Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach

Pediatric Obesity Clinical Trial

— CHALO  

Official title:

Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077425
• Other study ID #: 2016-6156
• Status: Completed
• Phase: N/A
• Start date: December 7, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2022
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The CHALO ("Child Health Action to Lower Oral Caries and Obesity") -- from an Urdu word meaning "Let's go!"-is a multi-level strategy to reduce pediatric obesity and dental caries risk in South Asian (SA) children. Obesity and caries are the two most prominent health disparities of early childhood. Both caries and obesity: a) disproportionately impact low-income children of color, b) share common risk behaviors, i.e., feeding practices, and c) can most effectively be reduced or prevented prevention in infancy and early childhood. SA immigrant children are at high risk for both. CHALO includes both a randomized controlled trial (RCT) aimed at reducing risk behavior, and a Knowledge Translation project to raise awareness in SA lay and professional communities regarding child health risks.

Description:

CHALO builds upon the team's prior research re: cariogenic (R34-DE-022282) and obesogenic behaviors (10, 14, 15). CHALO's intervention components-- home visits, phone support, and "patient navigation" to dental visits-- proved to be feasible and acceptable. In the pilot R34, there were promising behavioral change on all measures. CHALO builds on this work, with the addition of: a) sippy cups as an intervention target, b) an iPad-based dietary recall tool, "MySmileBuddy," c) caries and obesity data, and; d) increased intervention contacts- consistent with recent child obesity and caries interventions (16, 17).

An RCT (Aim 1) will enroll 360 mothers of children 4-6 month olds from New York City (n=3) and New Jersey (n=2) pediatric practices in SAPPHIRE ("SA Practice Partnership for Health Improvement and Research"). The Community Health Worker intervention includes: 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). The Knowledge Translation component (Aim 2) will raise awareness of child health risks in SA communities and among professionals who provide their care. The campaign will include both traditional and social media components and will be evaluated using multiple metrics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 2 Years

Eligibility

Inclusion Criteria:

• Age: Child is < 6 months of age at time of recruitment

• Insurance: Child is enrolled in either Medicaid or CHIP

• Nativity- Mother was born in India, Pakistan, or Bangladesh)

• Language- Mother speaks standard Bengali, English or Hindi/Urdu

• Agency- Mother is index child's primary caretaker.

Exclusion Criteria:

• Inability to provide informed consent per RA judgment

• Plans to travel for > 1 month during follow-up, and

• child health condition barring participation (per pediatrician review of recruitment lists).

Related Conditions & MeSH terms

• Early Childhood Caries
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Enhanced Usual Care (EUC)
Per Arm/Group Description, CHWs will provide a pamphlet and dental referral list to participants both groups.
• Intervention
Per Arm/Group Description, CHWs will a) conduct 6 home visits with mothers/families over a 12 month period along with follow-up phone support, and b) patient navigation support for child to receive 2 dental visits: one by 12 months of age and one by 18 months of age.

Locations

Country	Name	City	State
United States	Jacobi Medical Center	Bronx	New York
United States	Montefiore Medical Group	Bronx	New York
United States	Morris Heights Health Center	Bronx	New York
United States	North Central Bronx Hospital	Bronx	New York
United States	Healthy Kids Pediatric Group	East Windsor	New Jersey
United States	Smart Medical Care	Jamaica	New York
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Dr. Masub's Medical and Dental Office	Queens	New York

Sponsors (4)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	Columbia University, Rutgers University, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of (Combined) Sippy Cup and/or Bottles (Common Risk/Behavioral)	Number and amount of sippy cups + bottles/day consumed by child, obtained by RA assessment using MySmileBuddy	18 months of age (final follow-up [T2])
Secondary	Added Sweeteners/Solids (Common Risk/Behavioral)	Number of sweeteners and/or solids/day added to child's sippy sups/bottles, obtained by RA	18 months of age (final follow-up [T2])
Secondary	Fruits & Vegetables (Common Risk/Behavioral)	Frequency of servings/day obtained by RA assessment using MySmileBuddy	18 months of age (final follow-up [T2])
Secondary	Juice & Sweet Drinks (Common Risk/Behavioral)	Frequency of servings/day obtained by RA assessment using MySmileBuddy	18 months of age (final follow-up [T2])
Secondary	Use of Bottles/Sippy Cups at Nap or Bedtime (Common Risk/Behavioral)	Frequency of child drinking from a bottle or sippy cup/day when put down to bed or nap by RA assessment using MySmileBuddy	18 months of age (final follow-up [T2])
Secondary	Sweet & Salty Snacks (Common Risk/Behavioral)	Frequency of servings obtained by RA assessment using MySmileBuddy	18 months of age (final follow-up [T2])
Secondary	Physical Activity (Obesity/Behavioral)	Time child spent in active play, assessed by parent completed questionnaire	18 months of age (final follow-up [T2])
Secondary	Screen Time (Obesity/Behavioral)	Time child spent in front of TV, computer, iPaD, or phone, assessed by parent completed questionnaire	18 months of age (final follow-up [T2])
Secondary	Tooth Brushing (Caries/Behavioral)	Frequency of parent wiping/brushing teeth, assessed by parent completed questionnaire	18 months of age (final follow-up [T2])
Secondary	Dental Visits (Caries/Behavioral)	Number of dental visits (child), assessed by parent completed questionnaire	18 months of age (final follow-up [T2])
Secondary	Visible Caries	Any visible caries by intra-oral camera (yes/No)	18 months of age (T2).
Secondary	Caries Severity	dfs index	18 months of age (T2)
Secondary	Weight-for-length	BMI-for-age Z scores, standardized for sex and actual age at measurement at the baseline (T0), T1 (12 m.) and T2 (18 m.) interviews. We will categorize children as "overweight" and "obese" if their BMI-for-age Z-scores exceed +2 and +3, respectively, as recommended by the WHO	18 months of age (T2)
Secondary	Change in Weight Velocity Z Scores	Weight velocity Z scores: for each 6 month period: 6 m.>12 m. 12 m.>18m	see above