Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery
- Conditions
- Obesity, Childhood
- Interventions
- Behavioral: Enhanced Standard of CareBehavioral: HALO
- Registration Number
- NCT05350267
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced Standard of Care 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 Treatment HALO 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.
- Primary Outcome Measures
Name Time Method Preliminary Efficacy - Change in child body mass index standardized for age/sex from baseline to 26 weeks (post-treatment) 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
Preliminary Efficacy - Change in child body mass index standardized for age/sex from baseline to 52 weeks (6-month follow-up) baseline to 52 weeks (6-month follow-up 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
- Secondary Outcome Measures
Name Time Method 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) 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.
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) 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
Secondary - Change in child hours of screen time from baseline to 26 weeks (post-treatment) 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).
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) 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.
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) 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
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) 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.
Secondary - Change in mother use of encouragement/modeling from baseline to 26 weeks (post-treatment) 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.
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) baseline to 52 weeks (6-month follow-up 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.
Secondary - Change in child hours of screen time from baseline to 52 weeks (6-month follow-up) baseline to 52 weeks (6-month follow-up 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).
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) 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.
Secondary - Change in mother use of encouragement/modeling from baseline to 52 weeks (6-month follow-up) baseline to 52 weeks (6-month follow-up 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.
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) baseline to 52 weeks (6-month follow-up 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.
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States