Cloud Platform Integration Model for Pregnant Women Exercise Consultation

Cloud Platform Integration Model for Pregnant Women Exercise Consultation: Development, Construction and Evaluation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related; Exercise
• Intervention / Treatment: Behavioral: exercise counselling

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: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ching Fang Lee, PhD; Phone Number: 1323 +886 26360323; Email: chingfang@mmc.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
increase physiacl activity	measure by pregnancy physical activity questionnaire	The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks) and third trimester (34-36 weeks)
decrese symptom distress	pregnancy related symptom distress scale	The data were collectedbefore the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks) and third trimester (34-36 weeks)
decrease pregnancy related complications	such as gestational diabetes, pregancy related hypertension, preclampsia, preterm labor.	The data were collectedbefore the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks) and third trimester (34-36 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
construct exercise counseling model	intergrate the could platform in exercise counseling for pregnant women	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

Collaborators and Investigators

• Sponsor: Mackay Medical College
• Investigators: Principal Investigator: Ching Fang Lee, PhD, Mackay Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: September 9, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; pregnancy; women; platform; exercise counselling
• Other Study ID Numbers: MOST 111-2410-H-715 -001 -MY3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No