the length of intervention engagement. De-identified data will be coded. Each intervention reported by a participant will be categorized as a specific type of evidence-based intervention (nutritional counseling, behavioral counseling, select commercial programs, pharmacotherapy, or bariatric surgery) or a type of non-evidence-based intervention (e.g., self-guided weight loss attempt, use of herbal supplements, etc.). A categorical variable will capture whether or not the participant received an evidence-based intervention in the previous 6 months. A continuous measure also will indicate the number of weeks in the previous 6 months in which the the participant reported active use of an evidence-based intervention.
Retention feasibility	6, 12 months	Data on retention will be available via REDCap. The benchmark is to retain a minimum of 75% of participants at 6 and 12 months.
Intervention Acceptability	6 month, 12 month	Participants in the Navigator condition will be administered the Treatment Acceptability Questionnaire at 6 and 12 months, with content modified as needed to be clear that the items are referring to the navigator program, not any other weight loss intervention the participant may be receiving. This measure has six items, each rated on a 1-7 scale, with 7 being most positive. The benchmark of mean score of 5 or greater in the navigator condition was chosen based on face validity to correspond to ratings that are positive, as opposed to negative or neutral.
Intervention engagement	0-12 months	Attendance will be recorded in REDCap, so that the proportion of participants attending 4 or more sessions can be calculated (benchmark = 75%).
Qualitative Feedback	6 month, 12 month	Semi-structured interviews (30 minutes each) will be conducted by trained team members at months 6 and 12 to inform improvements in the navigator program for future research. These qualitative data will be collected from 10 program participants in the Navigator condition. Participants will be purposively sampled across personal characteristics (e.g., age, gender), process (adherence, satisfaction), and outcome metrics (utilization of weight loss interventions, weight) to ensure diverse perspectives and insights. Interviews will explore a) acceptability of research and intervention procedures, and b) factors that hinder or facilitate adherence and weight loss. Participant will be offered an additional $25 for each interview.

Trial Locations

Locations (1)

Drexel university; 🇺🇸 Philadelphia, Pennsylvania, United States