enhanced usual care (EUC)
BehavioralPer Arm/Group Description, CHWs will provide a pamphlet and dental referral list to participants both groups.
NCT Number: NCT03077425
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.
Looking for future studies?
Notify Me3 month–2 year
All sexes
Interventional
Not applicable
Healthy Kids Pediatric Group, East Windsor, New Jersey, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Per Arm/Group Description, CHWs will provide a pamphlet and dental referral list to participants both groups.
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.
Time frame: 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
Time frame: 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
Time frame: 18 months of age (final follow-up [T2])
Frequency of servings/day obtained by RA assessment using MySmileBuddy
Time frame: 18 months of age (final follow-up [T2])
Frequency of servings/day obtained by RA assessment using MySmileBuddy
Time frame: 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
Time frame: 18 months of age (final follow-up [T2])
Frequency of servings obtained by RA assessment using MySmileBuddy
Time frame: 18 months of age (final follow-up [T2])
Time child spent in active play, assessed by parent completed questionnaire
Time frame: 18 months of age (final follow-up [T2])
Time child spent in front of TV, computer, iPaD, or phone, assessed by parent completed questionnaire
Time frame: 18 months of age (final follow-up [T2])
Frequency of parent wiping/brushing teeth, assessed by parent completed questionnaire
Time frame: 18 months of age (final follow-up [T2])
Number of dental visits (child), assessed by parent completed questionnaire
Time frame: 18 months of age (T2).
Any visible caries by intra-oral camera (yes/No)
Time frame: 18 months of age (T2)
dfs index
Time frame: 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
Time frame: see above
Weight velocity Z scores: for each 6 month period: 6 m.>12 m. 12 m.>18m
Albert Einstein College of Medicine
Other
Acronym: CHALO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06085040
Body Weight, Nutrition Disorders
Clermont-Ferrand, France
View Trial DetailsNCT06548074
Behavior, Body Weight
Las Cruces, New Mexico, United States
View Trial DetailsNCT06981429
Body Weight, Nutrition Disorder
Buffalo, New York, United States
View Trial DetailsNCT06357299
Body Weight, Body Weight Changes
Durham, North Carolina, United States
View Trial Details