Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03077425
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
Columbia University
Rutgers University
University of Rochester
Information provided by (Responsible Party):
Alison Karasz, Albert Einstein College of Medicine

Brief Summary:
The CHALO ("Child Health Action to Lower Oral Health 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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Early Childhood Caries Behavioral: Enhanced Usual Care (EUC) Behavioral: Intervention Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 377 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled clinical trial
Masking: Single (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.

Primary Purpose: Prevention
Official Title: Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach
Actual Study Start Date : December 7, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Intervention
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
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.

Placebo Comparator: Enhanced Usual Care (EUC)

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077425


Contacts
Layout table for location contacts
Contact: Afrida Khurshid, BA 7184303461 afrida.khurshid@einstein.yu.edu
Contact: Karen Bonuck 7184304085 karen.bonuck@einstein.yu.edu

Locations
Layout table for location information
United States, New Jersey
Healthy Kids Pediatric Group Recruiting
East Windsor, New Jersey, United States, 08520
Contact: Utpal Shah, MD    609-448-7300    WeCare@healthykidspeds.com   
Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Usha Ramachandran, MD    732-235-6712    ramachus@rwjms.rutgers.edu   
United States, New York
Jacobi Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Kirsten Roberts, MD    718-918-4084    Kirsten.Roberts@nychhc.org   
Montefiore Medical Group Recruiting
Bronx, New York, United States, 10462
Contact: Colin D Rehm, PhD, MPH       crehm@montefiore.org   
Smart Medical Care Recruiting
Jamaica, New York, United States, 11417
Contact: Maksud Chowdhury, MD    718-526-6660      
Dr. Masub's Medical and Dental Office Recruiting
Queens, New York, United States, 11106
Contact: Hosneara Masub, MD    718-482-0209      
Sponsors and Collaborators
Albert Einstein College of Medicine
Columbia University
Rutgers University
University of Rochester
Investigators
Layout table for investigator information
Principal Investigator: Alison Karasz Albert Einstein College of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Alison Karasz, Prof, Family and Social Medicine, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03077425     History of Changes
Other Study ID Numbers: 2016-6156
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms