HALO for Pediatric Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cincinnati Children's Hospital Medical Center, Cincinnati, OH
Pediatric Obesity+1 More
HALO - Behavioral
Eligibility
Any Age
Female
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Pediatric Obesity
  • Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 12 Secondary · Reporting Duration: baseline to 26 weeks (post-treatment) and 52 weeks (6-month follow-up)

Week 26
Change in child emotional functioning from baseline to 26 weeks (post-treatment) using Sizing Me Up
Change in maternal percent weight loss and body mass index from baseline to 26 weeks (post-treatment)
Change in maternal total kcals from baseline to 26 weeks (post-treatment) using a 3-day dietary recall
Change in mother's minutes of moderate to vigorous physical activity from baseline to 26 weeks (post-treatment)
Implementation - Fidelity
Implementation - Usability/Satisfaction
Preliminary Efficacy - Change in child body mass index standardized for age/sex from 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 26 weeks (post-treatment) using a 3-day dietary recall
Secondary - Change in child hours of screen time from baseline to 26 weeks (post-treatment)
Secondary - Change in child minutes of moderate to vigorous physical activity (MVPA) from baseline to 26 weeks (post-treatment)
Secondary - Change in mother use of encouragement/modeling from 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 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 26 weeks (post-treatment)
Time needed for intervention
Week 52
Attendance/Participation rates
Week 52
Change in child emotional functioning from baseline to 52 weeks (6-month follow-up) using Sizing Me Up
Change in maternal percent weight loss and body mass index from baseline to 52 weeks (6-month follow-up)
Change in maternal total kcals from baseline to 52 weeks (6-month follow-up) using a 3-day dietary recall
Change in mother's minutes of moderate to vigorous physical activity from baseline to 52 weeks (6-month follow-up)
Preliminary Efficacy - Change in child body mass index standardized for age/sex from baseline to 52 weeks (6-month follow-up)
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
Secondary - Change in child hours of screen time from baseline to 52 weeks (6-month follow-up)
Secondary - Change in child minutes of moderate to vigorous physical activity (MVPA) from baseline to 52 weeks (6-month follow-up)
Secondary - Change in mother use of encouragement/modeling from baseline to 52 weeks (6-month follow-up)
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)
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)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Enhanced Standard of Care
1 of 2
Treatment
1 of 2
Active Control
Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: HALO · No Placebo Group · N/A

Treatment
Behavioral
Experimental Group · 1 Intervention: HALO · Intervention Types: Behavioral
Enhanced Standard of Care
Behavioral
ActiveComparator Group · 1 Intervention: Enhanced Standard of Care · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HALO
2016
N/A
~60

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 26 weeks (post-treatment) and 52 weeks (6-month follow-up)
Closest Location: Cincinnati Children's Hospital Medical Center · Cincinnati, OH
Photo of Cincinnati 1Photo of Cincinnati 2Photo of Cincinnati 3
2011First Recorded Clinical Trial
6 TrialsResearching Pediatric Obesity
713 CompletedClinical Trials

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
736 Previous Clinical Trials
5,414,787 Total Patients Enrolled
6 Trials studying Pediatric Obesity
15,370 Patients Enrolled for Pediatric Obesity
University of DelawareOTHER
130 Previous Clinical Trials
36,400 Total Patients Enrolled
3 Trials studying Pediatric Obesity
143 Patients Enrolled for Pediatric Obesity
Margaret H Zeller, PhDPrincipal InvestigatorCincinnati Chidren's Hospital Medical Center

Eligibility Criteria

Age Any Age · Female Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The caregiver is aged 3-12 months post undergoing a non-device based bariatric surgical procedure.
You are able to read, write, and speak in English.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.