NCT06753669

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Feb 2026Mar 2029

First Submitted

Initial submission to the registry

October 27, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2029

Last Updated

April 14, 2026

Status Verified

January 1, 2026

Enrollment Period

3.1 years

First QC Date

October 27, 2024

Last Update Submit

April 9, 2026

Conditions

Dental CariesObesity Risk

Keywords

early childhood carieschild obesitysocial network intervention

Outcome Measures

Primary Outcomes (1)

  • NIDCR ECC Collaborative Criteria Dental Exam

    The investigators will assess 18 month incidence in dental caries using dental hygienist exams at baseline and 18 months post baseline. The exams will be conducted in the home, in the knee to knee position or on the floor, using artificial light and a front plane mirror. The teeth will be dry brushed and wiped. An explorer will be used to remove debris to visualize the tooth surface except as specified for the assessment of hardness. No magnification will be allowed. The examiner will use a trained recorder.

    18 months

Secondary Outcomes (5)

  • Weight Gain Velocity

    18 months

  • Infant Feeding Styles Questionnaire--Adapted

    18 months

  • Oral Hygiene and Dental Utilization Questionnaire

    18 months

  • Food frequency Questionnaire

    18 months

  • Dental utilization

    18 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Behavioral: health education and social network building

Control Arm

PLACEBO COMPARATOR

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

Behavioral: dental referral and educational materials

Interventions

health education and social network buildingBEHAVIORAL

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.

Intervention arm
dental referral and educational materialsBEHAVIORAL

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

Control Arm

Eligibility Criteria

Age12 Months - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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;
  • Child:
  • Weighed \< 5lbs at birth,
  • Not the youngest eligible child in family

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Chan Medical School - Remote field office

New York, New York, 11205, United States

RECRUITING

MeSH Terms

Conditions

Dental CariesPediatric Obesity

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alison Karasz

    UMass Chan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison Karasz, PhD

CONTACT

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

Christine Fountain

CONTACT

803-315-1780cfountain1@fordham.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 27, 2024

First Posted

December 31, 2024

Study Start

February 1, 2026

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

March 30, 2029

Last Updated

April 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Demographics, social network, and outcome data

Shared Documents
SAP
Time Frame
Data will be available indefinitely as soon as all study analyses are complete
Access Criteria
Qualified researcher with a clear analysis plan

Locations

US(1)