Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery

Obesity, Childhood Clinical Trial

— HALO-2  

Official title:

Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05350267
• Other study ID #: 2021-0601
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Margaret H Zeller, PhD
• Phone: 513-636-2712
• Email: meg.zeller[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• HALO
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.
• 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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in maternal percent weight loss and body mass index from baseline to 26 weeks (post-treatment)	Trained assessors will measure mothers' weight and height using a standardized protocol which will be used to calculate maternal percent weight loss and body mass index (kg/m^2).	baseline to 26 weeks (post-treatment)
Other	Change in maternal percent weight loss and body mass index from baseline to 52 weeks (6-month follow-up)	Trained assessors will measure mothers' weight and height using a standardized protocol which will be used to calculate maternal percent weight loss and body mass index (kg/m^2).	baseline to 52 weeks (6-month follow-up post-treatment)
Other	Change in maternal total kcals from baseline to 26 weeks (post-treatment) using a 3-day dietary recall	Mother-reported dietary intake will be assessed by a registered dietician via 3 scheduled 24-hour phone recalls (2 weekdays and 1 weekend) over a 2-week period using the multiple-pass method to measure total kcals.	baseline to 26 weeks (post-treatment)
Other	Change in maternal total kcals from baseline to 52 weeks (6-month follow-up) using a 3-day dietary recall	Mother-reported dietary intake will be assessed by a registered dietician via 3 scheduled 24-hour phone recalls (2 weekdays and 1 weekend) over a 2-week period using the multiple-pass method to measure total kcals.	baseline to 52 weeks (6-month follow-up post-treatment)
Other	Change in mother's minutes of moderate to vigorous physical activity from baseline to 26 weeks (post-treatment)	Mother 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)
Other	Change in mother's minutes of moderate to vigorous physical activity from baseline to 52 weeks (6-month follow-up)	Mother 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)
Other	Change in child emotional functioning from baseline to 26 weeks (post-treatment) using Sizing Me Up	Sizing Me Up is a child-reported weight-related quality of life measure validated for youth (ages 5-13) that assesses a child's thoughts and experiences in context of his/her "size". Lowered scores on the 4-item child emotional functioning subscale (how their size makes them feel [mad, sad, worried, and frustrated]) will be monitored. Raw scores will be transformed to a 0-100 scale, with higher scores representing better emotional functioning.	baseline to 26 weeks (post-treatment)
Other	Change in child emotional functioning from baseline to 52 weeks (6-month follow-up) using Sizing Me Up	Sizing Me Up is a child-reported weight-related quality of life measure validated for youth (ages 5-13) that assesses a child's thoughts and experiences in context of his/her "size". Lowered scores on the 4-item child emotional functioning subscale (how their size makes them feel [mad, sad, worried, and frustrated]) will be monitored. Raw scores will be transformed to a 0-100 scale, with higher scores representing better emotional functioning.	baseline to 52 weeks (6-month follow-up post-treatment)
Other	Attendance/Participation rates	Thresholds will be used as guides to evaluate whether study achieved goals (e.g., percent) for enrollment (at least 85 percent eligible approached), representativeness (at least 30 percent Non-White), retention (at least 80 percent mother/child dyads in treatment group complete 16-week intervention), and data completion (at least 80 percent complete all 3 assessements).	baseline to 26 weeks (post-treatment) and 52 weeks (6-month follow-up)
Other	Implementation - Fidelity	Thresholds will be used as guides to evaluate whether treatment arm delivered as intended. Fidelity checklists created specifically for each intervention session based on intervention manual.	baseline to 26 weeks (post-treatment)
Other	Implementation - Usability/Satisfaction	Thresholds will be used a guides to evaluate whether treatment arm mothers' ratings of content accessibility, acceptability, usability, and satisfaction of the HALO program via Likert ratings (Scale 1-5) with higher scores indicating greater usability and satisfaction. Thresholds are mean/item ratings greater than or equal to 4.	baseline to 26 weeks (post-treatment)
Other	Time needed for intervention	For the treatment arm. time will be assessed in three ways. Time stamp of time watching sessions videos will be recorded. Treatment sessions will be timed to determine average length of time needed. Number of weeks to complete all sessions will be tracked to determine the average length of time needed to execute intervention.	baseline to 26 weeks (post-treatment)
Primary	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)
Primary	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	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	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	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	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	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	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	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	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	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	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	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	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)