Clinical trial NCT06753669: Mothers' Action Project for Child Health
Official title: Mothers' Action Project for Child Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Caries
Obesity Risk
Keywords: early childhood caries
child obesity
social network intervention
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: National Institutes of Health (NIH)
First posted: 2024-12-31
Enrollment: 1260
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: MAP-CH is a cluster randomized clinical trial. A total of 180 proximally dwelling clusters of approximately 7 mothers will be randomized 1:1 to the intervention and control arms (90 clusters/arm). One child per family will be enrolled, resulting in a total sample size of 1260. The target population of this study is low-income SA mothers of young children aged 12-72 months.

Recruitment: To identify eligible families for recruitment, the MAP-CH research staff will conduct a Mapping Project. Community health workers (CHWs) 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 (24 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, 18M and T3. Dental caries assessments will occur at baseline and T3.

Analyses: The primary outcome is reduced d2-4mfs increment at 24 months' post baseline in the intervention compared to the control group. A secondary outcome is reduced weight gain. 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.

Eligibility criteria: Inclusion Criteria:

Mother:

1 age 18-45; 2)speaks and reads/writes Bengali or Hindi/Urdu; 3) mother born in a South Asian country; 4) mother is primary caretaker of child

Child:

Aged 12-48 months Has Medicaid or CHIP (NYS health plan for low income families not qualifying for Medicaid) -

Exclusion Criteria:

Mother:

1) unable to provide informed consent, 2) has plans to travel for \> month during first 12-month study period

Child:

1) weighed \< 5lbs at birth, 2) has an exclusionary health condition and/or is taking long term (\>1 m) antibiotics

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Primary outcomes:
measure: NIDCR ECC Collaborative Criteria Dental Exam
timeFrame: 24 months
Secondary outcomes:
measure: Weight Gain Velocity
timeFrame: 24 months
measure: Infant Feeding Styles Questionnaire--Adapted
timeFrame: 24 months
measure: Oral Hygiene and Dental Utilization Questionnaire
timeFrame: 24 months
measure: Food frequency Questionnaire
timeFrame: 24 months
measure: Dental utilization
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: UMass Chan
name: Alison Karasz
role: PRINCIPAL_INVESTIGATOR
References: