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Cloud Platform Integration Model for Pregnant Women Exercise Consultation

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ClinicalTrials.gov Identifier: NCT06053151
Recruitment Status : Not yet recruiting
First Posted : September 25, 2023
Last Update Posted : September 25, 2023
Sponsor:
Information provided by (Responsible Party):
Chin-Tsung Shen, Mackay Medical College

Brief Summary:
To construct the platform for exercise counseling for pregnant women, and evaluate the effects of that telecare platform integration model for exercise consultation on exercise behaviors and prenatal health outcomes among pregnant women during pregnancy.

Condition or disease Intervention/treatment Phase
Exercise Pregnancy Related Behavioral: exercise counselling Not Applicable

Detailed Description:
This study will develop and construct an exercise counseling model with using cloud platform for women during pregnancy. In addition, we will evaluate the effects of that telecare platform integration model for exercise consultation on exercise behaviors and prenatal health outcomes among pregnant women during pregnancy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Cloud Platform Integration Model for Pregnant Women Exercise Consultation: Development, Construction and Evaluation
Estimated Study Start Date : December 15, 2023
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arm Intervention/treatment
Experimental: experiemental group
The experimental group will receive the cloud platform integration model for exercise consultation intervention for two phases continue 24 weeks to promote exercise behavior during pregnancy.
Behavioral: exercise counselling
. The experimental group will receive the cloud platform integration model for exercise consultation intervention for two phases continue 24 weeks to promote exercise behavior during pregnancy. The goal of the first phase was to start regular exercise, and the goal of the second phase was to continue regular exercise.

No Intervention: control group
The control group will receive standard antenatal treatments without intervention.



Primary Outcome Measures :
  1. increase physiacl activity [ Time Frame: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks) and third trimester (34-36 weeks) ]
    measure by pregnancy physical activity questionnaire

  2. decrese symptom distress [ Time Frame: The data were collectedbefore the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks) and third trimester (34-36 weeks) ]
    pregnancy related symptom distress scale

  3. decrease pregnancy related complications [ Time Frame: The data were collectedbefore the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks) and third trimester (34-36 weeks) ]
    such as gestational diabetes, pregancy related hypertension, preclampsia, preterm labor.


Secondary Outcome Measures :
  1. construct exercise counseling model [ Time Frame: The data will be collected from pregnant women and experts perspectives; From date of first participant attend the focus group until the date of the last experts meeting , assessed up to 12 months ]
    intergrate the could platform in exercise counseling for pregnant women



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant women who less than 17 gestation and able to understand basic technologies such as smartphone and computer

Exclusion Criteria:

  • women who had a diagnosis of pregnancy related compliactions and absolute limited exercise, such as preterm contraction, ruputer of menbrance, evidence of intrauterus growth retardation, heart and lung disease, cervical incompetence and/or medical conditions that influence exercise.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06053151


Contacts
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Contact: Ching Fang Lee, PhD +886 26360323 ext 1323 chingfang@mmc.edu.tw

Sponsors and Collaborators
Mackay Medical College
Investigators
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Principal Investigator: Ching Fang Lee, PhD Mackay Medical College
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Responsible Party: Chin-Tsung Shen, head of administion, Mackay Medical College
ClinicalTrials.gov Identifier: NCT06053151    
Other Study ID Numbers: MOST 111-2410-H-715 -001 -MY3
First Posted: September 25, 2023    Key Record Dates
Last Update Posted: September 25, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chin-Tsung Shen, Mackay Medical College:
exercise counselling
pregnancy
women
platform
physical activity