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Behavioral Intervention
Patient Navigators for Obesity
N/A
Waitlist Available
Led By Lorna McNeill
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether patient navigators can help obese people manage their weight better.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on informational and telephone-based interventions rather than medications or medical procedures, there are no direct side effects associated with the interventions being studied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in participant enrollment in evidence-based weight management programs
Secondary study objectives
Measurement of fruit and vegetable consumption
Objectively measured weight change.
Participant attendance or use of evidence-based weight management programs
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telephone-Based Intervention
2017
Completed Phase 2
~3400
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,073 Previous Clinical Trials
1,803,156 Total Patients Enrolled
9 Trials studying Obesity
2,347 Patients Enrolled for Obesity
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,111,926 Total Patients Enrolled
50 Trials studying Obesity
32,097 Patients Enrolled for Obesity
Lorna McNeillPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
1,474 Total Patients Enrolled
2 Trials studying Obesity
1,320 Patients Enrolled for Obesity