Body ImageNCT05042349
Pregnant Elite Athletes and Pregnant Women Exercising With Moderate Intensity
An observational study of Body Image and Physical Activity, run by Norwegian School of Sport Sciences at 1 site in Norway.
Trial summary
The aim of this study is to 1. register possible changes to uteroplacental circulation in relation to physical tests, 2. to register energy and nutritional intake, relationship towards the body during pregnancy and during the early period after giving birth, 3. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Image, Physical Activity, Exercise
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2020to 1 May 2025
- Phase
- Observational
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The sample represents 1. pregnant female elite athletes, 2. pregnant females who are only moderately physically active, 3. the athletes sponsors, 4. the athletes coach/team leader.
Who may be able to join
- Athletes: pregnant female pregnant elite athletes at a recruiting team, junior or senior, who represent athletes within endurance, weight sensitive, ball sports, and technical sports.
- Controls/reference group: pregnant females who are moderately physically active.
- For both groups: age 18-40 år.
Who cannot join
- Known illness or disease, which defines their pregnancy as a high-risk pregnancy
- Age >40 years old.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to 1. register possible changes to uteroplacental circulation in relation to physical tests, 2. to register energy and nutritional intake, relationship towards the body during pregnancy and during the early period after giving birth, 3. register the experience of guidance given related to exercise, nutrition, and recovery, 4. register elite athletes' experience of combining the role of being a mom and an elite athlete, and 5. register attitudes and reactions from the support system when it comes to being an elite athlete and being pregnant. Material and method: 30 pregnant female elite athletes and 30 moderately physically active pregnant women will be recruited for the completion of physical testing and questionnaires and questionnaires only, respectively. 20 national team leaders/coaches and 10 sponsors will be recruited for a semi-structured interview about attitudes, reactions and guidance towards athletes who become pregnant and still wish to continue their career as an athlete after pregnancy.
Read the detailed description
The aim of this study is to 1. register possible changes to uteroplacental circulation in relation to physical tests, 2. to register energy and nutritional intake, relationship towards the body during pregnancy and during the early period after giving birth, 3. register the experience of guidance given related to exercise, nutrition, and recovery, 4. register elite athletes' experience of combining the role of being a mom and an elite athlete, and 5. register attitudes and reactions from the support system when it comes to being an elite athlete and being pregnant. Material and method: It is expected that we can include 30 pregnant female elite athletes for the physiological testing who also will complete the questionnaires included in the study. In addition, 30 moderately physically active pregnant women will be recruited for the completion of the questionnaires only. Both groups answer questions related to exercise, pregnancy related issues, nutrition and their relationship towards their body. To obtain enough participants, data collection will continue for five years. During the same period, 20 national team leaders/coaches and 10 sponsors will be recruited for a semi-structured interview. The physiological testing will be conducted during the 23-29th week of pregnancy. The athletes will conduct a running test and resistance tests in the lab. The following measures will be registered: pulsatility index (PI) and volume blood flow in both uterine arteries, 2. the fetus' pulsatility index (PI) in the umbilical cord artery and heart rate frequency, 3. body temperature, heart rate, blood pressure and saturation in the mother during rest and during physical exertion. Data on gestational development and birth will be collected based on information given by the participant herself and by birth records and health records. Coaches/leaders and sponsors will in their interview, answer to questions related to attitudes, reactions and guidance of athletes who become pregnant and still wish to continue their career as an athlete after pregnancy.
- Conditions
- Body Image, Physical Activity, Exercise, Energy Intake, Nutritional Status, Pregnancy Related
- Keywords
- Pregnancy, Elite athlete, Fetus, Physical health, Mental health
- Medical subject headings
- Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elite athletes | Pregnant female elite athletes | |
| Controls | Moderately physical active pregnant females | |
| Sponsors | Sponsors of the athletes | |
| Coaches/tema leaders | Coaches or team leaders of the atheltes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise
Self-developed questions about exercise volume before, during, and after pregnancy. Participants respond to open ended questions and questions with yes/no and multiple response options.
Measured: 5 minutes
Fertility and pregnancy related issues
Participants respond to open ended questions and questions with yes/no and multiple response options.
Measured: 5 minutes
Nutrition
Questionnaire. Four days of dietary registration during, where participants respond both to questions with Likert scales, YES/NO, and multiple response options, 1st, 2nd, 3rd trimester, and 3 months after delivery.
Measured: 5 minutes
Secondary outcomes (8)
Pulsatility index
Ultrasound
Measured: 15 minutes
Volume blood flow
Ultrasound
Measured: 5 minutes
Heart rate frequency
Heart rate monitor
Measured: 5 minutes
Body temperature
Thermometer
Measured: 5 minutes
Blood pressure
Sphygmomanometer
Measured: 10 minutes
Attitudes, reactions and guidance of athletes who become pregnant and still wish to continue their career as an athlete after pregnancy
Participants respond to open ended questions and questions with yes/no and multiple response options.
Measured: 5 minutes
Satisfaction with life
Satisfaction with life scale. 5 items answered on a 7-point Likert scale, where higher sum score indicates higher satisfaction with life
Measured: 1 minute
Beck's Depression Inventory (BDI-IA)
Questionnaire where five questions are answered to on a 6-point Likert scale, with higher score indocates higher level of depressive symptoms.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Jun 2020 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body ImageStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Jorunn Sundgot-Borgen, Norwegian School of Sport Sciences
- Investigators
- Jorunn Sundgot-Borgen, PhD, Principal investigator, Norwegian School of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042349
- Sponsor's protocol ID
- 125635
- Status last verified
- Nov 2023
- First submitted
- 4 Sep 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnant Elite Athletes and Pregnant Women Exercising With Moderate Intensity
- ClinicalTrials.gov ID
- NCT05042349
- Acronym / sponsor ID
- 125635
- Conditions
- Body Image, Physical Activity, Exercise, Energy Intake, Nutritional Status, Pregnancy Related
- Keywords
- Pregnancy, Elite athlete, Fetus, Physical health, Mental health
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 13 Sep 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.
The aim of this study is to 1. register possible changes to uteroplacental circulation in relation to physical tests, 2. to register energy and nutritional intake, relationship towards the body during pregnancy and during the early period after giving birth, 3. register the experience of guidance given related to exercise, nutrition, and recovery, 4. register elite athletes' experience of combining the role of being a mom and an elite athlete, and 5. register attitudes and reactions from the support system when it comes to being an elite athlete and being pregnant. Material and method: 30 pregnant female elite athletes and 30 moderately physically active pregnant women will be recruited for the completion of physical testing and questionnaires and questionnaires only, respectively. 20 national team leaders/coaches and 10 sponsors will be recruited for a semi-structured interview about attitudes, reactions and guidance towards athletes who become pregnant and still wish to continue their career as an athlete after pregnancy.
Detailed description
The aim of this study is to 1. register possible changes to uteroplacental circulation in relation to physical tests, 2. to register energy and nutritional intake, relationship towards the body during pregnancy and during the early period after giving birth, 3. register the experience of guidance given related to exercise, nutrition, and recovery, 4. register elite athletes' experience of combining the role of being a mom and an elite athlete, and 5. register attitudes and reactions from the support system when it comes to being an elite athlete and being pregnant. Material and method: It is expected that we can include 30 pregnant female elite athletes for the physiological testing who also will complete the questionnaires included in the study. In addition, 30 moderately physically active pregnant women will be recruited for the completion of the questionnaires only. Both groups answer questions related to exercise, pregnancy related issues, nutrition and their relationship towards their body. To obtain enough participants, data collection will continue for five years. During the same period, 20 national team leaders/coaches and 10 sponsors will be recruited for a semi-structured interview. The physiological testing will be conducted during the 23-29th week of pregnancy. The athletes will conduct a running test and resistance tests in the lab. The following measures will be registered: pulsatility index (PI) and volume blood flow in both uterine arteries, 2. the fetus' pulsatility index (PI) in the umbilical cord artery and heart rate frequency, 3. body temperature, heart rate, blood pressure and saturation in the mother during rest and during physical exertion. Data on gestational development and birth will be collected based on information given by the participant herself and by birth records and health records. Coaches/leaders and sponsors will in their interview, answer to questions related to attitudes, reactions and guidance of athletes who become pregnant and still wish to continue their career as an athlete after pregnancy.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Elite athletes | – | –Pregnant female elite athletes |
| Controls | – | –Moderately physical active pregnant females |
| Sponsors | – | –Sponsors of the athletes |
| Coaches/tema leaders | – | –Coaches or team leaders of the atheltes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The sample represents 1. pregnant female elite athletes, 2. pregnant females who are only moderately physically active, 3. the athletes sponsors, 4. the athletes coach/team leader.
Key inclusion criteria (3 listed)
- Athletes: pregnant female pregnant elite athletes at a recruiting team, junior or senior, who represent athletes within endurance, weight sensitive, ball sports, and technical sports.
- Controls/reference group: pregnant females who are moderately physically active.
- For both groups: age 18-40 år.
Key exclusion criteria (2 listed)
- Known illness or disease, which defines their pregnancy as a high-risk pregnancy
- Age >40 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exercise
Time frame: 5 minutes
Self-developed questions about exercise volume before, during, and after pregnancy. Participants respond to open ended questions and questions with yes/no and multiple response options.
Fertility and pregnancy related issues
Time frame: 5 minutes
Participants respond to open ended questions and questions with yes/no and multiple response options.
Nutrition
Time frame: 5 minutes
Questionnaire. Four days of dietary registration during, where participants respond both to questions with Likert scales, YES/NO, and multiple response options, 1st, 2nd, 3rd trimester, and 3 months after delivery.
8 secondary outcomes
Pulsatility index
Time frame: 15 minutes
Volume blood flow
Time frame: 5 minutes
Heart rate frequency
Time frame: 5 minutes
Body temperature
Time frame: 5 minutes
Blood pressure
Time frame: 10 minutes
Attitudes, reactions and guidance of athletes who become pregnant and still wish to continue their career as an athlete after pregnancy
Time frame: 5 minutes
Satisfaction with life
Time frame: 1 minute
Beck's Depression Inventory (BDI-IA)
Time frame: 1 minute
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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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.
Jorunn Sundgot-Borgen, PhD principal investigator
Norwegian School of Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Image and Physical Activity, run by Norwegian School of Sport Sciences at 1 site in Norway.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 13 Nov 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 Norway. 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 was withdrawn before enrolling participants, so there are no results.
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?
Exercise (time frame: 5 minutes). The study lists 3 primary outcomes in all. 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 Nov 2023.