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Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery

Study acronym: PROJECT-BARI
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion pushed from Apr 30, 2027 to Jul 31, 2027 Completion pushed from Jul 31, 2027 to Jan 31, 2028 · Site contact updatedv6 Show 2 more changesShow less
    • Completion pushed from Jul 31, 2027 to Jan 31, 2028
    • Site contact updated
  2. Minor Primary completion date: Apr 2, 2027 to Apr 30, 2027 Site contact updatedv5 Show 1 more changeShow less
    • Site contact updated
  3. Minor Study description shortened, about 6 words Eligibility criteria shortened, about 2 wordsv4 Show 1 more changeShow less
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Re-verified, no change to tracked fieldsv3
  5. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 10, 2023 to Aug 29, 2023 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Aug 10, 2023 to Aug 29, 2023
    • Site details revised
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a randomized controlled trial employing a Sequential Multiple Assignment Randomized Trial (SMART) design to test whether pharmacotherapy, in conjunction with lifestyle counseling, can reverse weight regain after bariatric surgery.
Trial Details
NCT Number NCT05975580
Lead Sponsor University of California, Irvine
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Obesity
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov