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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-07

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pediatric Obesity Early Childhood Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Research Assessment- at 6, 12, and 18 months will be conducted by RAs. Data collected include a computerized 24 hour recall: MySmileBuddy (see below); and questionnaires. The T2 interview, in addition, will include the Intra-oral Camera Caries Assessment. Study identifiers will not include indication of group assignment. The REDCap database will include group assignment in a field that is not accessible to RAs

Caries Outcomes- Intra-oral camera images will be transmitted electronically to the University of Rochester; no group assignment identifier will be included.

Obesity Outcomes- RAs will obtained weight and length measures in the home- see above.

Study Groups

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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 Type EXPERIMENTAL

Intervention

Intervention Type BEHAVIORAL

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.

Enhanced Usual Care (EUC)

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.

Group Type PLACEBO_COMPARATOR

Enhanced Usual Care (EUC)

Intervention Type BEHAVIORAL

Per Arm/Group Description, CHWs will provide a pamphlet and dental referral list to participants both groups.

Interventions

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Enhanced Usual Care (EUC)

Per Arm/Group Description, CHWs will provide a pamphlet and dental referral list to participants both groups.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

3 Months

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes