mHealth InterventionNCT05022680
The Effects of Peer-led Walking Intervention With mHealth Technology
A study testing mhealth in people with mHealth Intervention, run by Chin-Tsung Shen at 1 site in Taiwan.
Trial summary
This study will apply the peer-led walking intervention with mHealth technology to maintain physical activity and promote prenatal health. Moreover, the participants of the trained peer mentors support women walking with mHealth technology, which has pregnant women using the APP to set goals, self-monitor, and… 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
- mHealth Intervention
- What is being tested?
- mhealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2021to 31 Dec 2022
- 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
- women who had a pre-pregnancy body mass index of more than 25 kg/m2
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Peer-led Walking Intervention With mHealth Technology for Physical Activity and Prenatal Health Outcomes
This study will apply the peer-led walking intervention with mHealth technology to maintain physical activity and promote prenatal health. Moreover, the participants of the trained peer mentors support women walking with mHealth technology, which has pregnant women using the APP to set goals, self-monitor, and self-manage, and it will continue to promote physical activity for overweight and obese pregnant women
Read the detailed description
This study was to investigate the effectiveness of peer-led walking intervention with mHealth technology on physical activity, self-efficacy, weekly steps, exercise involvement and depression status. Participants of the trained peer mentors encourage women walking with mHealth technology, which has pregnant women using the APP to set goals, self-record, and self-monitor, and it will continue to promote physical activity for overweight and obese pregnant women.This study's results will be useful to healthcare providers who need to promote physical exercise and an active lifestyle for overweight and obese pregnant women.
- Conditions
- mHealth Intervention
- Being tested
- mhealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mhealthBehavioural
the peer-led intervention with mHealth technology (an application (APP) and Sports bracelet)
| Study group | Role | What they receive |
|---|---|---|
| Participants were used app to record their diet and steps every day | Experimental | Experimental group was the mHealth with peer led to improved their physical activity during pregnancy. Participants received app to record and monitor their physical activity every days and using it until childbirth. Receives: Behavioral: mhealth |
| non-mhealth | No intervention | control group was the traditional prenatal care during pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity
physical activity (pregnancy physical activity questionnaire)
Measured: throughout childbirth, average of 20-30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 May 2021
- Primary completion1 Aug 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for mHealth InterventionStudies 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
- randomize control trial
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chin-Tsung Shen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chin-Tsung Shen, Mackay Medical College
- Investigators
- Ching-Fang Lee, PhD, Principal investigator, Mackay Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022680
- Sponsor's protocol ID
- LCF MOST 109-110
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2021
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang JP, Chen HH, Lee CF, Chi LK, Tsai JM, Chen PJ. Effects of Peer-Led Walking With mHealth Technology on Exercise Behavior of Women With Overweight and Obesity From Pregnancy to Early Postpartum: A Randomized Controlled Trial. Worldviews Evid Based Nurs. 2026 Feb;23(1):e70100. doi: 10.1111/wvn.70100.
PubMed 41715266
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Peer-led Walking Intervention With mHealth Technology for Physical Activity and Prenatal Health Outcomes
- ClinicalTrials.gov ID
- NCT05022680
- Acronym / sponsor ID
- LCF MOST 109-110
- Conditions
- mHealth Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Chin-Tsung ShenUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Aug 2021 (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 will apply the peer-led walking intervention with mHealth technology to maintain physical activity and promote prenatal health. Moreover, the participants of the trained peer mentors support women walking with mHealth technology, which has pregnant women using the APP to set goals, self-monitor, and self-manage, and it will continue to promote physical activity for overweight and obese pregnant women
Detailed description
This study was to investigate the effectiveness of peer-led walking intervention with mHealth technology on physical activity, self-efficacy, weekly steps, exercise involvement and depression status. Participants of the trained peer mentors encourage women walking with mHealth technology, which has pregnant women using the APP to set goals, self-record, and self-monitor, and it will continue to promote physical activity for overweight and obese pregnant women.This study's results will be useful to healthcare providers who need to promote physical exercise and an active lifestyle 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
- randomize control trial
| Arm | Type | Receives |
|---|---|---|
| Participants were used app to record their diet and steps every day | Experimental | Behavioral: mhealthExperimental group was the mHealth with peer led to improved their physical activity during pregnancy. Participants received app to record and monitor their physical activity every days and using it until childbirth. |
| non-mhealth | No intervention | –control group was the traditional prenatal care during pregnancy. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women who had a pre-pregnancy body mass index of more than 25 kg/m2
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| mhealththe peer-led intervention with mHealth technology (an application (APP) and Sports bracelet) | Behavioural | Participants were used app to record their diet and steps every day |
Primary outcome
physical activity
Time frame: throughout childbirth, average of 20-30 weeks
physical activity (pregnancy physical activity questionnaire)
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 18 Jul 2023.
- Derived from this study: PubMed 41715266Huang JP, Chen HH, Lee CF, Chi LK, Tsai JM, Chen PJ. Effects of Peer-Led Walking With mHealth Technology on Exercise Behavior of Women With Overweight and Obesity From Pregnancy to Early Postpartum: A Randomized Controlled Trial. Worldviews Evid Based Nurs. 2026 Feb;23(1):e70100. doi: 10.1111/wvn.70100.
- 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 mhealth in people with mHealth Intervention, run by Chin-Tsung Shen 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 18 Jul 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?
physical activity (time frame: throughout childbirth, average of 20-30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05022680, which also lists 1 linked publication.
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 18 Jul 2023.