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Behavioral Intervention for Childhood Obesity (HALO-2 Trial)

N/A

Recruiting

Led By Margaret H Zeller, PhD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child not currently engaged in weight management (behavioral, pharmacologic)

Caregiver is able to read, write, and speak in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 26 weeks (post-treatment) and 52 weeks (6-month follow-up)

Awards & highlights

HALO-2 Trial Summary

This trial is testing a parent-led behavioral intervention targeting a high-risk pediatric population to see if it is feasible and effective.

Who is the study for?

This trial is for children aged 6-12 with a BMI between the 70th and less than 120% of the 95th percentile, whose mothers had bariatric surgery within the last year. The child must live with their mother more than 75% of the time, not be in weight management programs, and have no chronic conditions or developmental disabilities.Check my eligibility

What is being tested?

The HALO program is being tested against an enhanced standard of care to see if it helps kids at risk for obesity due to having a mother who recently underwent bariatric surgery. It's designed as a parent-led intervention during a time when mothers are also changing their health behaviors.See study design

What are the potential side effects?

Since this study focuses on lifestyle interventions rather than medication, traditional side effects are not expected. However, changes in diet and activity levels may cause temporary discomfort or adjustment issues in participants.

HALO-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is not currently in any weight management program.

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My caregiver can read, write, and speak English.

HALO-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 26 weeks (post-treatment) and 52 weeks (6-month follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 26 weeks (post-treatment) and 52 weeks (6-month follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 26 weeks (post-treatment) and 52 weeks (6-month follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Preliminary Efficacy - Change in child body mass index standardized for age/sex from 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)

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

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 26 weeks (post-treatment)

+9 more

Other outcome measures

Attendance/Participation rates

Change in child emotional functioning from baseline to 26 weeks (post-treatment) using Sizing Me Up

Change in child emotional functioning from baseline to 52 weeks (6-month follow-up) using Sizing Me Up

+9 more

HALO-2 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment1 Intervention

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.

Group II: Enhanced Standard of CareActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HALO

2016

N/A

~60

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,546 Total Patients Enrolled

University of DelawareOTHER

154 Previous Clinical Trials

25,161 Total Patients Enrolled

Margaret H Zeller, PhDPrincipal InvestigatorCincinnati Chidren's Hospital Medical Center

Media Library

Enhanced Standard of Care Clinical Trial Eligibility Overview. Trial Name: NCT05350267 — N/A

Childhood Obesity Research Study Groups: Treatment, Enhanced Standard of Care

Childhood Obesity Clinical Trial 2023: Enhanced Standard of Care Highlights & Side Effects. Trial Name: NCT05350267 — N/A

Enhanced Standard of Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05350267 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are accepted into this research project?

"Affirmative. The information on clinicaltrials.gov confirms that this medical trial, which was initially made available for enrollment on 14 March 2022, is actively searching for patients to participate. 50 individuals are needed at one location in order to complete the study."

Answered by AI

What are the main aims of this experiment?

"The main metric for measuring the efficacy of this trial is a shift in child body mass index from baseline to 6 months after treatment. Secondary objectives are tracking changes in caloric and nutrient intake, as well as moderate to vigorous physical activity over the course of 26 weeks via mother-reported 3-day dietary recalls and waist-worn actigraph accelerometers respectively."

Answered by AI

Are new participants being sought for this clinical experiment?

"According to the details on clinicaltrials.gov, this trial is currently looking for volunteers and has been live since March 14th of 2022. It was most recently updated June 16th of that same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery

2022. "Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05350267.