Early Childhood Caries, Pediatric Obesity
Conditions
Brief 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.
Detailed 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.
Interventions
BEHAVIORALEnhanced Usual Care (EUC)
Per Arm/Group Description, CHWs will provide a pamphlet and dental referral list to participants both groups.
BEHAVIORALIntervention
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.
Sponsors
Columbia University
Rutgers University
University of Rochester
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
3 Months to 2 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of (Combined) Sippy Cup and/or Bottles (Common Risk/Behavioral) | 18 months of age (final follow-up [T2]) | Number and amount of sippy cups + bottles/day consumed by child, obtained by RA assessment using MySmileBuddy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fruits & Vegetables (Common Risk/Behavioral) | 18 months of age (final follow-up [T2]) | Frequency of servings/day obtained by RA assessment using MySmileBuddy |
| Juice & Sweet Drinks (Common Risk/Behavioral) | 18 months of age (final follow-up [T2]) | Frequency of servings/day obtained by RA assessment using MySmileBuddy |
| Use of Bottles/Sippy Cups at Nap or Bedtime (Common Risk/Behavioral) | 18 months of age (final follow-up [T2]) | Frequency of child drinking from a bottle or sippy cup/day when put down to bed or nap by RA assessment using MySmileBuddy |
| Sweet & Salty Snacks (Common Risk/Behavioral) | 18 months of age (final follow-up [T2]) | Frequency of servings obtained by RA assessment using MySmileBuddy |
| Physical Activity (Obesity/Behavioral) | 18 months of age (final follow-up [T2]) | Time child spent in active play, assessed by parent completed questionnaire |
| Screen Time (Obesity/Behavioral) | 18 months of age (final follow-up [T2]) | Time child spent in front of TV, computer, iPaD, or phone, assessed by parent completed questionnaire |
| Added Sweeteners/Solids (Common Risk/Behavioral) | 18 months of age (final follow-up [T2]) | Number of sweeteners and/or solids/day added to child's sippy sups/bottles, obtained by RA |
| Dental Visits (Caries/Behavioral) | 18 months of age (final follow-up [T2]) | Number of dental visits (child), assessed by parent completed questionnaire |
| Visible Caries | 18 months of age (T2). | Any visible caries by intra-oral camera (yes/No) |
| Caries Severity | 18 months of age (T2) | dfs index |
| Weight-for-length | 18 months of age (T2) | 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 |
| Change in Weight Velocity Z Scores | see above | Weight velocity Z scores: for each 6 month period: 6 m.\>12 m. 12 m.\>18m |
| Tooth Brushing (Caries/Behavioral) | 18 months of age (final follow-up [T2]) | Frequency of parent wiping/brushing teeth, assessed by parent completed questionnaire |
Countries
United States
Outcome results
None listed