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

Study Overview
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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.

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.

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

Conditions
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Pediatric Obesity, Early Childhood Caries

Intervention / Treatment
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* Behavioral: Enhanced Usual Care (EUC)
* Behavioral: Intervention


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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). | Behavioral: Intervention<br>* 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.<br>|
| Placebo Comparator: Enhanced Usual Care (EUC)<br>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. | Behavioral: Enhanced Usual Care (EUC)<br>* Per Arm/Group Description, CHWs will provide a pamphlet and dental referral list to participants both groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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]) | 
| Fruits & Vegetables (Common Risk/Behavioral) | Frequency of servings/day obtained by RA assessment using MySmileBuddy | 18 months of age (final follow-up [T2]) | 
| Juice & Sweet Drinks (Common Risk/Behavioral) | Frequency of servings/day obtained by RA assessment using MySmileBuddy | 18 months of age (final follow-up [T2]) | 
| 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]) | 
| Sweet & Salty Snacks (Common Risk/Behavioral) | Frequency of servings obtained by RA assessment using MySmileBuddy | 18 months of age (final follow-up [T2]) | 
| Physical Activity (Obesity/Behavioral) | Time child spent in active play, assessed by parent completed questionnaire | 18 months of age (final follow-up [T2]) | 
| 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]) | 
| Tooth Brushing (Caries/Behavioral) | Frequency of parent wiping/brushing teeth, assessed by parent completed questionnaire | 18 months of age (final follow-up [T2]) | 
| Dental Visits (Caries/Behavioral) | Number of dental visits (child), assessed by parent completed questionnaire | 18 months of age (final follow-up [T2]) | 
| Visible Caries | Any visible caries by intra-oral camera (yes/No) | 18 months of age (T2). | 
| Caries Severity | dfs index | 18 months of age (T2) | 
| 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) | 
| Change in Weight Velocity Z Scores | Weight velocity Z scores: for each 6 month period: 6 m.>12 m. 12 m.>18m | see above |