Gestational Weight GainNCT04553718
Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women During Pregnancy
A study testing experimental group in people with Gestational Weight Gain and Physical Activity, run by Mackay Medical College at 1 site in Taiwan.
Trial summary
This study was to construct and develop an application (APP) based on social-cognitive theory for overweight and obese women during pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Weight Gain, Physical Activity
- What is being tested?
- experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2018to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant women--who have had, for 8-12 weeks, a pre-pregnancy body mass index of more than 25 kg/m2
Who cannot join
- high risk pregnancy, such as pre-clampsia, pregnancy induced hypertension, preterm contraction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women --Develop Applications With Wearable Devices
This study was to construct and develop an application (APP) based on social-cognitive theory for overweight and obese women during pregnancy.
Read the detailed description
Our program used and evaluated the mHealth program, which has pregnant women using APP and wearable devices to help prevent excessive gestational weight gain, and it continued to promote physical activity for overweight and obese pregnant women.
- Conditions
- Gestational Weight Gain, Physical Activity
- Being tested
- experimental group
- Keywords
- overweight, obese, pregnant women
- Medical subject headings
- Gestational Weight Gain, Motor Activity, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupOther
provide mHealth program, which has pregnant women using wearable device and app
| Study group | Role | What they receive |
|---|---|---|
| experiemental group | Experimental | Experimental group was the mHealth app to improved their gestational weight gain and physical activity during pregnancy. Receives: Other: experimental group |
| control group | No intervention | standard prenatal care and without mHealth app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manage gestational weight gain
control excessive gestational weight gain
Measured: 4-6 week
Secondary outcomes (1)
Increase physical activity level
increase the scores of pregnancy of physical activity questionnaire
Measured: 4-6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 Aug 2018
- Primary completion1 Aug 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin-Tsung Shen, Mackay Medical College
- Investigators
- Ching Fang Lee, PhD, Principal investigator, Mackay Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553718
- Sponsor's protocol ID
- MackayMedical
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2020
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women --Develop Applications With Wearable Devices
- ClinicalTrials.gov ID
- NCT04553718
- Acronym / sponsor ID
- MackayMedical
- Conditions
- Gestational Weight Gain, Physical Activity
- Keywords
- overweight, obese, pregnant women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Mackay Medical CollegeUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was to construct and develop an application (APP) based on social-cognitive theory for overweight and obese women during pregnancy.
Detailed description
Our program used and evaluated the mHealth program, which has pregnant women using APP and wearable devices to help prevent excessive gestational weight gain, and it continued to promote physical activity for overweight and obese pregnant women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized control trial
| Arm | Type | Receives |
|---|---|---|
| experiemental group | Experimental | Other: experimental groupExperimental group was the mHealth app to improved their gestational weight gain and physical activity during pregnancy. |
| control group | No intervention | –standard prenatal care and without mHealth app |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant women--who have had, for 8-12 weeks, a pre-pregnancy body mass index of more than 25 kg/m2
Key exclusion criteria (1 listed)
- high risk pregnancy, such as pre-clampsia, pregnancy induced hypertension, preterm contraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental groupprovide mHealth program, which has pregnant women using wearable device and app | Other | experiemental group |
Primary outcome
Manage gestational weight gain
Time frame: 4-6 week
control excessive gestational weight gain
1 secondary outcome
Increase physical activity level
Time frame: 4-6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching Fang Lee, PhD principal investigator
Mackay Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental group in people with Gestational Weight Gain and Physical Activity, run by Mackay Medical College at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manage gestational weight gain (time frame: 4-6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.