跳至主要内容
临床试验/CTRI/2022/03/040973
CTRI/2022/03/040973Not Applicable不适用

Effectiveness Of Antenatal Exercise Intervention Using Behavioral Theory On ExerciseAdherence Among Antenatal Women In Kuala Selangor District

Rosliza Abdul Manaf6 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2022年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
Not Applicable
发起方
入组人数
322
试验地点
6
主要终点
To determine the effectiveness of ANE intervention module on exercise adherence among antenatal women in primary health care.

研究概览

简要总结

This study is a cluster randomized, single blind, parallel group to determine the effectiveness of antenatal exercise module intervention using behavioral theory on exercise adherence among 322 antenatal women in six primary health care clinics in Selangor, Malaysia. The primary outcome measures will be a significant differences on exercise adherence at immediately post intervention and 1 month post intervention between intervention and control group. The secondary outcomes will be a significant differences on information, motivation, behavioral skills and HRQOL at immediately post intervention and 1 month post intervention between intervention and control group.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • •Antenatal women:.
  • •at 12-16 weeks of gestation.
  • •who did not actively exercise or attend any antenatal exercise class during current pregnancy.
  • •who owned smart mobile phone.
  • •who able to read and understand the Malay language.
  • •who will continue their check-up in the same clinic during their pregnancy.

排除标准

  • •Antenatal women who presented and/or diagnosed with medical or obstetric complications (heart problem, thyroid disease, multiple pregnancies, high blood pressure, diabetes, anaemia, asthma, epilepsy, and cervical incompetence) and serious psychological conditions that could have impacted the reliability of information.
  • •High risk pregnancy (contraindications to exercise e.g. placenta previa, persistent bleeding, cervical incompetence).
  • •Non singleton pregnancy.
  • •High risk for preterm delivery (birth before 37 weeks) such as twin pregnancy.

结局指标

主要结局

To determine the effectiveness of ANE intervention module on exercise adherence among antenatal women in primary health care.

时间窗: baseline, immediately post intervention and 1 month post intervention

次要结局

  • -To determine the effectiveness of ANE intervention module on information, motivation and behavioural skills (perceived benefits, perceived barriers and exercise self-efficacy)(-To determine the effectiveness of ANE intervention module on HRQOL)

研究者

发起方
Rosliza Abdul Manaf
申办方类型
Other [self]

研究点 (6)

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