Back to resultsChanging Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery (HALO-2)
Primary Purpose
Obesity, Childhood
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HALO
Enhanced Standard of Care
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Childhood
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
Sites / Locations
- Cincinnati Children's Hospital Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment
Enhanced Standard of Care
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
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.
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
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
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.
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.
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).
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).
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.
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.
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.
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.
Full Information
NCT ID
NCT05350267
First Posted
April 22, 2022
Last Updated
July 7, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
University of Delaware
1. Study Identification
Unique Protocol Identification Number
NCT05350267
Brief Title
Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery
Acronym
HALO-2
Official Title
Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
University of Delaware
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Treatment versus enhanced standard of care
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Standard of Care
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
HALO
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Standard of Care
Intervention Description
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
Primary Outcome Measure Information:
Title
Preliminary Efficacy - Change in child body mass index standardized for age/sex from baseline to 26 weeks (post-treatment)
Description
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)
Title
Preliminary Efficacy - Change in child body mass index standardized for age/sex from baseline to 52 weeks (6-month follow-up)
Description
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 Outcome Measure Information:
Title
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
Description
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)
Title
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
Description
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)
Title
Secondary - Change in child minutes of moderate to vigorous physical activity (MVPA) from baseline to 26 weeks (post-treatment)
Description
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)
Title
Secondary - Change in child minutes of moderate to vigorous physical activity (MVPA) from baseline to 52 weeks (6-month follow-up)
Description
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)
Title
Secondary - Change in mother-reported child feeding practices of restriction, pressure to eat, perceived responsibility, and monitoring from baseline to 26 weeks (post-treatment)
Description
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)
Title
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)
Description
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)
Title
Secondary - Change in child hours of screen time from baseline to 26 weeks (post-treatment)
Description
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)
Title
Secondary - Change in child hours of screen time from baseline to 52 weeks (6-month follow-up)
Description
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)
Title
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)
Description
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)
Title
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)
Description
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)
Title
Secondary - Change in mother use of encouragement/modeling from baseline to 26 weeks (post-treatment)
Description
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)
Title
Secondary - Change in mother use of encouragement/modeling from baseline to 52 weeks (6-month follow-up)
Description
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)
Other Pre-specified Outcome Measures:
Title
Change in maternal percent weight loss and body mass index from baseline to 26 weeks (post-treatment)
Description
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).
Time Frame
baseline to 26 weeks (post-treatment)
Title
Change in maternal percent weight loss and body mass index from baseline to 52 weeks (6-month follow-up)
Description
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).
Time Frame
baseline to 52 weeks (6-month follow-up post-treatment)
Title
Change in maternal total kcals from baseline to 26 weeks (post-treatment) using a 3-day dietary recall
Description
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.
Time Frame
baseline to 26 weeks (post-treatment)
Title
Change in maternal total kcals from baseline to 52 weeks (6-month follow-up) using a 3-day dietary recall
Description
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.
Time Frame
baseline to 52 weeks (6-month follow-up post-treatment)
Title
Change in mother's minutes of moderate to vigorous physical activity from baseline to 26 weeks (post-treatment)
Description
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.
Time Frame
baseline to 26 weeks (post-treatment)
Title
Change in mother's minutes of moderate to vigorous physical activity from baseline to 52 weeks (6-month follow-up)
Description
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.
Time Frame
baseline to 52 weeks (6-month follow-up post-treatment)
Title
Change in child emotional functioning from baseline to 26 weeks (post-treatment) using Sizing Me Up
Description
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.
Time Frame
baseline to 26 weeks (post-treatment)
Title
Change in child emotional functioning from baseline to 52 weeks (6-month follow-up) using Sizing Me Up
Description
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.
Time Frame
baseline to 52 weeks (6-month follow-up post-treatment)
Title
Attendance/Participation rates
Description
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).
Time Frame
baseline to 26 weeks (post-treatment) and 52 weeks (6-month follow-up)
Title
Implementation - Fidelity
Description
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.
Time Frame
baseline to 26 weeks (post-treatment)
Title
Implementation - Usability/Satisfaction
Description
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.
Time Frame
baseline to 26 weeks (post-treatment)
Title
Time needed for intervention
Description
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.
Time Frame
baseline to 26 weeks (post-treatment)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret H Zeller, PhD
Phone
513-636-2712
Email
meg.zeller@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret H Zeller, PhD
Organizational Affiliation
Cincinnati Chidren's Hospital Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meg Zeller, PhD
Phone
513-636-2712
Email
meg.zeller@cchmc.org
First Name & Middle Initial & Last Name & Degree
Meg Zeller, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Prior to sharing, all data will be de-identified in a HIPAA-compliant fashion. Data sets will be carefully reviewed to make sure that information such as age and sex cannot be used to gather additional information that could potentially identify individual subjects. All categorical demographic variables will be collapsed into categories large enough so that combinations of demographic categories for age, sex, geographic location, etc., will have 10 or more individuals in each cell. All modalities of data will be shared, including raw and aggregate data. Descriptors for all variables shared will be included to prevent misuse or confusion. Any analytical methods utilized to assess the data will be defined in shared formats.
IPD Sharing Time Frame
12 months following completion of the study
IPD Sharing Access Criteria
PI will provide information
Learn more about this trial
Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery
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