Obesity, ChildhoodHALO-2NCT05350267
Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery
A study testing HALO in people with Obesity, Childhood, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 6 years and older, women only
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- HALO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to 19 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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.
- Conditions
- Obesity, Childhood
- Being tested
- HALO, Enhanced Standard of Care
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HALOBehavioural
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 CareBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Behavioral: HALO |
| Enhanced Standard of Care | Active comparator | 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 Receives: Behavioral: Enhanced Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline to 52 weeks (6-month follow-up post-treatment)
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline to 52 weeks (6-month follow-up post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start14 Mar 2022
- Primary completion10 Mar 2025
- Study completion19 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment versus enhanced standard of care
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware
- Responsible party
- Sponsor
- Investigators
- Margaret H Zeller, PhD, Principal investigator, Cincinnati Chidren's Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350267
- Sponsor's protocol ID
- 2021-0601
- Acronym
- HALO-2
- Status last verified
- Nov 2025
- First submitted
- 22 Apr 2022
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05350267
- Acronym / sponsor ID
- HALO-2 / 2021-0601
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- University of Delaware
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment versus enhanced standard of care
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: HALOHALO 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. |
| Enhanced Standard of Care | Active comparator | Behavioral: Enhanced Standard of CareThe comparator group will receive monthly mailings of publicly available and age-appropriate handouts on healthy eating, physical activity, screen time, and healthy sleep habits |
Who may qualify
- Ages
- 6 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HALOHealth 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. | Behavioural | Treatment |
| Enhanced Standard of CareThe comparator group will receive monthly mailings of publicly available and age-appropriate handouts on healthy eating, physical activity, screen time, and healthy sleep habits | Behavioural | Enhanced Standard of Care |
Primary outcome
Preliminary Efficacy - Change in child body mass index standardized for age/sex from baseline to 26 weeks (post-treatment)
Time frame: 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)
Time frame: 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
12 secondary outcomes
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Time frame: baseline to 52 weeks (6-month follow-up post-treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Obesity, Childhood
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret H Zeller, PhD principal investigator
Cincinnati Chidren's Hospital Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HALO in people with Obesity, Childhood, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary Efficacy - Change in child body mass index standardized for age/sex from baseline to 26 weeks (post-treatment) (time frame: baseline to 26 weeks (post-treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.