Pediatric ObesityCHALONCT03077425
Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach
A study testing Intervention in people with Pediatric Obesity and Early Childhood Caries, run by Albert Einstein College of Medicine at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Early Childhood Caries
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 8 sitesUnited States
- Study dates
- 7 Dec 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Healthy Kids Pediatric Group
East Windsor, New Jersey, 08520
Smart Medical Care
Jamaica, New York, 11417
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Dr. Masub's Medical and Dental Office
Queens, New York, 11106
Morris Heights Health Center
The Bronx, New York, 10453
Jacobi Medical Center
The Bronx, New York, 10461
Montefiore Medical Group
The Bronx, New York, 10462
North Central Bronx Hospital
The Bronx, New York, 10467
About this study
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.
Read the 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.
- Conditions
- Pediatric Obesity, Early Childhood Caries
- Being tested
- Enhanced Usual Care (EUC), Intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Usual Care (EUC)Behavioural
Per Arm/Group Description, CHWs will provide a pamphlet and dental referral list to participants both groups.
InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months of age (final follow-up [T2])
Secondary outcomes (13)
Added Sweeteners/Solids (Common Risk/Behavioral)
Number of sweeteners and/or solids/day added to child's sippy sups/bottles, obtained by RA
Measured: 18 months of age (final follow-up [T2])
Fruits & Vegetables (Common Risk/Behavioral)
Frequency of servings/day obtained by RA assessment using MySmileBuddy
Measured: 18 months of age (final follow-up [T2])
Juice & Sweet Drinks (Common Risk/Behavioral)
Frequency of servings/day obtained by RA assessment using MySmileBuddy
Measured: 18 months of age (final follow-up [T2])
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
Measured: 18 months of age (final follow-up [T2])
Sweet & Salty Snacks (Common Risk/Behavioral)
Frequency of servings obtained by RA assessment using MySmileBuddy
Measured: 18 months of age (final follow-up [T2])
Physical Activity (Obesity/Behavioral)
Time child spent in active play, assessed by parent completed questionnaire
Measured: 18 months of age (final follow-up [T2])
Screen Time (Obesity/Behavioral)
Time child spent in front of TV, computer, iPaD, or phone, assessed by parent completed questionnaire
Measured: 18 months of age (final follow-up [T2])
Tooth Brushing (Caries/Behavioral)
Frequency of parent wiping/brushing teeth, assessed by parent completed questionnaire
Measured: 18 months of age (final follow-up [T2])
Dental Visits (Caries/Behavioral)
Number of dental visits (child), assessed by parent completed questionnaire
Measured: 18 months of age (final follow-up [T2])
Visible Caries
Any visible caries by intra-oral camera (yes/No)
Measured: 18 months of age (T2).
Caries Severity
dfs index
Measured: 18 months of age (T2)
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
Measured: 18 months of age (T2)
Change in Weight Velocity Z Scores
Weight velocity Z scores: for each 6 month period: 6 m.>12 m. 12 m.>18m
Measured: see above
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start7 Dec 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Rutgers University, University of Rochester
- Responsible party
- Sponsor
- Investigators
- Alison Karasz, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077425
- Sponsor's protocol ID
- 2016-6156
- Acronym
- CHALO
- Status last verified
- Jul 2022
- First submitted
- 2 Mar 2017
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Debnath A, Bonuck K, Gao Q, Ramachandran U, Gaur S, Custodio-Lumsden CL, Kopycka-Kedzierawski DT, Kim M, Karasz A. The CHALO! Study Results of a Randomized Controlled Trial to Reduce Risk of Childhood Dental Caries and Obesity. Int J Environ Res Public Health. 2026 Jun 25;23(7):837. doi: 10.3390/ijerph23070837.
PubMed 42512142Karasz 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.
PubMed 29855352
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach
- ClinicalTrials.gov ID
- NCT03077425
- Acronym / sponsor ID
- CHALO / 2016-6156
- Conditions
- Pediatric Obesity, Early Childhood Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Columbia University, Rutgers University, University of Rochester
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionAn 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). |
| Enhanced Usual Care (EUC) | Placebo comparator | Behavioral: 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. |
Who may qualify
- Ages
- 3 months to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Usual Care (EUC)Per Arm/Group Description, CHWs will provide a pamphlet and dental referral list to participants both groups. | Behavioural | Enhanced Usual Care (EUC) |
| InterventionPer 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. | Behavioural | Intervention |
Primary outcome
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
13 secondary outcomes
Added Sweeteners/Solids (Common Risk/Behavioral)
Time frame: 18 months of age (final follow-up [T2])
Fruits & Vegetables (Common Risk/Behavioral)
Time frame: 18 months of age (final follow-up [T2])
Juice & Sweet Drinks (Common Risk/Behavioral)
Time frame: 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])
Sweet & Salty Snacks (Common Risk/Behavioral)
Time frame: 18 months of age (final follow-up [T2])
Physical Activity (Obesity/Behavioral)
Time frame: 18 months of age (final follow-up [T2])
Screen Time (Obesity/Behavioral)
Time frame: 18 months of age (final follow-up [T2])
Tooth Brushing (Caries/Behavioral)
Time frame: 18 months of age (final follow-up [T2])
Dental Visits (Caries/Behavioral)
Time frame: 18 months of age (final follow-up [T2])
Visible Caries
Time frame: 18 months of age (T2).
Caries Severity
Time frame: 18 months of age (T2)
Weight-for-length
Time frame: 18 months of age (T2)
Change in Weight Velocity Z Scores
Time frame: see above
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Derived from this study: PubMed 42512142Debnath A, Bonuck K, Gao Q, Ramachandran U, Gaur S, Custodio-Lumsden CL, Kopycka-Kedzierawski DT, Kim M, Karasz A. The CHALO! Study Results of a Randomized Controlled Trial to Reduce Risk of Childhood Dental Caries and Obesity. Int J Environ Res Public Health. 2026 Jun 25;23(7):837. doi: 10.3390/ijerph23070837.
- Derived from this study: PubMed 29855352Karasz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Karasz principal investigator
Albert Einstein College of Medicine
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Pediatric Obesity and Early Childhood Caries, run by Albert Einstein College of Medicine at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of (Combined) Sippy Cup and/or Bottles (Common Risk/Behavioral) (time frame: 18 months of age (final follow-up [T2])). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03077425, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.