Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Early Childhood Caries
- Pediatric Obesity
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: randomized controlled clinical trialMasking: 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.Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 32 years
- Gender
- Both males and females
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 beh...
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.
Tracking Information
- NCT #
- NCT03077425
- Collaborators
- Columbia University
- Rutgers University
- University of Rochester
- Investigators
- Principal Investigator: Alison Karasz Albert Einstein College of Medicine
Get Well Soon