Clinical trial NCT03077425: Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach
Official title: Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Early Childhood Caries
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Rutgers University
name: University of Rochester
First posted: 2017-03-13
Enrollment: 380
Sex: ALL
Minimum age (years): 3
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled clinical trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Quantity of (Combined) Sippy Cup and/or Bottles (Common Risk/Behavioral)
timeFrame: 18 months of age (final follow-up [T2])
Secondary outcomes:
measure: Added Sweeteners/Solids (Common Risk/Behavioral)
timeFrame: 18 months of age (final follow-up [T2])
measure: Fruits & Vegetables (Common Risk/Behavioral)
timeFrame: 18 months of age (final follow-up [T2])
measure: Juice & Sweet Drinks (Common Risk/Behavioral)
timeFrame: 18 months of age (final follow-up [T2])
measure: Use of Bottles/Sippy Cups at Nap or Bedtime (Common Risk/Behavioral)
timeFrame: 18 months of age (final follow-up [T2])
measure: Sweet & Salty Snacks (Common Risk/Behavioral)
timeFrame: 18 months of age (final follow-up [T2])
measure: Physical Activity (Obesity/Behavioral)
timeFrame: 18 months of age (final follow-up [T2])
measure: Screen Time (Obesity/Behavioral)
timeFrame: 18 months of age (final follow-up [T2])
measure: Tooth Brushing (Caries/Behavioral)
timeFrame: 18 months of age (final follow-up [T2])
measure: Dental Visits (Caries/Behavioral)
timeFrame: 18 months of age (final follow-up [T2])
measure: Visible Caries
timeFrame: 18 months of age (T2).
measure: Caries Severity
timeFrame: 18 months of age (T2)
measure: Weight-for-length
timeFrame: 18 months of age (T2)
measure: Change in Weight Velocity Z Scores
timeFrame: see above
Other outcomes:
Locations:
city: East Windsor
country: United States
facility: Healthy Kids Pediatric Group
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Bronx
country: United States
facility: Morris Heights Health Center
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Group
state: New York
city: Bronx
country: United States
facility: North Central Bronx Hospital
state: New York
city: Jamaica
country: United States
facility: Smart Medical Care
state: New York
city: Queens
country: United States
facility: Dr. Masub's Medical and Dental Office
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Alison Karasz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karasz A, Bonuck K. Reducing pediatric caries and obesity risk in South Asian immigrants: randomized controlled trial of common health/risk factor approach. BMC Public Health. 2018 May 31;18(1):680. doi: 10.1186/s12889-018-5317-9.