Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery (HALO-2)

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Obesity, Childhood

Treatments: Behavioral: HALO; Behavioral: Enhanced Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05350267

2021-0601

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: Female

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups

Treatment

Experimental group

Description:

HALO is a mixed-delivery intervention (online learning, digital technologies, telehealth visits) co-designed with mothers that (a) uniquely tailors intervention content to integrate post-bariatric surgery guidelines to recommendations to reduce child obesity risk, (b) teaches mothers evidence-based parenting behaviors to support intergenerational lifestyle and home food environment changes, and (c) addresses unique barriers to family-level change identified by mothers post-bariatric surgery.

Treatment:

Behavioral: HALO

Enhanced Standard of Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Enhanced Standard of Care