RECRUITING
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Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery
This is the Phase 2 pilot/feasibility randomized controlled trial of HALO (Health And Lifestyle Behaviors In Offspring), a parent-led behavioral intervention targeting a high-risk pediatric population (i.e., residing offspring ages 6-12; body mass index \> the 70th and \< 120% of the 95th percentiles of mothers with severe obesity) that is uniquely well-timed, when mothers are highly engaged in behavior change and losing weight during the first year following bariatric surgery.
Conditions:
🦠 Obesity, Childhood
🗓️ Study Start (Actual) 14 March 2022
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 50
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Cincinnati, Ohio, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Female caregivers with a biological child (either sex) aged 6-12 years
    • * Caregiver is 3-12 months post undergoing a non-device based bariatric surgical procedure
    • * Caregiver is able to read, write, and speak in English
    • * Child has a BMI \> the 70th and \< 120% of the 95th percentile
    • * Child not currently engaged in weight management (behavioral, pharmacologic)
    • * Child has no chronic medical conditions or developmental disabilities
    • * Child resides in her home \> 75% of the time
    • * Child is willing to participate

    Exclusion Criteria:

    • * Female caregiver is not pregnant at time of enrollment
    • * Must not live \>75 miles from Cincinnati Children's Hospital Main Campus.
    • * Child BMI is \> 120% of the 95th percentile
Ages Eligible for Study: 6 Years to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 22 April 2022
  • First Submitted that Met QC Criteria 22 April 2022
  • First Posted 28 April 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 July 2023
  • Last Update Posted 10 July 2023
  • Last Verified July 2023
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