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

University of Massachusetts, Worcester

Status: Not yet enrolling

Conditions: Dental Caries; Obesity Risk

Treatments: Behavioral: dental referral and educational materials; Behavioral: health education and social network building

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06753669

00000666

UH3DE030070 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 460 estimated patients

Sex: All

Ages: 12 months to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

460 participants in 2 patient groups, including a placebo group

Intervention arm

Experimental group

Description:

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

Treatment:

Behavioral: health education and social network building

Control Arm

Placebo Comparator group

Description:

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

Treatment:

Behavioral: dental referral and educational materials