Mothers' Action Project for Child Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: health education and social network building, dental referral and educational materials.
- Who it may be relevant to
- Registry conditions: Dental Caries, Obesity Risk. Basic parameters: 12 months — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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. - Behavioral dental referral and educational materials
Control arm will receive a referral to vetted dentist and educational materials on child health
Primary outcome measures
- NIDCR ECC Collaborative Criteria Dental Exam [Time frame: 18 months]
Secondary outcome measures (5)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- UMass Chan Medical School - Remote field office — New York
Identifiers
NCT: NCT06753669 · 00000666 · UH3DE030070