Clinical Trials Directory

Trials / Completed

CompletedNCT05350267

Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Children's Hospital Medical Center, Cincinnati · Academic / Other
Sex
Female
Age
6 Years
Healthy volunteers
Not accepted

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 (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

Interventions

TypeNameDescription
BEHAVIORALHALOHealth and Lifestyle Behaviors in Offspring, or "HALO" is designed for mothers who recently had bariatric surgery who have a school-aged child. HALO focuses on providing each mother with education and parenting strategies to improve her child's healthy lifestyle behaviors, such as her child's eating and physical activity, while she is engaged in her own lifestyle behavior change after bariatric surgery.
BEHAVIORALEnhanced Standard of CareThe comparator group will receive monthly mailings of publicly available and age-appropriate handouts on healthy eating, physical activity, screen time, and healthy sleep habits

Timeline

Start date
2022-03-14
Primary completion
2025-03-10
Completion
2025-03-19
First posted
2022-04-28
Last updated
2025-11-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05350267. Inclusion in this directory is not an endorsement.