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Идёт набор NCT06753669

Mothers' Action Project for Child Health

Без фазы С лечением Dental Caries Obesity Risk

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: health education and social network building, dental referral and educational materials.
Кому может быть актуально
Состояния в реестре: Dental Caries, Obesity Risk. Базовые параметры: 12 мес. — 45 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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.
  • Поведенческое dental referral and educational materials
    Control arm will receive a referral to vetted dentist and educational materials on child health

Первичные конечные точки

  • NIDCR ECC Collaborative Criteria Dental Exam [Срок оценки: 18 months]
Вторичные конечные точки (5)
  • Weight Gain Velocity [Срок оценки: 18 months]
  • Infant Feeding Styles Questionnaire--Adapted [Срок оценки: 18 months]
  • Oral Hygiene and Dental Utilization Questionnaire [Срок оценки: 18 months]
  • Food frequency Questionnaire [Срок оценки: 18 months]
  • Dental utilization [Срок оценки: 18 months]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • UMass Chan Medical School - Remote field office — New York

Идентификаторы

NCT: NCT06753669 · 00000666 · UH3DE030070

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗