- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03077425
Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach (CHALO)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
East Windsor, New Jersey, United States, 08520
- Healthy Kids Pediatric Group
-
New Brunswick, New Jersey, United States, 08901
- Robert Wood Johnson University Hospital
-
-
New York
-
Bronx, New York, United States, 10461
- Jacobi Medical Center
-
Bronx, New York, United States, 10453
- Morris Heights Health Center
-
Bronx, New York, United States, 10462
- Montefiore Medical Group
-
Bronx, New York, United States, 10467
- North Central Bronx Hospital
-
Jamaica, New York, United States, 11417
- Smart Medical Care
-
Queens, New York, United States, 11106
- Dr. Masub's Medical and Dental Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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).
|
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. |
Per Arm/Group Description, CHWs will provide a pamphlet and dental referral list to participants both groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
18 months of age (final follow-up [T2])
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
18 months of age (final follow-up [T2])
|
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
|
18 months of age (final follow-up [T2])
|
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
|
18 months of age (final follow-up [T2])
|
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
|
18 months of age (final follow-up [T2])
|
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
|
18 months of age (final follow-up [T2])
|
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
|
18 months of age (final follow-up [T2])
|
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
|
18 months of age (final follow-up [T2])
|
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
|
18 months of age (final follow-up [T2])
|
Dental Visits (Caries/Behavioral)
Time Frame: 18 months of age (final follow-up [T2])
|
Number of dental visits (child), assessed by parent completed questionnaire
|
18 months of age (final follow-up [T2])
|
Visible Caries
Time Frame: 18 months of age (T2).
|
Any visible caries by intra-oral camera (yes/No)
|
18 months of age (T2).
|
Caries Severity
Time Frame: 18 months of age (T2)
|
dfs index
|
18 months of age (T2)
|
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
|
18 months of age (T2)
|
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
|
see above
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alison Karasz, Albert Einstein College of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-6156
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric Obesity
-
Virginia Commonwealth UniversityActive, not recruitingObesity, PediatricUnited States
-
University of British ColumbiaThe Hospital for Sick Children; Canadian Institutes of Health Research (CIHR); Alberta Health services and other collaboratorsCompleted
-
Hasselt UniversityJessa HospitalCompletedObesity, Pediatric
-
Azienda Ospedaliera Universitaria Integrata VeronaNot yet recruitingObesity, Pediatric
-
University of British ColumbiaHeart and Stroke Foundation of Canada; Public Health Agency of Canada (PHAC); Childhood Obesity Foundation and other collaboratorsCompleted
-
Columbia UniversityCompletedVitamin D Deficiency | Obesity, Morbid | Obesity, Childhood | Obesity, PediatricUnited States
-
University Hospital, Clermont-FerrandAME2P Laboratory, Clermont Auvergne UniversityCompleted
-
Medical College of WisconsinWisconsin Department of Health and Family Services; Children's Health System...TerminatedPediatric Obesity | Pediatric OverweightUnited States
-
Kahramanmaras Sutcu Imam UniversityCompletedPediatric Obesity | Pediatric DentistryTurkey
-
Central Hospital, Nancy, FranceNot yet recruiting
Clinical Trials on Intervention
-
Biolux Research Holdings, Inc.TerminatedOrthodontic Tooth MovementCanada
-
University of California, San FranciscoNational Cancer Institute (NCI)CompletedColorectal Carcinoma | Healthy Subject | Health Status UnknownUnited States
-
University of FloridaCompletedSensitivityUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Institute on Minority Health and...RecruitingHuman Papillomavirus InfectionUnited States
-
Ohio State University Comprehensive Cancer CenterCompleted
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnCancer Survivor | Peripheral Sensory Neuropathy
-
Nottingham Trent UniversityUnknownOverweight and ObesityUnited Kingdom
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityRecruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage IIIA Breast Cancer AJCC v8 | Prognostic... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...American Cancer Society, Inc.Completed
-
Vanderbilt UniversityAgency for Healthcare Research and Quality (AHRQ)Completed