ObesityNCT06972381
Piloting a Patient Navigator Program for Weight Loss
A study testing Navigator in people with Obesity and Overweight, run by Drexel University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Piloting a Patient Navigator Program to Facilitate Uptake and Persistence With Evidence-based Weight Loss Interventions
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.
Read the 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
- Being tested
- Navigator
- Keywords
- weight loss, overweight, obesity, patient navigator, weight loss counselor
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavigatorBehavioural
Also called Weight loss counselor
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 0 month, 6 month, 12 month
Secondary outcomes (8)
5% weight change
The proportion of participants who have >5% weight loss (which is a standard threshold for clinical significance) will be a secondary outcome.
Measured: 0, 6, 12 months
Recruitment feasibility
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.
Measured: Throughout the 7 month recruitment and enrollment period
Retention feasibility
Data on retention will be available via REDCap. The benchmark is to retain a minimum of 75% of participants at 6 and 12 months.
Measured: 6, 12 months
Intervention Acceptability
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.
Measured: 6 month, 12 month
Intervention engagement
Attendance will be recorded in REDCap, so that the proportion of participants attending 4 or more sessions can be calculated (benchmark = 75%).
Measured: 0-12 months
Intervention fidelity
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.
Measured: 0-12 months
Utilization of Weight Change Interventions
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.
Measured: 6 month, 12 month
Qualitative Feedback
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.
Measured: 6 month, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start15 Sep 2025
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meghan Butryn, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972381
- Sponsor's protocol ID
- R01DK140184
- Status last verified
- Jan 2026
- First submitted
- 1 May 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Identifiable data will be de-identified prior to submission in the public repository to protect research participant privacy and confidentiality. All individual-participant level data will be preserved and shared, as all variables collected are pertinent to scientific questions.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Patient Navigator Program to Facilitate Uptake and Persistence With Evidence-based Weight Loss Interventions
- ClinicalTrials.gov ID
- NCT06972381
- Acronym / sponsor ID
- R01DK140184
- Conditions
- Obesity, Overweight
- Keywords
- weight loss, overweight, obesity, patient navigator, weight loss counselor
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Navigator Intervention | Experimental | Behavioral: NavigatorParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NavigatorAlso: Weight loss counselorParticipants 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. | Behavioural | Navigator Intervention |
Primary outcome
Percent weight change
Time frame: 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).
8 secondary outcomes
5% weight change
Time frame: 0, 6, 12 months
Recruitment feasibility
Time frame: Throughout the 7 month recruitment and enrollment period
Retention feasibility
Time frame: 6, 12 months
Intervention Acceptability
Time frame: 6 month, 12 month
Intervention engagement
Time frame: 0-12 months
Intervention fidelity
Time frame: 0-12 months
Utilization of Weight Change Interventions
Time frame: 6 month, 12 month
Qualitative Feedback
Time frame: 6 month, 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Yes. Identifiable data will be de-identified prior to submission in the public repository to protect research participant privacy and confidentiality. All individual-participant level data will be preserved and shared, as all variables collected are pertinent to scientific questions.
Related trials for Obesity
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Recruiting
Confident Moves Intervention Efficacy Trial: Obesity Care Settings
Obesity, Overweight
Not yet recruiting
Stearic Acid and Endothelial Function
Healthy Middle-aged Subjects, Obesity & Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigator in people with Obesity and Overweight, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent weight change (time frame: 0 month, 6 month, 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.