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

Primary Purpose

Pediatric Obesity, Early Childhood Caries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Usual Care (EUC)
Intervention
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pediatric Obesity

Eligibility Criteria

3 Months - 2 Years (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Healthy Kids Pediatric Group
  • Robert Wood Johnson University Hospital
  • Morris Heights Health Center
  • Jacobi Medical Center
  • Montefiore Medical Group
  • North Central Bronx Hospital
  • Smart Medical Care
  • Dr. Masub's Medical and Dental Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Enhanced Usual Care (EUC)

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Added Sweeteners/Solids (Common Risk/Behavioral)
Number of sweeteners and/or solids/day added to child's sippy sups/bottles, obtained by RA
Fruits & Vegetables (Common Risk/Behavioral)
Frequency of servings/day obtained by RA assessment using MySmileBuddy
Juice & Sweet Drinks (Common Risk/Behavioral)
Frequency of servings/day obtained by RA assessment using MySmileBuddy
Use of Bottles/Sippy Cups at Nap or Bedtime (Common Risk/Behavioral)
Frequency of child drinking from a bottle or sippy cup/day when put down to bed or nap by RA assessment using MySmileBuddy
Sweet & Salty Snacks (Common Risk/Behavioral)
Frequency of servings obtained by RA assessment using MySmileBuddy
Physical Activity (Obesity/Behavioral)
Time child spent in active play, assessed by parent completed questionnaire
Screen Time (Obesity/Behavioral)
Time child spent in front of TV, computer, iPaD, or phone, assessed by parent completed questionnaire
Tooth Brushing (Caries/Behavioral)
Frequency of parent wiping/brushing teeth, assessed by parent completed questionnaire
Dental Visits (Caries/Behavioral)
Number of dental visits (child), assessed by parent completed questionnaire
Visible Caries
Any visible caries by intra-oral camera (yes/No)
Caries Severity
dfs index
Weight-for-length
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
Change in Weight Velocity Z Scores
Weight velocity Z scores: for each 6 month period: 6 m.>12 m. 12 m.>18m

Full Information

First Posted
March 2, 2017
Last Updated
July 26, 2022
Sponsor
Albert Einstein College of Medicine
Collaborators
Columbia University, Rutgers University, University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT03077425
Brief Title
Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach
Acronym
CHALO
Official Title
Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
Columbia University, Rutgers University, University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Early Childhood Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled clinical trial
Masking
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.
Allocation
Randomized
Enrollment
380 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Enhanced Usual Care (EUC)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care (EUC)
Intervention Description
Per Arm/Group Description, CHWs will provide a pamphlet and dental referral list to participants both groups.
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
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 Outcome Measure Information:
Title
Quantity of (Combined) Sippy Cup and/or Bottles (Common Risk/Behavioral)
Description
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])
Secondary Outcome Measure Information:
Title
Added Sweeteners/Solids (Common Risk/Behavioral)
Description
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])
Title
Fruits & Vegetables (Common Risk/Behavioral)
Description
Frequency of servings/day obtained by RA assessment using MySmileBuddy
Time Frame
18 months of age (final follow-up [T2])
Title
Juice & Sweet Drinks (Common Risk/Behavioral)
Description
Frequency of servings/day obtained by RA assessment using MySmileBuddy
Time Frame
18 months of age (final follow-up [T2])
Title
Use of Bottles/Sippy Cups at Nap or Bedtime (Common Risk/Behavioral)
Description
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])
Title
Sweet & Salty Snacks (Common Risk/Behavioral)
Description
Frequency of servings obtained by RA assessment using MySmileBuddy
Time Frame
18 months of age (final follow-up [T2])
Title
Physical Activity (Obesity/Behavioral)
Description
Time child spent in active play, assessed by parent completed questionnaire
Time Frame
18 months of age (final follow-up [T2])
Title
Screen Time (Obesity/Behavioral)
Description
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])
Title
Tooth Brushing (Caries/Behavioral)
Description
Frequency of parent wiping/brushing teeth, assessed by parent completed questionnaire
Time Frame
18 months of age (final follow-up [T2])
Title
Dental Visits (Caries/Behavioral)
Description
Number of dental visits (child), assessed by parent completed questionnaire
Time Frame
18 months of age (final follow-up [T2])
Title
Visible Caries
Description
Any visible caries by intra-oral camera (yes/No)
Time Frame
18 months of age (T2).
Title
Caries Severity
Description
dfs index
Time Frame
18 months of age (T2)
Title
Weight-for-length
Description
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
18 months of age (T2)
Title
Change in Weight Velocity Z Scores
Description
Weight velocity Z scores: for each 6 month period: 6 m.>12 m. 12 m.>18m
Time Frame
see above

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Karasz
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthy Kids Pediatric Group
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Morris Heights Health Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10453
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Group
City
Bronx
State/Province
New York
ZIP/Postal Code
10462
Country
United States
Facility Name
North Central Bronx Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Smart Medical Care
City
Jamaica
State/Province
New York
ZIP/Postal Code
11417
Country
United States
Facility Name
Dr. Masub's Medical and Dental Office
City
Queens
State/Province
New York
ZIP/Postal Code
11106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29855352
Citation
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.
Results Reference
derived

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

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