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

NCT03077425 | Completed

• 1 other identifier: 2016-6156
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 8

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.

Conditions

Pediatric Obesity; Early Childhood Caries

Outcome Measures

Primary Outcomes (1)

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

  Number and amount of sippy cups + bottles/day consumed by child, obtained by RA assessment using MySmileBuddy

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

Secondary Outcomes (13)

• Added Sweeteners/Solids (Common Risk/Behavioral)

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

• Fruits & Vegetables (Common Risk/Behavioral)

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

• Juice & Sweet Drinks (Common Risk/Behavioral)

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

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

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

• Sweet & Salty Snacks (Common Risk/Behavioral)

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

Study Arms (2)

Intervention

EXPERIMENTAL

An RCT will enroll 360 mothers (total) of children 4-6 month olds from New York City (n=3) and New Jersey (n=2) pediatric practices. Half (180) will be assigned to the Community Health Worker intervention comprised of: 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).

Behavioral: Intervention

Enhanced Usual Care (EUC)

PLACEBO COMPARATOR

Community Health Workers (CHWs)- will deliver the EUC to all study participants at their 6 month well-child visit, which will occur just after their T0 Baseline Interview, just prior to randomization. EUC Components: 1) Pamphlet- CHWs will hand out and review deliver and review a pamphlet with basic ECC and Obesity prevention messages for parents of 6-18 month olds; and 2) Dental Referral List of dentists who will see 12 month olds, and who accept most insurance plans in the pediatric practices we are recruiting from. Thus, the EUC will be delivered to n=180 families in the EUC Control and n=180 families in the Intervention group.

Behavioral: Enhanced Usual Care (EUC)

Interventions

Enhanced Usual Care (EUC) BEHAVIORAL

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

Enhanced Usual Care (EUC)

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.

Intervention

Eligibility Criteria

• Age: 3 Months - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Columbia University: collaborator
• Rutgers University: collaborator
• University of Rochester: collaborator

Study Sites (8)

Healthy Kids Pediatric Group

East Windsor, New Jersey, 08520, United States

Location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Smart Medical Care

Jamaica, New York, 11417, United States

Location

Dr. Masub's Medical and Dental Office

Queens, New York, 11106, United States

Location

Morris Heights Health Center

The Bronx, New York, 10453, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Montefiore Medical Group

The Bronx, New York, 10462, United States

Location

North Central Bronx Hospital

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Karasz A, Bonuck K. Reducing pediatric caries and obesity risk in South Asian immigrants: randomized controlled trial of common health/risk factor approach. BMC Public Health. 2018 May 31;18(1):680. doi: 10.1186/s12889-018-5317-9.

  PMID: 29855352 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Methods

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Alison Karasz

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled clinical trial

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 13, 2017
• Study Start: December 7, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)