Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Behavioral: HALO
* Behavioral: Enhanced Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment versus enhanced standard of care
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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<br>* 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.<br>|
| Active Comparator: Enhanced Standard of Care<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Child dietary intake (mother-reported) will be assessed by a registered dietician via 3 scheduled 24-hour phone recalls (2 weekdays, 1 weekend) over a 2 week period using a multiple pass method. | 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 | Child dietary intake (mother-reported) will be assessed by a registered dietician via 3 scheduled 24-hour phone recalls (2 weekdays, 1 weekend) over a 2 week period using a multiple pass method. | 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) | Child minutes of moderate to vigorous physical activity will be assessed via a waist-worn actigraph accelerometer for 7 days, with data processed via validated scoring protocols | 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) | Child minutes of moderate to vigorous physical activity will be assessed via a waist-worn actigraph accelerometer for 7 days, with data processed via validated scoring protocols | 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) | Mothers will complete the Child Feeding Questionaire with validated scale scores in the areas of restriction, pressure to eat, perceived responsibility, and monitoring. Items are rated on a 5-point Likert scale, with subscales scored as the average. Higher scores indicate greater use of each feeding strategy. | baseline to 26 weeks (post-treatment) | 
| 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) | Mothers will complete the Child Feeding Questionaire with validated scale scores in the areas of restriction, pressure to eat, perceived responsibility, and monitoring. Items are rated on a 5-point Likert scale, with subscales scored as the average. Higher scores indicate greater use of each feeding strategy. | baseline to 52 weeks (6-month follow-up post-treatment) | 
| Secondary - Change in child hours of screen time from baseline to 26 weeks (post-treatment) | Mother-report of her child's leisure-time spent on a typical week-day using 3 types of screens (TV, computer/video-games, internet/electronic media). | baseline to 26 weeks (post-treatment) | 
| Secondary - Change in child hours of screen time from baseline to 52 weeks (6-month follow-up) | Mother-report of her child's leisure-time spent on a typical week-day using 3 types of screens (TV, computer/video-games, internet/electronic media). | baseline to 52 weeks (6-month follow-up post-treatment) | 
| 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) | Trained assessors will conduct an open home food inventory. Assessors record the presence of food or beverage items (size and quantity) located in the kitchen and secondary food storage areas (e.g., pantry, basement refrigerator). Foods/beverages without indication of size on packaging will be weighed. Full package size for partially consumed items will be recorded. | baseline to 26 weeks (post-treatment) | 
| 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) | Trained assessors will conduct an open home food inventory. Assessors record the presence of food or beverage items (size and quantity) located in the kitchen and secondary food storage areas (e.g., pantry, basement refrigerator). Foods/beverages without indication of size on packaging will be weighed. Full package size for partially consumed items will be recorded. | baseline to 52 weeks (6-month follow-up post-treatment) | 
| Secondary - Change in mother use of encouragement/modeling from baseline to 26 weeks (post-treatment) | Scale from the Neighborhood Impact on Kids Study will be used to assess 7 healthful eating behaviors (i.e., fruits, vegetables, low-fat snacks). Each item is rated on a Likert scale from 1 (never) to 5 (always), with the average taken across the 7 items. Higher scores mean more healthful modeling. | baseline to 26 weeks (post-treatment) | 
| Secondary - Change in mother use of encouragement/modeling from baseline to 52 weeks (6-month follow-up) | Scale from the Neighborhood Impact on Kids Study will be used to assess 7 healthful eating behaviors (i.e., fruits, vegetables, low-fat snacks). Each item is rated on a Likert scale from 1 (never) to 5 (always), with the average taken across the 7 items. Higher scores mean more healthful modeling. | baseline to 52 weeks (6-month follow-up post-treatment) |