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Anti-obesity agent
Counselling for Obesity
Phase 4
Waitlist Available
Led By Trina M Aguirre
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Overweight/Obese Adult patients (age 19 years -65)
eligible based on WALI screening tool
Timeline
Screening 3 weeks
Treatment Varies
Follow Up difference between baseline and 6 months
Awards & highlights
Study Summary
This trial is testing whether pharmacological therapy, individual motivational interviewing, or a combination of the two is more effective than usual care in improving outcome measures for obese people who test positive or negative for food addiction.
Eligible Conditions
- Obesity
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ difference between baseline and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~difference between baseline and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
body fat
weight
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: CounsellingExperimental Treatment2 Interventions
These participants will receive usual care and counseling in the form of motivational interviewing weekly with goal setting for the first 5 weeks and monthly intervention for the final 5 months.
Group II: Contrave and counselingExperimental Treatment4 Interventions
These participants will receive usual care of diet and physical activity recommendations and Contrave prescription and counseling (motivational interviewing interventions weekly for the first 5 weeks and then monthly for 5 months.
Group III: ContraveExperimental Treatment2 Interventions
These participants will receive usual care and prescription of Contrave for weight loss. They will be seen weekly for the first 5 weeks and monthly for the final 5 months.
Group IV: Intervention ControlActive Control1 Intervention
All participants will receive diet/physical intervention. One arm will receive diet/physical activity intervention alone as a Intervention/usual care condition.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intervention Control
2017
Completed Phase 4
~90
Naltrexone
FDA approved
Naltrexone
FDA approved
Counselling
2010
Completed Phase 4
~21150
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Who is running the clinical trial?
University of NebraskaLead Sponsor
535 Previous Clinical Trials
1,143,823 Total Patients Enrolled
10 Trials studying Obesity
3,366 Patients Enrolled for Obesity
Trina M AguirrePrincipal InvestigatorUniversity of Nebraska
Frequently Asked Questions
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