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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
35
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.
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
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
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
Time frame: 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
Time frame: baseline to 52 weeks (6-month follow-up 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 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.
Time frame: 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.
Time frame: 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)
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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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline to 52 weeks (6-month follow-up post-treatment)