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临床试验/NCT04045002
NCT04045002Unknown不适用

Development and Effectiveness of 'MyPinkMom' Educational Intervention With Anaemia in Petaling District

Universiti Kebangsaan Malaysia Medical Centre0 个研究点目标入组 120 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
主要终点
haemoglobin level changes

研究概览

简要总结

This study will use cluster randomised controlled trial design. It will be conducted at four antenatal clinics in Petaling district, Selangor, Malaysia. Two antenatal clinics will be randomised as intervention group. Other two antenatal clinics will be the control group. The investigators will recruit 60 participants from intervention and 60 participants from control group to evaluate effectiveness of 'MyPinkMom' educational intervention. Participants from intervention group will receive usual antenatal care and 'MyPinkMom' educational intervention through WhatsApp application, while those from control group receive usual antenatal care only. The outcome measurements are mean haemoglobin level, knowledge score, Theory of Planned Behaviour (TPB) construct and dietary iron intake between intervention and control group.

详细描述

General objective:

To assess the effectiveness of 'MyPinkMom' educational intervention in terms of knowledge on anaemia in pregnancy, Theory of Planned Behaviour (TPB) construct to adherence of daily iron tablet intake, haemoglobin level, and dietary iron intake among pregnant women with anaemia in Petaling district.

Specific objectives:

  1. To determine mean knowledge score on anaemia in pregnancy, Theory of Planned Behaviour (TPB) construct on adherence to daily iron intake, haemoglobin level and dietary iron intake of respondents from intervention and control group at baseline.
  2. To compare knowledge on anaemia in pregnancy between respondents in intervention and control groups at baseline, at 2 weeks and 6 weeks after educational intervention.
  3. To compare TPB construct on adherence to daily iron intake between respondents in intervention and control groups at baseline, 2 weeks and 6 weeks after educational intervention.
  4. To compare haemoglobin levels between respondents from intervention and control groups at baseline, 2 weeks and 6 weeks after educational intervention.
  5. To compare dietary iron, vitamin C and caffeine intake between respondents from intervention and control group at baseline, 2 weeks and 4 weeks after educational intervention.

Design:

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)

盲法说明

Respondents and investigators will aware the intervention received by respondents. The data analysers who assess research outcomes will be blinded as they would not know respondents belongs to intervention or control group as each respondent will be labelled as numbers.

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 20-40 years old
  • Women with pregnancy at 13-28 weeks gestation
  • Women diagnosed with anaemia with haemoglobin 7.0-10.9g/dl
  • Able to read and write in Malay and/or English
  • Participants have a smartphone installed with WhatsApp application

排除标准

  • Symptomatic anaemia (breathlessness, chest pain, syncope, signs of heart failure)
  • Anaemia due to thalassemia or other haematological disease
  • Anaemia due to other diseases such as renal failure or cancer
  • Planned for termination of pregnancy

结局指标

主要结局

haemoglobin level changes

时间窗: From baseline to week 8 (6 weeks post intervention)

Haemoglobin level will be measure at baseline, at week 4 (2 weeks post intervention) and at week 8 (6 weeks post intervention). Change from baseline haemoglobin level at week 8 (6 weeks post intervention) between intervention and control groups will be evaluated. Haemoglobin level will be traced from full blood count result from respondents' antenatal cards or laboratory. Blood for full blood count is taken by trained staff respective clinics for every monthly antenatal visit.

次要结局

  • knowledge score changes(From baseline to week 8 (6 weeks post intervention))
  • Amount of dietary iron changes(From baseline to week 8 (6 weeks post intervention))
  • Theory of Planned Behavior construct score changes(From baseline to week 8 (6 weeks post intervention))

研究者

发起方
Universiti Kebangsaan Malaysia Medical Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raudah Abd Rahman

Principal Investigator

Universiti Kebangsaan Malaysia Medical Centre

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