Mothers' Action Project for Child Health (MAP-CH)

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Caries; Obesity Risk
• Intervention / Treatment: Behavioral: dental referral and educational materials; Behavioral: health education and social network building

Detailed Description

MAP-CH is a cluster randomized clinical trial. A total of 66 proximally dwelling clusters of approximately 7 mothers will be randomized 1:1 to the intervention and control arms (33 clusters/arm). One child per family will be enrolled, resulting in a total sample size of 460. The target population of this study is low-income SA mothers of young children aged 12-66 months.

Recruitment: To identify eligible families for recruitment, the MAP-CH research staff will conduct a Mapping Project. Outreach workers will identify clusters of eligible families living close together in SA neighborhoods. Accompanied by local contacts project staff will visit homes of potential participants and assess eligibility and recruit eligible consenting mothers.

Intervention: Mothers assigned to the intervention group will participate in a 12-month, multi-session, group-based intervention. Intervention meetings will take place in participant homes and will be led in Bengali (or the language spoken by that cluster), by a skilled bilingual facilitator from our research staff. The intervention is designed to: 1) improve knowledge, attitudes, and behaviors related to reducing dietary sugar; and 2) increase maternal assertiveness and parenting skills related to healthy feeding; and 3) build lasting social networks supportive of these norms and behaviors among participants. Eighteen sessions will be delivered over 12 months.

Control group: Mothers assigned to the control arm will receive a series of packages and mailings.

Data collection: Interviews will be conducted in the home, by RAs at T1/Baseline, T2 (12months' post baseline) and T3 (18 months' post baseline). Data collected at each interview includes anthropometric data collection; and questionnaires/interviews. Social network data will also be collected at T1, 3M, 6M, T1, and T3. Dental caries assessments will occur at baseline and T3.

Analyses: The primary outcome is reduced d2-4mfs increment at 18 months' post baseline in the intervention compared to the control group. A secondary outcome is reduced weight gain velocity. Other outcomes include servings of sweetened foods and beverages, servings of junk food, use of bottles, maternal feeding behaviors, oral hygiene, and dental utilization. The investigators will also evaluate potential mediators and moderators of treatment impact including knowledge, assertiveness, depression, household empowerment, and social network quality.

• Study Type: Interventional
• Enrollment (Estimated): 460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alison Karasz, PhD; Phone Number: 347-843-5652; Email: alison.karasz@umassmed.edu
• Study Contact Backup: Name: Christine Fountain; Phone Number: 803-315-1780; Email: cfountain1@fordham.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 11205
      • Recruiting
      • UMass Chan Medical School - Remote field office
      • Contact: Alison Karasz; Phone Number: 347-843-5652; Email: alison.karasz@umassmed.edu
      • Contact: Arundhati Debnath; Email: arundhati.debnath@umassmed.edu
      • Principal Investigator: Alison Karasz, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Arm; The control arm will receive referrals to vetted dentists and educational materials on child feeding and oral health.	Behavioral: dental referral and educational materials; Control arm will receive a referral to vetted dentist and educational materials on child health
Experimental: Intervention arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Gain Velocity	We will measure child weight and height/length at 0, 12 and 18 months. Research staff will obtain weight and height data at baseline, 12 and 18 m. For children under 24 months of age, two supine measures will be taken using infantometers (Seca 417), to the nearest 0.1 cm. For children ≥24 months, a stadiometer will be used. If measurements differ by +/- 0.5 cm., a third measure will be taken, and the means averaged. Research quality scales will be used to assess weight. Primary outcome is change in weight/height over 18 months.	18 months
Infant Feeding Styles Questionnaire--Adapted	This measure assesses maternal feeding style, including pressured feeding. The original measure has been heavily adapted for the current population. The scale includes 19 items. The score ranges from 0 to 76 with a higher score indicating more problematic feeding styles.	18 months
Oral Hygiene and Dental Utilization Questionnaire	This 25 Item inventory, adapted for a previous study with a similar population, includes subscales covering the following domains: holding a bottle, sleeping with a bottle, tooth brushing, toothpaste, tap water, dental visits.	18 months
Food frequency Questionnaire	This seven day food frequency questionnaire has been adapted for use in the current study. It includes a variety of subscales focusing on food items relevant to weight gain and dental health including breast milk, formula, cows milk, sweetened beverages, sweets, junk food/snacks, and fruits/vegetables.	18 months
Dental utilization	Presence or absence of a dental visit AND # dental visits between baseline and 18 months	18 months

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Institutes of Health (NIH); National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Alison Karasz, UMass Chan

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: October 27, 2024
• First Submitted That Met QC Criteria: December 28, 2024
• First Posted (Actual): December 31, 2024

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: child obesity; early childhood caries; social network intervention
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Nutrition Disorders; Overnutrition; Body Weight; Tooth Diseases; Overweight; Obesity; Tooth Demineralization; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity; Dental Caries
• Other Study ID Numbers: 00000666; UH3DE030070 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Demographics, social network, and outcome data
• IPD Sharing Time Frame: Data will be available indefinitely as soon as all study analyses are complete
• IPD Sharing Access Criteria: Qualified researcher with a clear analysis plan
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No