Cloud Platform Integration Model for Pregnant Women Exercise Consultation

Sponsor
Mackay Medical College (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06053151
Collaborator
(none)
154
2
19.5

Study Details

Study Description

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
  • Behavioral: exercise counselling
N/A

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 Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Dec 15, 2023
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. increase physiacl activity [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mackay Medical College

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Sep 25, 2023
Last Update Posted:
Sep 25, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chin-Tsung Shen, head of administion, Mackay Medical College

Study Results

No Results Posted as of Sep 25, 2023