What is the mechanism of action of this treatment?

Behavioral interventions, such as those studied in the HALO trial, focus on parent-led health and lifestyle behavior changes. These interventions work by promoting healthier eating habits, increasing physical activity, and reducing sedentary behaviors through structured guidance and support from parents. The mechanisms of action include setting realistic goals, monitoring progress, and providing positive reinforcement. This approach is crucial for childhood obesity patients as it helps establish long-term healthy behaviors, improves weight management, and reduces the risk of obesity-related health issues.

What side effects are associated with this type of intervention?

Behavioral interventions for childhood obesity, such as those studied in the HALO trial, typically focus on promoting healthy eating and increasing physical activity through parent-led initiatives. These interventions generally have minimal side effects, as they emphasize lifestyle changes rather than pharmacological treatments. However, potential challenges may include initial resistance from children, difficulty in maintaining long-term adherence to new routines, and possible psychological stress related to changes in diet and activity levels. Overall, these interventions are considered safe and beneficial for managing childhood obesity.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for drugs treating childhood obesity. However, the HALO trial focuses on a parent-led behavioral intervention targeting health and lifestyle changes in children. This approach aligns with non-pharmacological strategies that emphasize diet and lifestyle modifications, which are commonly recommended for managing childhood obesity.

What other types of research exist?

Promising alternatives to the HALO intervention for childhood obesity include the 'Dynamo Kids/¡Niños Dinámicos!' program, which is a self-guided web-based intervention offered by pediatric primary care providers to help parents implement healthy behaviors in children aged 6-12 years. Another option is the multi-level intervention tested in the pediatric primary care setting, which includes dietary improvements and strategies to reduce sedentary behavior. Both interventions have shown feasibility and preliminary success in promoting healthy lifestyle changes in children.

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Behavioral Intervention for Childhood Obesity (HALO-2 Trial)

N/A

Waitlist Available

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

Must not have

Child BMI is > 120% of the 95th percentile

Female caregiver is not pregnant at time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial tests HALO, a program where parents help their children aged 6-12 adopt healthier habits. It targets kids whose mothers are losing weight after weight-loss surgery, leveraging the parents' motivation to change.

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.

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.

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.

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.

Select...

My caregiver can read, write, and speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My child's BMI is significantly above the average for their age.

Select...

I am a female caregiver and I am not pregnant.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral interventions, such as those studied in the HALO trial, focus on parent-led health and lifestyle behavior changes. These interventions work by promoting healthier eating habits, increasing physical activity, and reducing sedentary behaviors through structured guidance and support from parents. The mechanisms of action include setting realistic goals, monitoring progress, and providing positive reinforcement. This approach is crucial for childhood obesity patients as it helps establish long-term healthy behaviors, improves weight management, and reduces the risk of obesity-related health issues.