跳至主要内容
临床试验/NCT06753669
NCT06753669招募中不适用

Mothers' Action Project for Child Health

University of Massachusetts, Worcester1 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2026年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
460
试验地点
1
主要终点
NIDCR ECC Collaborative Criteria Dental Exam

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Months 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age >=18;
  • Speaks and reads/writes Bengali or Hindi/Urdu;
  • Mother born in a South Asian country;
  • Mother is primary caretaker of child
  • Aged >=12 and <=48 months
  • Has Medicaid or CHIP (NYS health plan for low income families not qualifying for Medicaid)

排除标准

  • 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.
  • 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

研究组 & 干预措施

Intervention arm

Experimental

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

干预措施: health education and social network building (Behavioral)

Control Arm

Placebo Comparator

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

干预措施: dental referral and educational materials (Behavioral)

结局指标

主要结局

NIDCR ECC Collaborative Criteria Dental Exam

时间窗: 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.

次要结局

  • Weight Gain Velocity(18 months)
  • Infant Feeding Styles Questionnaire--Adapted(18 months)
  • Oral Hygiene and Dental Utilization Questionnaire(18 months)
  • Food frequency Questionnaire(18 months)
  • Dental utilization(18 months)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alison Karasz

Professor

University of Massachusetts, Worcester

研究点 (1)

Loading locations...

相似试验