Patient Navigator Program for Obesity

Overseen By Meghan L Butryn, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Must not be taking: Weight loss medication

Disqualifiers: Anorexia, Bulimia, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12 months

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a patient navigator program can help individuals with overweight or obesity better utilize weight loss treatments. Participants will either receive support from a navigator to guide them through weight loss options or continue with their usual care. The trial aims to determine if a navigator makes it easier to adhere to a weight loss plan. Suitable candidates for this trial include those with a BMI over 27, residing in the greater Philadelphia area, and not currently using weight loss medications or other interventions. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance weight loss support systems.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on weight loss medication or any weight management intervention to participate.

What prior data suggests that this patient navigator program is safe for weight loss interventions?

Research shows that patient navigator programs are generally easy to use. Past studies have helped individuals make informed decisions about weight loss options, with no major reports of negative effects from using navigators in these situations.

Patient navigators aim to help people start and stick with proven weight loss methods. Evidence indicates that programs with navigators can lead to successful weight loss, with many participants losing at least 5% of their body weight. This amount of weight loss is linked to lower health risks related to obesity.

Overall, using navigators in weight loss programs appears safe and can be a useful tool for those wanting to manage their weight effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Navigator program for obesity because it offers a personalized support system that differs from standard weight loss treatments like diet plans, medications, or surgery. Unlike these options, the Navigator program provides participants with a dedicated weight loss counselor, or "navigator," who offers continuous guidance and motivation through regular video calls and emails over a year. This unique approach focuses on supporting individuals to stick to evidence-based weight loss strategies rather than prescribing a specific diet or exercise regimen. By fostering a strong, supportive relationship, the program aims to enhance adherence to healthy lifestyle changes, potentially leading to more successful long-term weight management.

What evidence suggests that the Navigator program is effective for obesity?

Research has shown that programs with patient navigators can significantly aid weight loss. In this trial, participants in the Navigator Intervention arm will receive support from a weight loss counselor, or navigator, over a 12-month period. One study found that individuals using a weight navigation program lost significantly more weight than those without such support. On average, participants lost 4.4% of their body weight, while those without a navigator lost almost no weight. This program also increased the likelihood of losing at least 5% or even 10% of body weight. Navigators guide patients through their weight loss options and support them in following their chosen plan. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with overweight or obesity issues. It's designed to help them understand and stick with weight loss programs. Specific eligibility details aren't provided, so it seems open to individuals who meet the general condition of having a weight management concern.

Inclusion Criteria

Reliable access to a device capable of using email and Drexel approved videoconferencing software

Agree that they will not join another intervention study in the WELL Center in the next 12 months

Successfully complete enrollment and assessments tasks, including connecting a wireless scale for baseline measurement of weight

Exclusion Criteria

A calculated weight suppression value of 10% or higher

Currently pregnant or planning to become pregnant in the next 12 months

I am currently using weight loss medication or other weight management methods.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive guidance from a navigator to initiate and adhere to an evidence-based weight loss intervention over 12 months

12 months

5-8 sessions via videoconferencing, monthly email contact

Follow-up

Participants are monitored for weight change and program acceptability

12 months

Assessments at 0, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Navigator

Trial Overview The study tests a 'navigator' program over 12 months where participants are guided by a navigator to engage in evidence-based weight loss interventions and maintain their commitment.

How Is the Trial Designed?

Group I: Navigator Intervention Experimental Treatment 1 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 II: Usual Care Active Control 1 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 Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11161489

Piloting a patient navigator program to facilitate ... - NIH RePORTER The proposed project is designed to test the use of patient navigators to increase uptake of and persistence with evidence-based weight loss interventions.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06972381

Piloting a Patient Navigator Program for Weight Loss Navigators will assess treatment preferences, provide information about evidence-based treatment options for weight loss, aid in decision making, and facilitate ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818868

A Primary Care–Based Weight Navigation Program In addition, patients in the WNP lost significantly more weight (−4.4% vs −0.1%) and had greater odds of achieving 5% or more and 10% or more ...

4. taggs.hhs.gov taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=R01DK140184&arg_ProgOfficeCode=119

Award Information | HHS TAGGS Piloting a patient navigator program to facilitate uptake and persistence with evidence-based weight loss interventions. Award Number: R01DK140184 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0738399123005128

A patient-centered evaluation of a novel medical student- ... This was a cross-sectional study assessing patients' subjective experience of medical student navigators for rheumatological conditions.

6. reporter.nih.gov reporter.nih.gov/search/bCJpoAhZoE2AAlcrv59AEA/project-details/11161489

Project Details - NIH RePORTER The proposed project is designed to test the use of patient navigators to increase uptake of and persistence with evidence-based weight loss interventions.

7. ihpi.umich.edu ihpi.umich.edu/news-events/news/adding-obesity-experts-primary-care-clinics-improves-patients-weight-loss-outcomes

Adding obesity experts to primary care clinics improves ... Over 40% of those in the WNP lost at least 5% of their body weight, a goal that's been shown to reduce obesity-related health risks. In ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11109771/

A Primary Care–Based Weight Navigation Program - PMC Primary outcomes were feasibility measures, including rates of referral to and engagement in the WNP. Secondary outcomes were mean weight loss, ...

9. withpower.com withpower.com/trial/patient-navigator-program-for-obesity-d2b73

Patient Navigator Program for Obesity This N/A medical study run by Drexel University is evaluating whether Navigator will have tolerable side effects & efficacy for patients with Weight Loss, ...