Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery

NCT05350267 | Completed

• 1 other identifier: 2021-0601
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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 (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

Outcome Measures

Primary Outcomes (2)

• Preliminary Efficacy - Change in child body mass index standardized for age/sex from baseline to 26 weeks (post-treatment)

  Trained assessors will measure child height/weight using a standardized protocol. These measurements will be converted to body mass index (kg/m\^2) and then standardized by child age and sex

  baseline to 26 weeks (post-treatment)

• Preliminary Efficacy - Change in child body mass index standardized for age/sex from baseline to 52 weeks (6-month follow-up)

  Trained assessors will measure child height/weight using a standardized protocol. These measurements will be converted to body mass index (kg/m\^2) and then standardized by child age and sex

  baseline to 52 weeks (6-month follow-up post-treatment)

Secondary Outcomes (12)

• Secondary - Change in child daily intake of total kcals, and kcals from red foods, sugar-sweetened beverages, and fruits and vegetables from baseline to 26 weeks (post-treatment) using a 3-day dietary recall

  baseline to 26 weeks (post-treatment)

• Secondary - Change in child daily intake of total kcals, and kcals from red foods, sugar-sweetened beverages, and fruits and vegetables from baseline to 52 weeks (6-month follow-up) using a 3-day dietary recall

  baseline to 52 weeks (6-month follow-up post-treatment)

• Secondary - Change in child minutes of moderate to vigorous physical activity (MVPA) from baseline to 26 weeks (post-treatment)

  baseline to 26 weeks (post-treatment)

• Secondary - Change in child minutes of moderate to vigorous physical activity (MVPA) from baseline to 52 weeks (6-month follow-up)

  baseline to 52 weeks (6-month follow-up post-treatment)

• Secondary - Change in mother-reported child feeding practices of restriction, pressure to eat, perceived responsibility, and monitoring from baseline to 26 weeks (post-treatment)

  baseline to 26 weeks (post-treatment)

Other Outcomes (12)

• Change in maternal percent weight loss and body mass index from baseline to 26 weeks (post-treatment)

  baseline to 26 weeks (post-treatment)

• Change in maternal percent weight loss and body mass index from baseline to 52 weeks (6-month follow-up)

  baseline to 52 weeks (6-month follow-up post-treatment)

• Change in maternal total kcals from baseline to 26 weeks (post-treatment) using a 3-day dietary recall

  baseline to 26 weeks (post-treatment)

Study Arms (2)

Treatment

EXPERIMENTAL

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.

Behavioral: HALO

Enhanced Standard of Care

ACTIVE COMPARATOR

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

Behavioral: Enhanced Standard of Care

Interventions

HALO BEHAVIORAL

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.

Treatment

Enhanced Standard of Care BEHAVIORAL

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

Enhanced Standard of Care

Eligibility Criteria

• Age: 6 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• University of Delaware: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Margaret H Zeller, PhD

  Cincinnati Chidren's Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment versus enhanced standard of care

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: March 14, 2022
• Primary Completion: March 10, 2025
• Study Completion: March 19, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 12 months following completion of the study
• Access Criteria: PI will provide information

Locations

US (1)