Pregnancy OutcomeNCT05760768
The Effect of Individualized Exercise Guidance on Pregnancy Outcome
A study testing Individualized exercise guidance in people with Pregnancy Outcome and Gestational Weight Gain, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
A single center, randomized controlled trial was conducted to investigate whether individualized exercise guidance was more effective in improving pregnancy outcomes in normal pregnant women. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Outcome, Gestational Weight Gain, Mediation
- What is being tested?
- Individualized exercise guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 30 Sep 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 45 years.
- With singleton pregnancy.
- Second trimester.
- No contraindications to exercise during pregnancy.
- Be able to use smart phone for chatting, read and write basic Chinese.
- Volunteer for research.
Who cannot join
- Adverse pregnancy reaction, such as abdominal pain, vaginal bleeding and so on.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of ob gyn, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: The Effect of Individualized Exercise Guidance on Pregnancy Outcome: A Prospective Randomized Controlled Trial
A single center, randomized controlled trial was conducted to investigate whether individualized exercise guidance was more effective in improving pregnancy outcomes in normal pregnant women. What's more, the trial was also conducted to find out whether there is a mediating effect between prenatal exercise and pregnancy outcomes.
Read the detailed description
Fetal macrosomia refers to newborns with a birth weight more than 4000 grams, which poses varying degrees of risks to the health of both mother and infant and also affects the health outcomes of future generations. Research has found that exercise can effectively reduce the incidence of macrosomia and prevent gestational diabetes mellitus, pregnancy-induced hypertension, and excessive weight gain during pregnancy. However, every pregnant woman's individual situation and exercise habits are different, and personalized guidance based on their own circumstances is necessary during pregnancy exercise. The use of intelligent devices for supervision and management is also essential. To explore the impact of personalized exercise guidance during pregnancy on macrosomia, as well as the mediating effect of weight gain during pregnancy on exercise and macrosomia, we conducted a prospective randomized controlled clinical trial. The study included pregnant women who were over 20 years old, married, singleton, in the mid-term of pregnancy, and had no contraindications for exercise during pregnancy. They were randomly divided into an individualized exercise guidance group and standard clinic prenatal care group. Both groups received routine prenatal care and did not have any special dietary recommendations. The pregnant women in the individualized exercise guidance group received regular exercise guidance from a professional teacher and were supervised and managed through a WeChat group. The main outcome indicators were the incidence of macrosomia and the total weight gain during pregnancy.
- Being tested
- Individualized exercise guidance
- Medical subject headings
- Gestational Weight Gain, Negotiating, Fetal Macrosomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized exercise guidanceBehavioural
Participants accept individualized exercise guidance. They are also managed continuously through WeChat group chat during prenatal clinical interval.
| Study group | Role | What they receive |
|---|---|---|
| Individualized exercise guidance group | Experimental | Participants accept individualized exercise guidance. They are also managed continuously through WeChat group chat during prenatal clinical interval. Receives: Behavioral: Individualized exercise guidance |
| Standard clinic prenatal care (control) group | No intervention | Participants accept regular routine prenatal care following Chinese standard. |
What is being measured
The primary outcome is the main question the study is designed to answer.
macrosomia
Neonatal birthweight is more than 4000 grams.
Measured: From date of enrollment until the date of delivery, assessed up to 28 weeks.
gestation weight gain（GWG）
Weight before delivery minus weight before pregnancy.
Measured: From date of enrollment until the date of delivery, assessed up to 28 weeks.
Secondary outcomes (2)
postpartum weight retention（PPWR）
Weight at a certain point after delivery minus weight before pregnancy.
Measured: From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.
diastasis recti abdominis（RDA）
The separation of the left and right rectus abdominis.
Measured: From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Dec 2021
- Primary completion31 Jan 2022
- Study completion30 Sep 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 Pregnancy OutcomeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liangkun Ma, Study director, Peking union medical college hosiptal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760768
- Sponsor's protocol ID
- 018
- Status last verified
- Nov 2021
- First submitted
- 20 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang X, Wang G, Liu N, Wang Y, Zhang S, Lin H, Zhu C, Liu L, Sun Y, Ma L. Mediating effect of gestational weight gain on the preventive effect of exercise during pregnancy on macrosomia: a randomized clinical trial. BMC Pregnancy Childbirth. 2024 May 22;24(1):384. doi: 10.1186/s12884-024-06527-7.
PubMed 38778289
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Individualized Exercise Guidance on Pregnancy Outcome: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05760768
- Acronym / sponsor ID
- 018
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 8 Mar 2023 (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.
A single center, randomized controlled trial was conducted to investigate whether individualized exercise guidance was more effective in improving pregnancy outcomes in normal pregnant women. What's more, the trial was also conducted to find out whether there is a mediating effect between prenatal exercise and pregnancy outcomes.
Detailed description
Fetal macrosomia refers to newborns with a birth weight more than 4000 grams, which poses varying degrees of risks to the health of both mother and infant and also affects the health outcomes of future generations. Research has found that exercise can effectively reduce the incidence of macrosomia and prevent gestational diabetes mellitus, pregnancy-induced hypertension, and excessive weight gain during pregnancy. However, every pregnant woman's individual situation and exercise habits are different, and personalized guidance based on their own circumstances is necessary during pregnancy exercise. The use of intelligent devices for supervision and management is also essential. To explore the impact of personalized exercise guidance during pregnancy on macrosomia, as well as the mediating effect of weight gain during pregnancy on exercise and macrosomia, we conducted a prospective randomized controlled clinical trial. The study included pregnant women who were over 20 years old, married, singleton, in the mid-term of pregnancy, and had no contraindications for exercise during pregnancy. They were randomly divided into an individualized exercise guidance group and standard clinic prenatal care group. Both groups received routine prenatal care and did not have any special dietary recommendations. The pregnant women in the individualized exercise guidance group received regular exercise guidance from a professional teacher and were supervised and managed through a WeChat group. The main outcome indicators were the incidence of macrosomia and the total weight gain during pregnancy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized exercise guidance group | Experimental | Behavioral: Individualized exercise guidanceParticipants accept individualized exercise guidance. They are also managed continuously through WeChat group chat during prenatal clinical interval. |
| Standard clinic prenatal care (control) group | No intervention | –Participants accept regular routine prenatal care following Chinese standard. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged between 18 and 45 years.
- With singleton pregnancy.
- Second trimester.
- No contraindications to exercise during pregnancy.
- Be able to use smart phone for chatting, read and write basic Chinese.
Key exclusion criteria (1 listed)
- Adverse pregnancy reaction, such as abdominal pain, vaginal bleeding and so on.
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 |
|---|---|---|
| Individualized exercise guidanceParticipants accept individualized exercise guidance. They are also managed continuously through WeChat group chat during prenatal clinical interval. | Behavioural | Individualized exercise guidance group |
Primary outcome
macrosomia
Time frame: From date of enrollment until the date of delivery, assessed up to 28 weeks.
Neonatal birthweight is more than 4000 grams.
gestation weight gain（GWG）
Time frame: From date of enrollment until the date of delivery, assessed up to 28 weeks.
Weight before delivery minus weight before pregnancy.
2 secondary outcomes
postpartum weight retention（PPWR）
Time frame: From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.
diastasis recti abdominis（RDA）
Time frame: From date of enrollment until the date of 42 days postpartum, assessed up to 34 weeks.
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 8 Mar 2023.
- Derived from this study: PubMed 38778289Yang X, Wang G, Liu N, Wang Y, Zhang S, Lin H, Zhu C, Liu L, Sun Y, Ma L. Mediating effect of gestational weight gain on the preventive effect of exercise during pregnancy on macrosomia: a randomized clinical trial. BMC Pregnancy Childbirth. 2024 May 22;24(1):384. doi: 10.1186/s12884-024-06527-7.
- 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.
Liangkun Ma study director
Peking union medical college hosiptal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized exercise guidance in people with Pregnancy Outcome and Gestational Weight Gain, run by Peking Union Medical College Hospital at 1 site in China.
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 6 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 8 Mar 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 China. 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?
macrosomia (time frame: From date of enrollment until the date of delivery, assessed up to 28 weeks.). The study lists 2 primary outcomes in all. 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 NCT05760768, 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 8 Mar 2023.