Piloting a Patient Navigator Program for Weight Loss

NCT06972381 | Active Not Recruiting

• 1 other identifier: R01DK140184
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent weight change

  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).

  0 month, 6 month, 12 month

Secondary Outcomes (8)

• 5% weight change

  0, 6, 12 months

• Recruitment feasibility

  Throughout the 7 month recruitment and enrollment period

• Retention feasibility

  6, 12 months

• Intervention Acceptability

  6 month, 12 month

• Intervention engagement

  0-12 months

Other Outcomes (13)

• Participant characteristics

  0 month

• Weight change history

  0 months

• Comorbidities Checklist

  0 month

Study Arms (2)

Navigator Intervention

EXPERIMENTAL

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.

Behavioral: Navigator

Usual Care

NO INTERVENTION

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.

Interventions

Navigator 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.

Also known as: Weight loss counselor

Navigator Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Drexel university

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be blind to condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 15, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: In accordance with NCI policy, the scientific data will be shared within 12 months of trial completion. Any data included in associated manuscripts will be available at the time of publication; all other scientific data will be shared no later than the end of the award performance period. The study data will be stored in the repository for at least 10 years after the end of the funding period.
• Access Criteria: There are no anticipated factors or limitations on access, distribution, or reuse of the scientific data from this proposal. We will address data management and sharing processes during the informed consent process, and all research participants will be consented for broad data sharing of de-identified data.

Locations

US (1)