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Intervention for Childhood Obesity (CHALO Trial)

N/A
Waitlist Available
Led By Alison Karasz
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months of age (t2)
Awards & highlights

CHALO Trial Summary

This trial is designed to reduce obesity and dental caries risk in South Asian children by implementing a multi-level strategy. The strategy includes a randomized controlled trial to reduce risk behavior and a Knowledge Translation project to raise awareness in South Asian lay and professional communities about child health risks.

Eligible Conditions
  • Childhood Obesity
  • Early Childhood Caries

CHALO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months of age (t2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months of age (t2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quantity of (Combined) Sippy Cup and/or Bottles (Common Risk/Behavioral)
Secondary outcome measures
Added Sweeteners/Solids (Common Risk/Behavioral)
Caries Severity
Change in Weight Velocity Z Scores
+10 more

CHALO Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
An RCT will enroll 360 mothers (total) of children 4-6 month olds from New York City (n=3) and New Jersey (n=2) pediatric practices. Half (180) will be assigned to the Community Health Worker intervention comprised of: a) home visits with mothers/families (n=6 visits over one year) and follow up telephone support; b) patient navigation to make/keep timely dental visits (2x by 18 months).
Group II: Enhanced Usual Care (EUC)Placebo Group1 Intervention
Community Health Workers (CHWs)- will deliver the EUC to all study participants at their 6 month well-child visit, which will occur just after their T0 Baseline Interview, just prior to randomization. EUC Components: 1) Pamphlet- CHWs will hand out and review deliver and review a pamphlet with basic ECC and Obesity prevention messages for parents of 6-18 month olds; and 2) Dental Referral List of dentists who will see 12 month olds, and who accept most insurance plans in the pediatric practices we are recruiting from. Thus, the EUC will be delivered to n=180 families in the EUC Control and n=180 families in the Intervention group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intervention
2011
Completed Phase 4
~73780

Find a Location

Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor
286 Previous Clinical Trials
11,856,185 Total Patients Enrolled
Columbia UniversityOTHER
1,428 Previous Clinical Trials
2,459,740 Total Patients Enrolled
Rutgers UniversityOTHER
113 Previous Clinical Trials
2,803,719 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach
2017. "Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03077425.
~52 spots leftby Apr 2025
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