Behavioral Intervention for Childhood Obesity

(HALO-2 Trial)

Overseen By Margaret H Zeller, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Pregnancy, Distance, Child BMI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a parent-led program to help children aged 6-12 manage their weight more effectively. The goal is to determine if a combination of online learning, digital tools, and telehealth visits can support children whose mothers have recently undergone weight loss surgery. The trial compares this program to a group receiving Enhanced Standard of Care (also known as Standard Care, Best Practice, or Standard Therapy) advice on healthy habits. Mothers with children who have a BMI (body mass index, a measure of body fat) over the 70th percentile, are not currently in a weight management program, and do not have chronic conditions may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative support methods for children's weight management.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications. It seems focused on behavioral changes rather than medication use.

What prior data suggests that this behavioral intervention is safe for children?

Research has shown that the HALO program, a parent-led approach, helps children develop healthier habits. It is specifically designed for families where mothers are losing weight after bariatric surgery. Although specific safety data for the HALO program is unavailable, similar treatments for childhood obesity have demonstrated positive results, such as slowing weight gain and reducing long-term health risks like type 2 diabetes.

The HALO program incorporates online learning, digital tools, and telehealth visits. These methods are generally manageable because they focus on changing behaviors rather than using medications.

In summary, while direct safety data for HALO is lacking, the program is likely safe since it emphasizes lifestyle changes instead of medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HALO intervention for childhood obesity because it offers a personalized approach that integrates post-bariatric surgery guidelines into lifestyle recommendations, which is not typically done in standard obesity treatments. This program stands out by using a mix of online learning, digital tools, and telehealth visits, tailoring the intervention to support mothers in making family-wide changes. Additionally, HALO addresses unique barriers faced by families post-bariatric surgery, offering customized support that could lead to more effective and sustainable outcomes compared to traditional methods like educational handouts.

What evidence suggests that the HALO intervention is effective for reducing childhood obesity?

Research has shown that programs like HALO, one of the treatments studied in this trial, can help reduce childhood obesity. Studies have found that parental involvement in lifestyle changes, especially for high-risk children, leads to healthier habits. HALO targets children whose mothers are losing weight after weight-loss surgery, fostering a supportive environment for change. The program employs online learning, digital tools, and telehealth to teach parents how to encourage healthy eating and physical activity in their children. These methods have been linked to better health and a lower risk of obesity in children. Meanwhile, the Enhanced Standard of Care, another treatment arm in this trial, provides families with monthly mailings of publicly available, age-appropriate handouts on healthy eating, physical activity, screen time, and healthy sleep habits. ^{1 2 6 7 8}

Who Is on the Research Team?

Margaret H Zeller, PhD

Principal Investigator

Cincinnati Chidren's Hospital Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Child is willing to participate

Child resides in her home > 75% of the time

Child has no chronic medical conditions or developmental disabilities

Exclusion Criteria

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

Must not live >75 miles from Cincinnati Children's Hospital Main Campus

I am a female caregiver and I am not pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

HALO intervention involving online learning, digital technologies, and telehealth visits tailored to integrate post-bariatric surgery guidelines for reducing child obesity risk

26 weeks

Telehealth visits and online sessions

Follow-up

Participants are monitored for changes in physical activity, dietary intake, and other health behaviors

26 weeks

Long-term Follow-up

Continued monitoring of health outcomes such as BMI and physical activity

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Standard of Care
• HALO

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 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 Care Active Control 1 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

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

University of Delaware

Collaborator

Trials

167

Recruited

25,700+

Citations

1. cheoresearch.ca cheoresearch.ca/research/areas/halo/

Healthy Active Living and Obesity (HALO) The focus of the HALO group's research is to: Promote and assess healthy active living among children and youth. Identify, examine and address environmental ...

2. withpower.com withpower.com/trial/phase-pediatric-obesity-2-2022-92e95

Behavioral Intervention for Childhood Obesity (HALO-2 Trial) 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 ...

3. haloresearch.ca haloresearch.ca/publications/

Publications Number of peer-reviewed, refereed publications by HALO Research Group from 2006 to 2019 – for a total of 866 to date.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11992610/

Interventions for Childhood Central Obesity: A Systematic ... This systematic review and meta-analysis investigates the association of lifestyle, behavioral, and pharmacological interventions with childhood central ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2211335525000920

The effectiveness of school-based obesity prevention ... The aim of this study is to synthesise the effects of child obesity prevention programs on diet, physical activity, tobacco smoking and alcohol intake.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10462385/

NET-Works Pediatric Obesity Prevention Trial: 66 Month ... The intervention appeared to be effective in slowing BMI gain 66 months after randomization among children who were already overweight at ages 2–4 years.

7. nature.com nature.com/articles/s41366-022-01198-w

Core outcome set for early intervention trials to prevent ... The finalised COS-EPOCH includes 22 outcomes that should be measured and reported in trials of early childhood obesity prevention interventions ...

8. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2829443

Effect of Pediatric Obesity Treatment on Long-Term Health This cohort study demonstrated that good response to pediatric obesity treatment was associated with reduced long-term morbidity, such as type 2 diabetes, ...