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.
Brief Title
Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach
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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Pediatric Obesity
Early Childhood Caries
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).
* 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).
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
2 Years
Minimum Age
3 Months
NCT Id
NCT03077425
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2016-6156
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach
Primary Outcomes
Outcome Description
Number and amount of sippy cups + bottles/day consumed by child, obtained by RA assessment using MySmileBuddy
Outcome Measure
Quantity of (Combined) Sippy Cup and/or Bottles (Common Risk/Behavioral)
Outcome Time Frame
18 months of age (final follow-up [T2])
Secondary Outcomes
Outcome Description
Number of sweeteners and/or solids/day added to child's sippy sups/bottles, obtained by RA
Outcome Time Frame
18 months of age (final follow-up [T2])
Outcome Measure
Added Sweeteners/Solids (Common Risk/Behavioral)
Outcome Description
Frequency of servings/day obtained by RA assessment using MySmileBuddy
Outcome Time Frame
18 months of age (final follow-up [T2])
Outcome Measure
Fruits & Vegetables (Common Risk/Behavioral)
Outcome Description
Frequency of servings/day obtained by RA assessment using MySmileBuddy
Outcome Time Frame
18 months of age (final follow-up [T2])
Outcome Measure
Juice & Sweet Drinks (Common Risk/Behavioral)
Outcome Description
Frequency of child drinking from a bottle or sippy cup/day when put down to bed or nap by RA assessment using MySmileBuddy
Outcome Time Frame
18 months of age (final follow-up [T2])
Outcome Measure
Use of Bottles/Sippy Cups at Nap or Bedtime (Common Risk/Behavioral)
Outcome Description
Frequency of servings obtained by RA assessment using MySmileBuddy
Outcome Time Frame
18 months of age (final follow-up [T2])
Outcome Measure
Sweet & Salty Snacks (Common Risk/Behavioral)
Outcome Description
Time child spent in active play, assessed by parent completed questionnaire
Outcome Time Frame
18 months of age (final follow-up [T2])
Outcome Measure
Physical Activity (Obesity/Behavioral)
Outcome Description
Time child spent in front of TV, computer, iPaD, or phone, assessed by parent completed questionnaire
Outcome Time Frame
18 months of age (final follow-up [T2])
Outcome Measure
Screen Time (Obesity/Behavioral)
Outcome Description
Frequency of parent wiping/brushing teeth, assessed by parent completed questionnaire
Outcome Time Frame
18 months of age (final follow-up [T2])
Outcome Measure
Tooth Brushing (Caries/Behavioral)
Outcome Description
Number of dental visits (child), assessed by parent completed questionnaire
Outcome Time Frame
18 months of age (final follow-up [T2])
Outcome Measure
Dental Visits (Caries/Behavioral)
Outcome Description
Any visible caries by intra-oral camera (yes/No)
Outcome Time Frame
18 months of age (T2).
Outcome Measure
Visible Caries
Outcome Description
dfs index
Outcome Time Frame
18 months of age (T2)
Outcome Measure
Caries Severity
Outcome Description
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
Outcome Time Frame
18 months of age (T2)
Outcome Measure
Weight-for-length
Outcome Description
Weight velocity Z scores: for each 6 month period: 6 m.\>12 m. 12 m.\>18m
Outcome Time Frame
see above
Outcome Measure
Change in Weight Velocity Z Scores
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
2
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Alison Karasz
Investigator Email
alison.karasz@einsteinmed.org
Investigator Phone