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

Albert Einstein College of Medicine

Status: Completed

Conditions: Early Childhood Caries; Pediatric Obesity

Treatments: Behavioral: Intervention; Behavioral: Enhanced Usual Care (EUC)

Study type: Interventional

Funder types: Other

Identifiers

NCT03077425

2016-6156

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 patients

Sex: All

Ages: 3 months to 2 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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380 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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).

Treatment:

Behavioral: Intervention

Enhanced Usual Care (EUC)

Placebo Comparator group

Description:

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:

Behavioral: Enhanced Usual Care (EUC)