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Completed

NCT Number: NCT03077425

Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach

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.

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Key information

Age range

3 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Healthy Kids Pediatric Group, East Windsor, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

enhanced usual care (EUC)

Behavioral

Per Arm/Group Description, CHWs will provide a pamphlet and dental referral list to participants both groups.

Intervention

Behavioral

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.

Primary outcomes

  1. Quantity of (Combined) Sippy Cup and/or Bottles (Common Risk/Behavioral)

    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

Secondary outcomes

  1. Added Sweeteners/Solids (Common Risk/Behavioral)

    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

  2. Fruits & Vegetables (Common Risk/Behavioral)

    Time frame: 18 months of age (final follow-up [T2])

    Frequency of servings/day obtained by RA assessment using MySmileBuddy

  3. Juice & Sweet Drinks (Common Risk/Behavioral)

    Time frame: 18 months of age (final follow-up [T2])

    Frequency of servings/day obtained by RA assessment using MySmileBuddy

  4. Use of Bottles/Sippy Cups at Nap or Bedtime (Common Risk/Behavioral)

    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

  5. Sweet & Salty Snacks (Common Risk/Behavioral)

    Time frame: 18 months of age (final follow-up [T2])

    Frequency of servings obtained by RA assessment using MySmileBuddy

  6. Physical Activity (Obesity/Behavioral)

    Time frame: 18 months of age (final follow-up [T2])

    Time child spent in active play, assessed by parent completed questionnaire

  7. Screen Time (Obesity/Behavioral)

    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

  8. Tooth Brushing (Caries/Behavioral)

    Time frame: 18 months of age (final follow-up [T2])

    Frequency of parent wiping/brushing teeth, assessed by parent completed questionnaire

  9. Dental Visits (Caries/Behavioral)

    Time frame: 18 months of age (final follow-up [T2])

    Number of dental visits (child), assessed by parent completed questionnaire

  10. Visible Caries

    Time frame: 18 months of age (T2).

    Any visible caries by intra-oral camera (yes/No)

  11. Caries Severity

    Time frame: 18 months of age (T2)

    dfs index

  12. Weight-for-length

    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

  13. Change in Weight Velocity Z Scores

    Time frame: see above

    Weight velocity Z scores: for each 6 month period: 6 m.>12 m. 12 m.>18m

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • Columbia University
  • Rutgers University
  • University of Rochester

Registry information

Acronym: CHALO

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 13, 2017
Registry last updated
Jul 27, 2022

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.

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