Status:
COMPLETED
Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
University of Delaware
Conditions:
Obesity, Childhood
Eligibility:
FEMALE
6+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05350267
Start Date
March 14 2022
End Date
March 19 2025
Last Update
November 14 2025
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229