Cloud Platform Integration Model for Pregnant Women Exercise Consultation

Study Overview
=================
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.

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

Conditions
-----------------
Exercise, Pregnancy Related

Intervention / Treatment
-----------------
* Behavioral: exercise counselling


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experiemental group<br>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<br>* . 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.<br>|
| No Intervention: control group<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise counselling, pregnancy, women, platform, physical activity