Dental CariesMAP-CHNCT06753669
Mothers' Action Project for Child Health
A study testing health education and social network building and dental referral and educational materials in people with Dental Caries and Obesity Risk, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Obesity Risk
- What is being tested?
- health education and social network building and dental referral and educational materials
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to 30 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 months to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UMass Chan Medical School - Remote field office
New York, New York, 11205
Alison Karasz, 347-843-5652, alison.karasz@umassmed.edu
Arundhati Debnath, arundhati.debnath@umassmed.edu
About this study
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.
Read the 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.
- Conditions
- Dental Caries, Obesity Risk
- Being tested
- health education and social network building, dental referral and educational materials
- Keywords
- early childhood caries, child obesity, social network intervention
- Medical subject headings
- Dental Caries, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health education and social network buildingBehavioural
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 materialsBehavioural
Control arm will receive a referral to vetted dentist and educational materials on child health
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Referrals to vetted dentists, educational materials on child feeding and oral health, in person health education sessions and social network building Receives: 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. Receives: Behavioral: dental referral and educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 months
Dental utilization
Presence or absence of a dental visit AND # dental visits between baseline and 18 months
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Feb 2026
- Primary completion28 Feb 2029 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Alison Karasz, University of Massachusetts, Worcester
- Investigators
- Alison Karasz, Principal investigator, UMass Chan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753669
- Sponsor's protocol ID
- 00000666
- Other IDs
- UH3DE030070
- Acronym
- MAP-CH
- Status last verified
- Jan 2026
- First submitted
- 27 Oct 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographics, social network, and outcome data
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mothers' Action Project for Child Health
- ClinicalTrials.gov ID
- NCT06753669
- Acronym / sponsor ID
- MAP-CH / 00000666
- Conditions
- Dental Caries, Obesity Risk
- Keywords
- early childhood caries, child obesity, social network intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH)
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 31 Dec 2024 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: health education and social network buildingReferrals to vetted dentists, educational materials on child feeding and oral health, in person health education sessions and social network building |
| Control Arm | Placebo comparator | Behavioral: dental referral and educational materialsThe control arm will receive referrals to vetted dentists and educational materials on child feeding and oral health. |
Who may qualify
- Ages
- 12 months to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Mother:
- Child:
Key exclusion criteria (8 listed)
- Mother:
- Child:
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 |
|---|---|---|
| health education and social network buildingThe 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. | Behavioural | Intervention arm |
| dental referral and educational materialsControl arm will receive a referral to vetted dentist and educational materials on child health | Behavioural | Control Arm |
Primary outcome
NIDCR ECC Collaborative Criteria Dental Exam
Time frame: 18 months
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.
5 secondary outcomes
Weight Gain Velocity
Time frame: 18 months
Infant Feeding Styles Questionnaire--Adapted
Time frame: 18 months
Oral Hygiene and Dental Utilization Questionnaire
Time frame: 18 months
Food frequency Questionnaire
Time frame: 18 months
Dental utilization
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Yes. Demographics, social network, and outcome data
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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.
Alison Karasz principal investigator
UMass Chan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health education and social network building and dental referral and educational materials in people with Dental Caries and Obesity Risk, run by University of Massachusetts, Worcester at 1 site 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alison Karasz, PhD (347-843-5652, alison.karasz@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIDCR ECC Collaborative Criteria Dental Exam (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2026.