This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cloud Platform Integration Model for Pregnant Women Exercise Consultation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 9, 2023
First Posted Date  ICMJE September 25, 2023
Last Update Posted Date September 25, 2023
Estimated Study Start Date  ICMJE December 15, 2023
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2023)
  • 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
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2023)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cloud Platform Integration Model for Pregnant Women Exercise Consultation
Official Title  ICMJE Cloud Platform Integration Model for Pregnant Women Exercise Consultation: Development, Construction and Evaluation
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Exercise
  • Pregnancy Related
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: exercise counselling
  • No Intervention: control group
    The control group will receive standard antenatal treatments without intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2023)
154
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2025
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ching Fang Lee, PhD +886 26360323 ext 1323 chingfang@mmc.edu.tw
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06053151
Other Study ID Numbers  ICMJE MOST 111-2410-H-715 -001 -MY3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Chin-Tsung Shen, Mackay Medical College
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mackay Medical College
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ching Fang Lee, PhD Mackay Medical College
PRS Account Mackay Medical College
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP