Piloting a Patient Navigator Program for Weight Loss

NCT ID: NCT06972381

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2027-02-15

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.

Conditions

Obesity; Overweight

Keywords

weight loss; overweight; obesity; patient navigator; weight loss counselor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Navigator Intervention

Participants assigned to the navigator condition will receive a weight loss counselor who they will maintain contact with over the 12 month period. Participants will attend 5-8 videoconferencing sessions with their navigator, as well as communicate with them monthly via email for extra support. Navigators will help participants initiate and adhere to an evidence-based weight loss intervention, without providing the treatment themselves.

Group Type: EXPERIMENTAL

Navigator

Intervention Type: BEHAVIORAL

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.

Usual Care

Participants assigned to the usual care condition will have no intervention contact during the 12-month data collection period and are encouraged to use resources available to them in community and in their health care system to identify treatment options. They will be given the option to attend a two-hour educational workshop (on videoconferencing software) after the 12-month assessment, to learn more about evidence-based approaches to weight loss.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Weight loss counselor

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Meghan Butryn

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Drexel university

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Research Coordinator, BA

Role: CONTACT

Phone: 913-558-2078

Email: hs988@drexel.edu

Meghan L Butryn, PhD

Role: CONTACT

Phone: 215. 553.7108

Email: mlb34@drexel.edu

Facility Contacts

Hannah I Silverstein, BA

Role: primary

Meghan L Butryn, PhD

Role: backup

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DK140184

Identifier Type: NIH

Identifier Source: org_study_id

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