Overweight and Obese Pregnant WomenNCT04553731
The Effects of mHealth Intervention on Health Empower of Overweight and Obese Women's Body Weight During Pregnancy
A study testing empowerment program with mHealth in people with Overweight and Obese Pregnant Women, run by Mackay Medical College at 1 site in Taiwan.
Trial summary
evaluate the health empowerment program with mHealth to promote physical activity for overweight and obese pregnant women. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Overweight and Obese Pregnant Women
- What is being tested?
- empowerment program with mHealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 31 Jul 2021
- 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
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women--who have had, 8-12 weeks
- pre-pregnancy body mass index > 25 kg/m2
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
evaluate the health empowerment program with mHealth to promote physical activity for overweight and obese pregnant women.
Read the detailed description
This two-phase study develops an mhealth application (app) based on social-cognitive theory (SCT) and evaluates its effectiveness for overweight and obese women, which can help to prevent excessive GWG by enhancing optimal weight and healthy behavior during pregnancy.
- Conditions
- Overweight and Obese Pregnant Women
- Being tested
- empowerment program with mHealth
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empowerment program with mHealthBehavioural
empowerment program with mHealth
| Study group | Role | What they receive |
|---|---|---|
| The mHealth-based program | Experimental | The experimental group used the mHealth app and Mi Smart Band 5 on managing and preventing excessive GWG among overweight and obese women during pregnancy Receives: Behavioral: empowerment program with mHealth |
| The standard antenatal treatments with no mHealth-based elements | No intervention | controls received standard antenatal treatments with no mHealth-based elements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight and gestational weight gain from pregnancy to 6 months postpartum
measure body weight and calculated according to the IOM guidelines to know their the total and weekly values of excess or achieve the IOM's guidelines.
Measured: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks), third trimester (34-36 weeks), 6 months postpartum
Secondary outcomes (3)
Change in physical activity before intervention to childbirth
pregnancy physical activity questionnaire (PPAQ) was used to measure women's physical activity during pregnancy.
Measured: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks), third trimester (34-36 weeks); The highest total scores was depend the participants' activities of METs.
self-efficacy related weight gain
self-efficacy in exercise and diet was used to measure
Measured: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks), third trimester (34-36 weeks); The highest total scores was 125.
control infant birthweight
measure infant birthweight
Measured: The data were collected at childbirth
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 Jan 2020
- Primary completion31 Dec 2020
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and Obese Pregnant WomenStudies 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
- Masking
- None (open label)
- Enrolment
- 92 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
- NCT04553731
- Sponsor's protocol ID
- LCF-MOST107
- Status last verified
- Jul 2023
- First submitted
- 11 Sep 2020
- 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
Chen HH, Hsiung Y, Lee CF, Huang JP, Chi LK, Weng SS. Effects of an mHealth intervention on maternal and infant outcomes from pregnancy to early postpartum for women with overweight or obesity: A randomized controlled trial. Midwifery. 2024 Nov;138:104143. doi: 10.1016/j.midw.2024.104143. Epub 2024 Aug 11.
PubMed 39154597Chen HH, Lee CF, Huang JP, Hsiung Y, Chi LK. Effectiveness of a nurse-led mHealth app to prevent excessive gestational weight gain among overweight and obese women: A randomized controlled trial. J Nurs Scholarsh. 2023 Jan;55(1):304-318. doi: 10.1111/jnu.12813. Epub 2022 Sep 19.
PubMed 36121127
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 mHealth Intervention on Health Empower of Overweight and Obese Women's Body Weight During Pregnancy
- ClinicalTrials.gov ID
- NCT04553731
- Acronym / sponsor ID
- LCF-MOST107
- Conditions
- Overweight and Obese Pregnant Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Mackay Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Jul 2021 (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.
evaluate the health empowerment program with mHealth to promote physical activity for overweight and obese pregnant women.
Detailed description
This two-phase study develops an mhealth application (app) based on social-cognitive theory (SCT) and evaluates its effectiveness for overweight and obese women, which can help to prevent excessive GWG by enhancing optimal weight and healthy behavior during pregnancy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The mHealth-based program | Experimental | Behavioral: empowerment program with mHealthThe experimental group used the mHealth app and Mi Smart Band 5 on managing and preventing excessive GWG among overweight and obese women during pregnancy |
| The standard antenatal treatments with no mHealth-based elements | No intervention | –controls received standard antenatal treatments with no mHealth-based elements |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pregnant women--who have had, 8-12 weeks
- pre-pregnancy body mass index > 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 |
|---|---|---|
| empowerment program with mHealthempowerment program with mHealth | Behavioural | The mHealth-based program |
Primary outcome
Change in body weight and gestational weight gain from pregnancy to 6 months postpartum
Time frame: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks), third trimester (34-36 weeks), 6 months postpartum
measure body weight and calculated according to the IOM guidelines to know their the total and weekly values of excess or achieve the IOM's guidelines.
3 secondary outcomes
Change in physical activity before intervention to childbirth
Time frame: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks), third trimester (34-36 weeks); The highest total scores was depend the participants' activities of METs.
self-efficacy related weight gain
Time frame: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks), third trimester (34-36 weeks); The highest total scores was 125.
control infant birthweight
Time frame: The data were collected at childbirth
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 39154597Chen HH, Hsiung Y, Lee CF, Huang JP, Chi LK, Weng SS. Effects of an mHealth intervention on maternal and infant outcomes from pregnancy to early postpartum for women with overweight or obesity: A randomized controlled trial. Midwifery. 2024 Nov;138:104143. doi: 10.1016/j.midw.2024.104143. Epub 2024 Aug 11.
- Derived from this study: PubMed 36121127Chen HH, Lee CF, Huang JP, Hsiung Y, Chi LK. Effectiveness of a nurse-led mHealth app to prevent excessive gestational weight gain among overweight and obese women: A randomized controlled trial. J Nurs Scholarsh. 2023 Jan;55(1):304-318. doi: 10.1111/jnu.12813. Epub 2022 Sep 19.
- 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 empowerment program with mHealth in people with Overweight and Obese Pregnant Women, 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 2 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?
Change in body weight and gestational weight gain from pregnancy to 6 months postpartum (time frame: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks), third trimester (34-36 weeks), 6 months postpartum). 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 NCT04553731, which also lists 2 linked publications.
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.