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Clinical Trials/CTRI/2022/03/040973
CTRI/2022/03/040973Not ApplicableNot Applicable

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

Rosliza Abdul Manaf6 sites in 1 country322 target enrollmentStarted: September 5, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not Applicable
Sponsor
Enrollment
322
Locations
6
Primary Endpoint
To determine the effectiveness of ANE intervention module on exercise adherence among antenatal women in primary health care.

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 45.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

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

Time Frame: baseline, immediately post intervention and 1 month post intervention

Secondary Outcomes

  • -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)

Investigators

Sponsor
Rosliza Abdul Manaf
Sponsor Class
Other [self]

Study Sites (6)

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