Clinical trial NCT05350267: Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery
Official title: Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: University of Delaware
First posted: 2022-04-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment versus enhanced standard of care
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Preliminary Efficacy - Change in child body mass index standardized for age/sex from baseline to 26 weeks (post-treatment)
timeFrame: baseline to 26 weeks (post-treatment)
measure: Preliminary Efficacy - Change in child body mass index standardized for age/sex from baseline to 52 weeks (6-month follow-up)
timeFrame: baseline to 52 weeks (6-month follow-up post-treatment)
Secondary outcomes:
measure: 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
timeFrame: baseline to 26 weeks (post-treatment)
measure: 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
timeFrame: baseline to 52 weeks (6-month follow-up post-treatment)
measure: Secondary - Change in child minutes of moderate to vigorous physical activity (MVPA) from baseline to 26 weeks (post-treatment)
timeFrame: baseline to 26 weeks (post-treatment)
measure: Secondary - Change in child minutes of moderate to vigorous physical activity (MVPA) from baseline to 52 weeks (6-month follow-up)
timeFrame: baseline to 52 weeks (6-month follow-up post-treatment)
measure: Secondary - Change in mother-reported child feeding practices of restriction, pressure to eat, perceived responsibility, and monitoring from baseline to 26 weeks (post-treatment)
timeFrame: baseline to 26 weeks (post-treatment)
measure: Secondary - Change in mother-reported child feeding practices of restriction, pressure to eat, perceived responsibility, and monitoring from baseline to 52 weeks (6-month follow-up)
timeFrame: baseline to 52 weeks (6-month follow-up post-treatment)
measure: Secondary - Change in child hours of screen time from baseline to 26 weeks (post-treatment)
timeFrame: baseline to 26 weeks (post-treatment)
measure: Secondary - Change in child hours of screen time from baseline to 52 weeks (6-month follow-up)
timeFrame: baseline to 52 weeks (6-month follow-up post-treatment)
measure: Secondary - Change in physical home food environment total kcals, and kcals from sugar-sweetened beverages, snack foods, fruits, and vegetables from baseline to 26 weeks (post-treatment)
timeFrame: baseline to 26 weeks (post-treatment)
measure: Secondary - Change in physical home food environment total kcals, and kcals from sugar-sweetened beverages, snack foods, fruits, and vegetables from baseline to 52 weeks (6-month follow-up)
timeFrame: baseline to 52 weeks (6-month follow-up post-treatment)
measure: Secondary - Change in mother use of encouragement/modeling from baseline to 26 weeks (post-treatment)
timeFrame: baseline to 26 weeks (post-treatment)
measure: Secondary - Change in mother use of encouragement/modeling from baseline to 52 weeks (6-month follow-up)
timeFrame: baseline to 52 weeks (6-month follow-up post-treatment)
Other outcomes:
measure: Change in maternal percent weight loss and body mass index from baseline to 26 weeks (post-treatment)
timeFrame: baseline to 26 weeks (post-treatment)
measure: Change in maternal percent weight loss and body mass index from baseline to 52 weeks (6-month follow-up)
timeFrame: baseline to 52 weeks (6-month follow-up post-treatment)
measure: Change in maternal total kcals from baseline to 26 weeks (post-treatment) using a 3-day dietary recall
timeFrame: baseline to 26 weeks (post-treatment)
measure: Change in maternal total kcals from baseline to 52 weeks (6-month follow-up) using a 3-day dietary recall
timeFrame: baseline to 52 weeks (6-month follow-up post-treatment)
measure: Change in mother's minutes of moderate to vigorous physical activity from baseline to 26 weeks (post-treatment)
timeFrame: baseline to 26 weeks (post-treatment)
measure: Change in mother's minutes of moderate to vigorous physical activity from baseline to 52 weeks (6-month follow-up)
timeFrame: baseline to 52 weeks (6-month follow-up post-treatment)
measure: Change in child emotional functioning from baseline to 26 weeks (post-treatment) using Sizing Me Up
timeFrame: baseline to 26 weeks (post-treatment)
measure: Change in child emotional functioning from baseline to 52 weeks (6-month follow-up) using Sizing Me Up
timeFrame: baseline to 52 weeks (6-month follow-up post-treatment)
measure: Attendance/Participation rates
timeFrame: baseline to 26 weeks (post-treatment) and 52 weeks (6-month follow-up)
measure: Implementation - Fidelity
timeFrame: baseline to 26 weeks (post-treatment)
measure: Implementation - Usability/Satisfaction
timeFrame: baseline to 26 weeks (post-treatment)
measure: Time needed for intervention
timeFrame: baseline to 26 weeks (post-treatment)
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Chidren's Hospital Medical Center
name: Margaret H Zeller, PhD
role: PRINCIPAL_INVESTIGATOR
References: