Patient Navigators for Obesity

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Recent weight loss, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether health coaches, known as patient navigators, can help people manage their weight more successfully. Participants will either receive information about weight management programs or additional support through phone calls from a patient navigator. This trial targets individuals with a BMI (a measure of body fat based on height and weight) between 30 and 45 who are not currently in a weight loss program and can engage in moderate exercise. As an unphased trial, this study provides a unique opportunity to explore innovative support methods for weight management.

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 participate if you are currently using weight loss medications.

What prior data suggests that patient navigators are safe for weight management?

Research shows that patient navigators are generally safe for participants. In past studies, patient navigators helped people manage health issues like obesity and diabetes, with no major safety concerns reported.

Patient navigators guide individuals through healthcare decisions, offering support, information, and encouragement. Participants in previous research have not reported significant negative effects. Instead, they often find the support helpful in managing their health.

Overall, evidence suggests that patient navigators are well-tolerated and help participants make healthier choices without added risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using patient navigators for obesity management because this approach adds a personal touch that standard treatments often lack. Unlike traditional methods that might solely provide information or medication, this strategy involves regular, personalized support from a patient navigator through phone calls. This method aims to keep participants motivated and accountable, which can be challenging with self-directed programs. By integrating behavioral support with existing weight management programs, researchers hope to enhance long-term success in managing obesity.

What evidence suggests that patient navigators are effective for weight management in obesity?

Studies have shown that patient navigators can effectively help people lose weight. In this trial, participants in Group II will receive information about commercially-available weight management programs and encouragement to participate in one for 6 months, along with 6 phone calls from an assigned patient navigator. Research indicates that these navigators provide personalized support and information, leading to better weight management results. Similar programs, known as system navigation programs, have successfully connected patients to helpful community resources, improving health outcomes. Overall, patient navigators show promise in making it easier for individuals to join and stick with weight loss programs. ^{3 6 7 8 9}

Who Is on the Research Team?

Lorna McNeill

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with obesity, defined as having a BMI between 30 and 45. Participants must have a working phone, mailing address, speak English, internet access, and be able to do moderate exercise. They should be referred by a UT health provider but can't join if they're pregnant or planning it, in another weight program or used weight loss drugs recently.

Inclusion Criteria

Have a body mass index (BMI) greater than or equal to 30 and less than or equal to 45 kg/m^2

Have a working telephone number and address where materials can be mailed

Internet access at home or other location (e.g., work, church, library, community center, etc.)

Exclusion Criteria

Another person in the same household already enrolled in the proposed intervention

Pregnant or thinking about becoming pregnant during the study period

Are already involved in another weight loss program

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive information about weight management programs and encouragement to participate for 6 months. Group II also receives 6 phone calls from a patient navigator.

6 months

6 phone calls (20-30 minutes each)

Follow-up

Participants are monitored for changes in enrollment, attendance, physical activity, diet, and weight after treatment

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient Navigators

Trial Overview The study tests if patient navigators (health coaches) help obese individuals engage more effectively in weight management programs. It involves receiving information, answering questionnaires and getting support through phone calls.

How Is the Trial Designed?

Group I: Group II (information, call from patient navigator) Experimental Treatment 3 Interventions

Participants receive information about commercially-available weight management programs encouragement to participate in one of the programs for 6 months. Participants also receive 6 phone calls over 20-30 minutes each from an assigned patient navigator for 6 months.

Group II: Group I (information about weight management programs) Active Control 2 Interventions

Participants receive information about commercially-available weight management programs and encouragement to participate in one of the programs for 6 months.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Patient navigation (PN) significantly reduced the time from biopsy to the start of radiotherapy (RT) in cancer patients in Brazil, decreasing the median time from 108 days to 74 days, which highlights its efficacy in improving access to timely treatment.

The PN program also shortened various time frames related to the treatment process, including referral to RT and the time from the first consultation to the end of RT, demonstrating its potential as a cost-effective solution to enhance cancer care in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation (PN) support to timely access to radiotherapy in the Brazilian public health system. Vieira, CM., Diniz, PHC., Dizon, DS., et al.[2023]

In a randomized controlled trial involving 319 patients with breast and colorectal cancer, patient navigation did not show a statistically significant effect on cancer-specific quality of life (QOL) compared to usual care.

While the emotional well-being of the patient navigation group showed a change that approached significance, overall QOL measures did not differ significantly, suggesting that patient navigation may not enhance QOL during cancer treatment in this study's context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life. Hendren, S., Griggs, JJ., Epstein, R., et al.[2021]

Many children with mental health issues are not receiving the help they need, and pediatric primary care clinics could be key places to identify and address these problems early.

Family navigators, who help families navigate the mental health system, show promise in improving engagement in mental health services for children, although more research is needed to fully understand their effectiveness in pediatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Mental Health Engagement From Primary Care: The Potential Role of Family Navigation. Godoy, L., Hodgkinson, S., Robertson, HA., et al.[2020]

Patient navigators can effectively connect individuals without a regular primary care source to healthcare providers, enhancing access to necessary medical services, as evidenced by a review of 20 studies.

Most studies emphasized patient-centred care principles, indicating that navigators not only facilitate connections but also promote a supportive healthcare environment that involves and informs patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigators facilitating access to primary care: a scoping review. Peart, A., Lewis, V., Brown, T., et al.[2019]

The Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I) measure was validated in a study involving 783 participants, demonstrating high internal consistency and reliability (α ranging from 0.95 to 0.96).

The PSN-I effectively captures patient satisfaction with navigators, showing strong correlations with existing satisfaction measures, which suggests it is a reliable tool for assessing the quality of support provided to underserved cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: a multi-site patient navigation research program study. Jean-Pierre, P., Fiscella, K., Winters, PC., et al.[2022]

Patient navigators, originally designed for cancer care, have shown promise in improving treatment engagement and health outcomes for ethnic minority groups, which could be beneficial for people of color with serious mental illnesses.

Research is currently exploring how peer navigators can enhance integrated psychiatric care for patients of color, potentially leading to better health outcomes in this underserved population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer navigators and integrated care to address ethnic health disparities of people with serious mental illness. Corrigan, PW., Pickett, S., Batia, K., et al.[2022]

The lay-led health navigator model in a rural New Zealand setting effectively supported vulnerable individuals facing multiple health barriers, demonstrating its importance in improving access to care in underserved areas.

Survey results indicated high satisfaction among users of the navigator service, highlighting its positive impact on connecting clients with health and social care services despite challenges in implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of a health navigator model of care within a primary care setting: a case study. Doolan-Noble, F., Smith, D., Gauld, R., et al.[2013]

The pilot study involved 75 elderly patients, primarily female, who received patient navigation services from a social worker, helping them effectively navigate the complex US healthcare system.

Patients reported finding the navigation services very helpful, and physicians recognized the PN as a valuable addition to the practice, indicating that integrating patient navigation into primary care can significantly benefit those with complex healthcare needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the patient navigator approach to meet the needs of primary care. Ferrante, JM., Cohen, DJ., Crosson, JC.[2022]

Citations

1. 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 ...

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

A Primary Care–Based Weight Navigation Program - PMC A primary care–based weight navigation program (WNP) support weight loss among patients with obesity through weight-focused consultation visits.

3. withpower.com withpower.com/trial/phase-6-2015-8c4c9

Patient Navigators for Obesity · Info for Participants This trial studies the effectiveness of patient navigators in facilitating weight management in obese participants. Health coaches or patient navigators may ...

4. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-023-09424-5

Effectiveness of system navigation programs linking primary ... This systematic review aims to identify the effectiveness of system navigation programs linking primary care with community-based health and social services.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/imhj.22075

Patient navigation models for mental health of parents ... Patient navigation (PN) aims to improve timely access to healthcare by helping patients to “navigate” complex service provision landscapes.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03382782

Peer Navigators to Address Obesity-Related Concerns for ... Investigators will analyze fidelity, process, outcome and impact data, including the effect of BWLI and BWLI and PN on weight, waist circumference, blood ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9543493/

Eliciting the mechanisms of action of care navigators in ... This study illustrates that having a care navigator in place empowers those with severe mental illness to improve the management of their diabetes.

8. withpower.com withpower.com/trial/phase-2-community-mental-health-services-2-2022-72044

Patient Navigators for Community Mental Health Services Research is currently exploring how peer navigators can enhance integrated psychiatric care for patients of color, potentially leading to better health outcomes ...

9. formative.jmir.org formative.jmir.org/2023/1/e42683

Predicting Social Determinants of Health in Patient Navigation In this formative study, we explored novel machine learning–based approaches to predict SDoHs in 2 Chicago area PN studies.