Recruiting

Child Health Education

Sponsor:

University of Massachusetts, Worcester

Code:

NCT06753669

Conditions

Dental Caries

Obesity Risk

Eligibility Criteria

Sex: All

Age: 1 - 45

Healthy Volunteers: Accepted

Interventions

health education and social network building

dental referral and educational materials

Study Details

Brief summary:

This randomized controlled trial will recruit Bangladeshi mothers and their young children into a 12 month intervention that provides child health and oral health education and seeks to build social networks among mothers.

Conditions

Dental Caries

Obesity Risk

Study ID

NCT06753669

Start date

Feb 1, 2026

Status verified date

Jan, 2026

Completion date

Mar 30, 2029

Anticipated

Primary completion date

Feb 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Mother:

  • Age >=18;
  • Speaks and reads/writes Bengali or Hindi/Urdu;
  • Mother born in a South Asian country;
  • Mother is primary caretaker of child
  • Child:

  • Aged >=12 and <=48 months
  • Has Medicaid or CHIP (NYS health plan for low income families not qualifying for Medicaid)

Exclusion Criteria:

  • Mother:

  • Unable to provide informed consent,
  • Lack of availability--either plans to travel for > 1 month during 12 month initial study period or other barriers to attendance;
  • Mother has exclusionary health condition--either intellectual/cognitive or medical.
  • Child:

  • Weighed < 5lbs at birth,
  • Has an exclusionary health condition and/or is taking long term (>1 m) antibiotics;
  • Not the youngest eligible child in family

Study Design

Enrollment

460 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention arm

Referrals to vetted dentists, educational materials on child feeding and oral health, in person health education sessions and social network building

placebo comparator: Control Arm

The control arm will receive referrals to vetted dentists and educational materials on child feeding and oral health.

Interventions

health education and social network building

The investigators will use techniques from the social network literature to build each treatment group as a cohesive social network and will diffuse educational messages through these groups. Educational materials and vetted dentist referrals, plus navigation to dentist visits, will be provided.

dental referral and educational materials

Control arm will receive a referral to vetted dentist and educational materials on child health

Primary outcome measure

  • NIDCR ECC Collaborative Criteria Dental Exam [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Alison Karasz, PhD

347-843-5652alison.karasz@umassmed.edu

Christine Fountain

803-315-1780cfountain1@fordham.edu

Locations

UMass Chan Medical School - Remote field office

Recruiting

New York, New York, United States, 11205

Contacts

Alison Karasz

347-843-5652alison.karasz@umassmed.edu

Arundhati Debnath

arundhati.debnath@umassmed.edu

Principal Investigator:

Alison Karasz, PhD

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Apr 14, 2026

Last verified

Jan, 2026

Keywords

  • early childhood caries
  • child obesity
  • social network intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-04-14.