NCT03077425.

Trial name or title	Obesity and caries in young South Asian children: a common risk factor approach (CHALO)
Methods	RCT: NCT03077425
Participants	Recruitment target: 377 participants Inclusion criteria: child < 6 months of age at time of recruitment; child is enrolled in either Medicaid or CHIP; mother was born in India, Pakistan or Bangladesh; mother speaks standard Bengali, English or Hindi/Urdu; mother is index child's primary caretaker Exclusion criteria: inability to provide informed consent; plans to travel for > 1 month during follow‐up; child health condition barring participation (per paediatrician review of recruitment lists) Setting: participants recruited from New York City (n = 3) and New Jersy (n = 2) paediatric practices, USA
Interventions	Intervention group: community health worker‐led intervention comprised of: a) home visits with mothers/families (6 visits over 1 year) and follow‐up telephone support; b) patient navigation to make/keep timely dental visits (2 visits by 18 months). Intervention includes provision of pamphlet with information relating to oral health and dental referral list. Control group: enhanced usual care consisting of community healthcare workers providing mothers with a pamphlet and dental referral list (same as provided to intervention group mothers)
Outcomes	Primary outcome: number and amount of sippy cup and/or bottles consumed/day by child, assessed at 18 months of age Other outcomes: number of sweeteners and/or solids/day added to child's sippy sups/bottles, assessed at 18 months of age; fruit & vegetable servings/day for child, assessed at 18 months of age; juice & sweet drinks servings/day for child, assessed at 18 months of age; frequency of child drinking from a bottle or sippy cup/day when put to bed or nap, assessed using MySmileBuddy at 18 months of age; frequency of sweet & salty snacks consumed by child, assessed 18 months of age; time spent in active play by child, assessed at 18 months of age; child screen time (various measures, including time spent in front of TV) assessed at 18 months of age; frequency of parent wiping/brushing teeth, assessed at 18 months of age; number of dental visits, assessed at 18 months of age; visible child caries, assessed by intra‐oral camera at 18 months of age; caries severity, assessed by dfs index at 18 months of age; weight for length measures, assessed at 18 months of age; change in Weight Velocity Z Scores, 6 months to 12 months, and 12 months to 18 months
Starting date	December 2017
Contact information	Karen Bonuck, email: karen.bonuck@einstein.yu.edu
Notes	Principal Investigator: Alison Karasz, Albert Einstein College of Medicine, Inc.

^{BMI: Body mass index; CHALO: Child Health Action to Lower Oral Health and Obesity; CHIP: Children's Health Insurance Program; dfs: decayed and filled surface (primary); dmfs:decayed missing and filled surfaces (primary); dmft: decayed missing and filled teeth (primary); IHS: Indigenous Health Service; MaXED: Maternal Consumption of Xylitol to Reduce Early Childhood Decay}