171 Participants Needed

Patient Navigators for Obesity

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial studies the effectiveness of patient navigators in facilitating weight management in obese participants. Health coaches or patient navigators may help more participants take part in weight management programs.

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 data supports the effectiveness of this treatment?

Research shows that patient navigators, originally developed for cancer care, help improve treatment engagement and health outcomes, especially for ethnic minority groups. They provide logistic and emotional support, which can be beneficial in managing chronic conditions like obesity by helping patients access necessary care and resources.12345

How is the Patient Navigators treatment for obesity different from other treatments?

Patient Navigators for obesity are unique because they involve trained individuals who help patients overcome barriers to accessing healthcare, rather than focusing on medication or direct medical interventions. This approach is adapted from successful models in cancer care and mental health, where navigators have improved treatment engagement and health outcomes by providing personalized guidance and support.16789

Research Team

Lorna H. McNeill | MD Anderson Cancer ...

Lorna McNeill

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.)
See 2 more

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
See 3 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (information, call from patient navigator)Experimental Treatment3 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 Control2 Interventions
Participants receive information about commercially-available weight management programs and encouragement to participate in one of the programs for 6 months.

Find a Clinic Near You

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+

Findings from Research

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

References

Peer navigators and integrated care to address ethnic health disparities of people with serious mental illness. [2022]
Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: a multi-site patient navigation research program study. [2022]
Patient navigation (PN) support to timely access to radiotherapy in the Brazilian public health system. [2023]
Translating the patient navigator approach to meet the needs of primary care. [2022]
Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life. [2021]
Patient navigators facilitating access to primary care: a scoping review. [2019]
Increasing Mental Health Engagement From Primary Care: The Potential Role of Family Navigation. [2020]
Navigating to health: Evaluation of a community health center patient navigation program. [2020]
Evolution of a health navigator model of care within a primary care setting: a case study. [2013]