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临床试验/NCT04606706
NCT04606706Unknown不适用

Development and Effectiveness of A Mobile Health-Based Education Intervention on Maternal, Infant and Young Child Nutrition to Prevent Stunting in Kelantan

Universiti Sains Malaysia2 个研究点 分布在 1 个国家目标入组 516 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
516
试验地点
2
主要终点
Assessment of socioeconomic status (SES) after 6 months of intervention among mother, infant and children

研究概览

简要总结

This research aimed to develop health module related to nutrition through mobile phone and to access it effectiveness among mother, infant and children (0-2 years old) to prevent stunting in Kelantan, Malaysia. Besides, to evaluate the effectiveness of intervention in reducing stress among pregnant and lactating women. The mobile health (mHealth) messaging interventions will be delivered via a mobile app known as WhatsApp and by a phone call. There will be a total of 50 messages for 6 months of intervention in which 2 messages will be delivered per week (every Tuesday & Thursday). The understanding of information will be evaluated 2 times per month by a phone call. The type of messages that will be used are text messages, voice messages, video/graphic messages, and voice calls. The assessment using a brief questionnaire and anthropometry measurement will be conducted during first and at the end of the intervention. The effectiveness and perceptions as well as experiences of mobile health intervention will also be assessed.

详细描述

A) Research Objectives

  1. General Objective

To evaluate the effectiveness of mobile health intervention program and to explore the perceptions and experiences of mobile health intervention among mothers to prevent stunting among infant and young children in Kelantan, Malaysia 2. Specific Objectives

Phase 1 - Development of a mobile health education package to prevent stunting among maternal, infant and young children

  1. To develop the mobile health education package for pregnant women, lactating mothers and mothers of young children in preventing stunting among children

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Pregnant women + husband
  • Pregnant women age 18-35 years during the study
  • Height (<155 cm)
  • or B40 (household income below Ringgit Malaysia (RM) 2194 in Kelantan)
  • or history of stunted child
  • or History Gestional Diabetes Mellitus (GDM), anemia, pre-eclampsia
  • In second trimester of pregnancy (13-16 weeks)
  • Attend the same selected health clinics for the regular medical check-up
  • Own a smart phone
  • Lactation mother + infant + husband
  • Lactation mother age 18-35 years during the study
  • Mother height (<155 cm)
  • or B40 (household income below RM 2194 in Kelantan)
  • or history of stunted child
  • New postnatal cases reported to the clinic after delivery
  • Attend the selected health clinics for the regular medical check-up
  • Own a smart phone
  • Children + mother + father
  • Children age 6-18 months
  • B40 (household income below RM2194 in Kelantan)
  • or stunted siblings
  • Full terms' babies (deliver after 37 weeks gestation)
  • Attend the selected health clinics for the regular medical check-up
  • Own a smart phone

排除标准

  • Pregnant women + husband
  • Multiple pregnancies
  • Lactation mother + infant + husband
  • Babies who have congenital problems/ birth defects
  • Stillbirth or foetal death after deliver
  • Children + mother + father
  • Children who have congenital problems/ birth defects
  • Single parent

结局指标

主要结局

Assessment of socioeconomic status (SES) after 6 months of intervention among mother, infant and children

时间窗: 6 months

Socioeconomic status (SES) in Ringgit Malaysia unit

Changes in body weight after 6 months of intervention among mother, infant and children

时间窗: 6 months

Body weight in kg

Changes in body mass index after 6 months of intervention among mother, infant and children

时间窗: 6 months

Body mass index in kg/m\^2

Changes in dietary intake after 6 months of intervention among mother, infant and children

时间窗: 6 months

24-hour diet recall (3-days) in kcal

Assessment of food security level after 6 months of intervention among mother, infant and children

时间窗: 6 months

Food security in score (All items are negative answer = secure; If one or more item have positive answer = insecure)

Changes in body composition after 6 months of intervention among mother, infant and children

时间窗: 6 months

Body composition in %

Assessment of mental stress after 6 months of intervention among mother, infant and children

时间窗: 6 months

Mental stress in score (Depression if score \>9; anxiety if score \> 7; stress if score \> 14)

次要结局

  • Changes in knowledge, attitude and practice of breastfeeding after 6 months of intervention among lactating mothers(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Norshafawati Binti Abd. Azimi

Principal investigator

Universiti Sains Malaysia

研究点 (2)

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