Hypertension ,PregnancyNCT07678944
Impact of Exercise Prescription on Obstetric and Neonatal Outcomes
A study testing Physical activity plan and Women who received information but did not engaged in a physical activity routine in people with Hypertension ,Pregnancy and Diabetes During Pregnancy, run by Unidade Local de Saúde de Coimbra, EPE at 1 site in Portugal.
Trial summary
The aim of this study is to assess the impact of structured physical activity with smartwatch remote monitoring on glycemic control, blood pressure control, obstetric complications and neonatal outcomes in women with GDM, chronic hypertension and obesity. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Hypertension ,Pregnancy, Diabetes During Pregnancy, Obesity (BMI>30)
- What is being tested?
- Physical activity plan and Women who received information but did not engaged in a physical activity routine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Feb 2024to 1 Aug 2025
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women aged 16 years or older with a confirmed diagnosis of gestational diabetes (fasting blood glucose greater than 92 mg/dL in first trimester; or values in the oral glucose tolerance test in second trimester greater than 92/180/153 mg/dL, respectively at 0 hours, 1 hour after glucose ingestion, and 2 hours after)
- Pregnant women aged 16 or older with chronic hypertension or a history of bariatric surgery and pre-pregnancy Body Mass Index (BMI) above 30Kg/m2.
- Eligibility further required consistent clinical adherence defined as attending all schedule appointments with the obstetric team without unjustified absences
Who cannot join
- multiple gestations
- risk of preterm labor
- history of premature delivery due to a non-maternal cause
- persistent vaginal bleeding
- placenta previa beyond 28 weeks' gestation
- cervical insufficiency
- any limiting systemic, respiratory or cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess the impact of structured physical activity with smartwatch remote monitoring on glycemic control, blood pressure control, obstetric complications and neonatal outcomes in women with GDM, chronic hypertension and obesity. A prospective, longitudinal, single-arm intervention study with 310 pregnant women was conducted over a period of 18 months. Participants received individualized exercise prescriptions based on international guidelines, complemented by smartwatch monitoring and regular telephonic feedback. Outcomes were compared between subgroups of women who adhere to the recommended exercise guidelines and those who did not, across three high-risk populations (GDM, chronic hypertension and obesity).
Read the detailed description
A prospective, longitudinal, single-arm, intervention (prospective cohort) study was conducted in the Obstetric Department of Hospital of Coimbra, Portugal, for a total period of 18 months after a one-year recruitment period between February 2024 and January 2025, with data collection continuing until the final participant had given birth.
Clinical monitoring for high-risk pregnancies takes place solely in a hospital setting. This includes at least monthly visits and standardized trimester ultrasounds, with supplementary scans schedule as needed for fetal development and well-being based on the underlying conditions.
All pregnant patients attending their first obstetric consultation for either Endocrinology/Obstetric (if diagnosis of gestational diabetes or obesity with previous bariatric surgery) or Hypertension/Obstetric (if chronic hypertension) were recruited for the trial.
Study participants were enrolled via screening referrals initiated by both internal or external healthcare providers.
At the first visit, pregnant women were notified of an upcoming telephone contact from the research team. After clinical record verification, a phone interview was conducted to explain the project and collect demographic, anthropometric and obstetric data. After confirming the absence of exercise contraindications, researchers assessed the participants' pre-pregnancy healthy lifestyle habits.
Subsequently, participants received proactive counselling on the exercise modalities most effective for their specific pathologies, including guidance on the intensity, frequency and duration required for optimal health outcomes. This intervention included information on local exercise facilities and access to digital platforms (YouTube Channel - Active Pregnancy) featuring safe, evidence-based activities tailored for pregnancy. Prescriptions were individualized, incorporating patient preferences to determine the most suitable activity types and schedules.
Participants were equipped with a smartwatch to monitor physical activity, specifically tracking heart rate, step count, distance and average speed throughout the pregnancy. They were instructed to activate the device's 'training' mode at the commencement of each exercise session. Subsequently, activity data were synced to a dedicated mobile application for later extraction and analysis from the research team.
Follow-up telephonic consultations were conducted every 3-6 weeks to promote exercise adherence. During these calls, the research team characterized the participants' previous activity levels and adjusted prescriptions based on individual tolerability and evolving interests. These contacts persisted until delivery, the emerge of a medical contraindication or at the participants request.
Informational posters were displayed throughout the institution to highlight the primary advantages of prenatal physical activity. These materials included a link to dedicated social media platform design specifically for this study, intended to educate patients, dispel prevalent myths such as the unsubstantiated link between exercise and miscarriage or preterm birth and provide localized information on community exercise facilities and safe home-based workout routines.
The study was conducted in accordance with the Declaration of Helsinki and applicable national regulations for healthcare research and was approved by the Ethics Committee of the Institution (PI OBS.SF.112-2023). Informed consent was obtained from all individual participants. All materials and clinical appointments were provided without any costs for the participants, and all data were collected by healthcare professionals and processed anonymously to ensure participant confidentiality.
- Being tested
- Physical activity plan, Women who received information but did not engaged in a physical activity routine
- Keywords
- Gestational Diabetes, Chronic hypertension, Obesity, Prenatal exercise, Smartwatch monitoring, Digital health, High-risk pregnancy, Physical activity intervention
- Medical subject headings
- Hypertension, Pregnancy-Induced, Diabetes, Gestational, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity planBehavioural
pregnant women who engaged in a physical activity routine previously prescribed
Women who received information but did not engaged in a physical activity routineBehavioural
No structured physical activity
| Study group | Role | What they receive |
|---|---|---|
| women who adhere to the recommended exercise prescription | Active comparator | Subsequently, participants received proactive counselling on the exercise modalities most effective for their specific pathologies, including guidance on the intensity, frequency and duration required for optimal health outcomes. This intervention included information on local exercise facilities and access to digital platforms (YouTube Channel - Active Pregnancy) featuring safe, evidence-based activities tailored for pregnancy. Prescriptions were individualized, incorporating patient preferences to determine the most suitable activity types and schedules.
Participants were equipped with a smartwatch to monitor physical activity, specifically tracking heart rate, step count, distance and average speed throughout the pregnancy. They were instructed to activate the device's 'training' mode at the commencement of each exercise session. Subsequently, activity data were synced to a dedicated mobile application for later extraction and analysis from the research team. Receives: Behavioral: Physical activity plan |
| women who did not adhere to the recommended exercise prescription | Placebo comparator | Pregnant women who despite the active recommendation did not adhere to the prescribed physical activity plan Receives: Behavioral: Women who received information but did not engaged in a physical activity routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Controlled chronic hypertension
Chronic hypertension was categorized as poorly controlled when medication adjustments or new therapies were necessary to achieve blood pressure values below the 140/90 mmHg threshold
Measured: From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.
Glycemic control
Glycemic control was categorized as uncontrolled if pharmacological intervention was required to meet clinical targets typically defined as having more than five weekly blood glucose readings outside the recommended range (fasting plasma glucose ≥ 95 mg/dL and/or 1-hour postprandial glucose ≥ 140 mg/dL) and no association with alimentary mistakes.
Measured: From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.
Excessive weight gain
Excessive weight gain was defined according to the Portuguese Directorate General of Health (DGS) guidelines (more than 18kg for women with pre-pregnancy BMI<18.5 kg/m 2 ; more than 16kg if previous BMI between 18.5-24.9 kg/m 2 ; more than 11.5kg if previous BMI between 25-29.9 kg/m 2 ; and more than 9kg if previous BMI above 30 kg/m 2 )
Measured: From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.
Secondary outcomes (3)
Preterm delivery
Preterm birth was considered if deliver occurred before 37 weeks of gestational age
Measured: Diagnosed after delivery
Low Birth weight
Low birth weight was defined as a birth weight of less than 2500g.
Measured: Data available at one point, after delivery
Pre eclampsia
Pre eclampsia was defined as a condition that pregnant women develop after 20-weeks gestational age, with new-onset hypertension, usually with accompanying proteinuria, intrauterine growth restriction or other analytic anomalies as elevated liver enzymes, low platelet count or hemolysis.
Measured: After diagnosis until delivery, up to 20 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Feb 2024
- Primary completion1 Feb 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension ,PregnancyStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPE
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filipa Coutinho, Unidade Local de Saúde de Coimbra, EPE
- Investigators
- Filipa M Coutinho, MD, Principal investigator, Unidade Local de Saúde de Coimbra, EPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678944
- Sponsor's protocol ID
- ULSCoimbra
- Status last verified
- Jan 2025
- First submitted
- 19 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: and all data were collected by healthcare professionals and processed anonymously to ensure participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise Prescription on Obstetric and Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT07678944
- Acronym / sponsor ID
- ULSCoimbra
- Keywords
- Gestational Diabetes, Chronic hypertension, Obesity, Prenatal exercise, Smartwatch monitoring, Digital health, High-risk pregnancy, Physical activity intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPEUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 1 Jul 2026 (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 assess the impact of structured physical activity with smartwatch remote monitoring on glycemic control, blood pressure control, obstetric complications and neonatal outcomes in women with GDM, chronic hypertension and obesity. A prospective, longitudinal, single-arm intervention study with 310 pregnant women was conducted over a period of 18 months. Participants received individualized exercise prescriptions based on international guidelines, complemented by smartwatch monitoring and regular telephonic feedback. Outcomes were compared between subgroups of women who adhere to the recommended exercise guidelines and those who did not, across three high-risk populations (GDM, chronic hypertension and obesity).
Detailed description
A prospective, longitudinal, single-arm, intervention (prospective cohort) study was conducted in the Obstetric Department of Hospital of Coimbra, Portugal, for a total period of 18 months after a one-year recruitment period between February 2024 and January 2025, with data collection continuing until the final participant had given birth.
Clinical monitoring for high-risk pregnancies takes place solely in a hospital setting. This includes at least monthly visits and standardized trimester ultrasounds, with supplementary scans schedule as needed for fetal development and well-being based on the underlying conditions.
All pregnant patients attending their first obstetric consultation for either Endocrinology/Obstetric (if diagnosis of gestational diabetes or obesity with previous bariatric surgery) or Hypertension/Obstetric (if chronic hypertension) were recruited for the trial.
Study participants were enrolled via screening referrals initiated by both internal or external healthcare providers.
At the first visit, pregnant women were notified of an upcoming telephone contact from the research team. After clinical record verification, a phone interview was conducted to explain the project and collect demographic, anthropometric and obstetric data. After confirming the absence of exercise contraindications, researchers assessed the participants' pre-pregnancy healthy lifestyle habits.
Subsequently, participants received proactive counselling on the exercise modalities most effective for their specific pathologies, including guidance on the intensity, frequency and duration required for optimal health outcomes. This intervention included information on local exercise facilities and access to digital platforms (YouTube Channel - Active Pregnancy) featuring safe, evidence-based activities tailored for pregnancy. Prescriptions were individualized, incorporating patient preferences to determine the most suitable activity types and schedules.
Participants were equipped with a smartwatch to monitor physical activity, specifically tracking heart rate, step count, distance and average speed throughout the pregnancy. They were instructed to activate the device's 'training' mode at the commencement of each exercise session. Subsequently, activity data were synced to a dedicated mobile application for later extraction and analysis from the research team.
Follow-up telephonic consultations were conducted every 3-6 weeks to promote exercise adherence. During these calls, the research team characterized the participants' previous activity levels and adjusted prescriptions based on individual tolerability and evolving interests. These contacts persisted until delivery, the emerge of a medical contraindication or at the participants request.
Informational posters were displayed throughout the institution to highlight the primary advantages of prenatal physical activity. These materials included a link to dedicated social media platform design specifically for this study, intended to educate patients, dispel prevalent myths such as the unsubstantiated link between exercise and miscarriage or preterm birth and provide localized information on community exercise facilities and safe home-based workout routines.
The study was conducted in accordance with the Declaration of Helsinki and applicable national regulations for healthcare research and was approved by the Ethics Committee of the Institution (PI OBS.SF.112-2023). Informed consent was obtained from all individual participants. All materials and clinical appointments were provided without any costs for the participants, and all data were collected by healthcare professionals and processed anonymously to ensure participant confidentiality.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women who adhere to the recommended exercise prescription | Active comparator | Behavioral: Physical activity planSubsequently, participants received proactive counselling on the exercise modalities most effective for their specific pathologies, including guidance on the intensity, frequency and duration required for optimal health outcomes. This intervention included information on local exercise facilities and access to digital platforms (YouTube Channel - Active Pregnancy) featuring safe, evidence-based activities tailored for pregnancy. Prescriptions were individualized, incorporating patient preferences to determine the most suitable activity types and schedules. Participants were equipped with a smartwatch to monitor physical activity, specifically tracking heart rate, step count, distance and average speed throughout the pregnancy. They were instructed to activate the device's 'training' mode at the commencement of each exercise session. Subsequently, activity data were synced to a dedicated mobile application for later extraction and analysis from the research team. |
| women who did not adhere to the recommended exercise prescription | Placebo comparator | Behavioral: Women who received information but did not engaged in a physical activity routinePregnant women who despite the active recommendation did not adhere to the prescribed physical activity plan |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women aged 16 years or older with a confirmed diagnosis of gestational diabetes (fasting blood glucose greater than 92 mg/dL in first trimester; or values in the oral glucose tolerance test in second trimester greater than 92/180/153 mg/dL, respectively at 0 hours, 1 hour after glucose ingestion, and 2 hours after)
- Pregnant women aged 16 or older with chronic hypertension or a history of bariatric surgery and pre-pregnancy Body Mass Index (BMI) above 30Kg/m2.
- Eligibility further required consistent clinical adherence defined as attending all schedule appointments with the obstetric team without unjustified absences
Key exclusion criteria (7 listed)
- multiple gestations
- risk of preterm labor
- history of premature delivery due to a non-maternal cause
- persistent vaginal bleeding
- placenta previa beyond 28 weeks' gestation
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 |
|---|---|---|
| Physical activity planpregnant women who engaged in a physical activity routine previously prescribed | Behavioural | women who adhere to the recommended exercise prescription |
| Women who received information but did not engaged in a physical activity routineNo structured physical activity | Behavioural | women who did not adhere to the recommended exercise prescription |
Primary outcome
Controlled chronic hypertension
Time frame: From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.
Chronic hypertension was categorized as poorly controlled when medication adjustments or new therapies were necessary to achieve blood pressure values below the 140/90 mmHg threshold
Glycemic control
Time frame: From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.
Glycemic control was categorized as uncontrolled if pharmacological intervention was required to meet clinical targets typically defined as having more than five weekly blood glucose readings outside the recommended range (fasting plasma glucose ≥ 95 mg/dL and/or 1-hour postprandial glucose ≥ 140 mg/dL) and no association with alimentary mistakes.
Excessive weight gain
Time frame: From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.
Excessive weight gain was defined according to the Portuguese Directorate General of Health (DGS) guidelines (more than 18kg for women with pre-pregnancy BMI<18.5 kg/m 2 ; more than 16kg if previous BMI between 18.5-24.9 kg/m 2 ; more than 11.5kg if previous BMI between 25-29.9 kg/m 2 ; and more than 9kg if previous BMI above 30 kg/m 2 )
3 secondary outcomes
Preterm delivery
Time frame: Diagnosed after delivery
Low Birth weight
Time frame: Data available at one point, after delivery
Pre eclampsia
Time frame: After diagnosis until delivery, up to 20 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 2 Jul 2026.
- Individual participant dataSharing planned: Undecided. and all data were collected by healthcare professionals and processed anonymously to ensure participant confidentiality.
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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.
Filipa M Coutinho, MD principal investigator
Unidade Local de Saúde de Coimbra, EPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity plan and Women who received information but did not engaged in a physical activity routine in people with Hypertension ,Pregnancy and Diabetes During Pregnancy, run by Unidade Local de Saúde de Coimbra, EPE at 1 site in Portugal.
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 7 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 2 Jul 2026. 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 Portugal. 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. Some participants in this study may receive a placebo. 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?
Controlled chronic hypertension (time frame: From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.). 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 2 Jul 2026.