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HeLP vs Usual Care for Childhood Obesity

N/A
Recruiting
Led By Matthew A Haemer, MD MPH
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
With overweight or obesity (BMI >85th percentile)
Up to two siblings of any BMI status (if multiple siblings are available, enrollment goals stratified by age and BMI will be used to select siblings for enrollment.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 48
Awards & highlights

Study Summary

This trial is comparing a new childhood obesity treatment program called HeLP to a usual care protocol that delivers recommended obesity treatments in primary care. Children with obesity and their families will be referred by primary care providers and randomized to either HeLP or RTOP. The trial will take place in a practice-based research network serving mostly Hispanic and Medicaid-insured populations.

Who is the study for?
This trial is for children aged 2-16 with obesity, referred by their primary care provider. It's designed for Hispanic families and those on Medicaid. The child must be able to walk and talk, not have severe depression or other serious health issues related to obesity. Parents need to speak Spanish or English.Check my eligibility
What is being tested?
The study compares the 'Healthy Living Program' (HeLP), a family-inclusive program held at recreation centers, against enhanced usual care called RTOP in clinics. HeLP includes intensive sessions and follow-ups led by health educators.See study design
What are the potential side effects?
Since this trial involves lifestyle changes like healthy eating and physical activity rather than medication, side effects are minimal but may include initial discomfort adjusting to new habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is above the 85th percentile, indicating overweight or obesity.
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Up to two of my siblings can join the study, regardless of their weight.
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My child is between 2 and 16 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Adoption as measured by the proportion of training sessions attended by medical providers
Change from Baseline in 18 months in levels of Familism as measured by the Pan-Hispanic Familism Scale
Change from Baseline in Adult Caregiver Body Mass Index (BMI) at 12 months
+31 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Community based childhood obesity interventionExperimental Treatment1 Intervention
A novel family-inclusive childhood obesity treatment program consisting of 12 family group sessions delivered in English and Spanish by health educators at community recreation centers, followed by three group booster sessions occurring every 6 months.
Group II: Primary care based childhood obesity interventionActive Control1 Intervention
A healthy lifestyle counseling intervention delivered by trained primary care providers and health educators at visits occurring every 3 months.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,729 Previous Clinical Trials
2,143,034 Total Patients Enrolled
Colorado State UniversityOTHER
123 Previous Clinical Trials
37,346 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,345 Previous Clinical Trials
4,313,738 Total Patients Enrolled

Media Library

Recommended Treatment of Obesity in Primary Care Clinical Trial Eligibility Overview. Trial Name: NCT05041855 — N/A
Childhood Obesity Research Study Groups: Primary care based childhood obesity intervention, Community based childhood obesity intervention
Childhood Obesity Clinical Trial 2023: Recommended Treatment of Obesity in Primary Care Highlights & Side Effects. Trial Name: NCT05041855 — N/A
Recommended Treatment of Obesity in Primary Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05041855 — N/A

Frequently Asked Questions

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

What is the headcount of participants associated with this experiment?

"Indeed, the information posted on clinicaltrials.gov confirms that this trial is seeking participants. Its original posting was November 15th 2021 and it was last updated on May 19th 2022. 658 patients will be allowed to join from two distinct sites."

Answered by AI

Are there still vacancies in this experiment to be filled by volunteers?

"Affirmative. Information found on clinicaltrials.gov reveals that this medical experiment, which was originally posted on November 15th 2021, is still actively seeking recruits. The trial requires 658 individuals to be recruited from two different sites."

Answered by AI
Recent research and studies
~317 spots leftby May 2026