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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | HALO | Health 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. |
| BEHAVIORAL | Enhanced Standard of Care | The 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.