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Behavioral Treatment + Medication for Obesity
Phase 4
Waitlist Available
Led By Jena S Tronieri, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI ≥ 31 kg/m² (or 28 kg/m2 with obesity-related comorbidity)
Age ≥ 21 years and ≤ 70 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Study Summary
This study is evaluating whether a combination of weight loss medication and behavioral therapy will help individuals lose more weight than behavioral therapy alone.
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 ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acetaminophen
Phase 1: Baseline postprandial change in GLP-1 during a test meal
Phase 1: Baseline satiety, as measured by visual analogue scales (range 0-100 mm) during a test meal; satiety quotient = [(fasting rating before preload - 60 min post-preload rating)] / (energy content of preload) x 100.
+3 moreSecondary outcome measures
Phase 1: Baseline delay discounting (computer task), area under the curve representing the ratio of immediate reward size to time delay
Phase 1: Baseline fasting ghrelin
Phase 1: Baseline fasting leptin
+12 moreOther outcome measures
Phase 1: Baseline Perceived Stress Scale
Phase 1: Baseline SCI Exercise Self Efficacy Scale (ESES)
Phase 1: Baseline Weight Efficacy Life-Style Questionnaire (WEL)
+25 moreTrial Design
2Treatment groups
Active Control
Group I: Behavioral Treatment + PlaceboActive Control2 Interventions
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Group II: Behavioral Treatment + MedicationActive Control2 Interventions
All participants will complete an initial 4-week behavioral treatment (BT) run-in. Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period.
Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
1,994 Previous Clinical Trials
42,879,109 Total Patients Enrolled
87 Trials studying Obesity
72,320 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,348 Previous Clinical Trials
4,314,585 Total Patients Enrolled
444 Trials studying Obesity
588,448 Patients Enrolled for Obesity
Jena S Tronieri, PhDPrincipal InvestigatorPerelman School of Medicine at the University of Pennsylvania
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