An interventional study of Physical activity plan and Women who received information but did not engaged in a physical activity routine in Hypertension ,Pregnancy, Diabetes During Pregnancy and Obesity (BMI>30), sponsored by Unidade Local de Saúde de Coimbra, EPE. Completed at 1 site in Portugal. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Unidade Local de Saúde de Coimbra, EPE · Not applicable, Interventional, and Prevention
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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).
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.
262 studies on the registry are indexed under Hypertension, Pregnancy-Induced; 71 are open to participants now.
This study's enrollment of 310 is above the median of 147 across 174 interventional studies indexed under Hypertension, Pregnancy-Induced.
Browse Hypertension, Pregnancy-Induced studies →Unidade Local de Saúde de Coimbra, EPE is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Physical activity plan
Pregnant women who despite the active recommendation did not adhere to the prescribed physical activity plan
Behavioral: Women who received information but did not engaged in a physical activity routine
pregnant women who engaged in a physical activity routine previously prescribed
No structured physical activity
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
Time frame: 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.
Time frame: 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 )
Time frame: From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.
Preterm delivery
Preterm birth was considered if deliver occurred before 37 weeks of gestational age
Time frame: Diagnosed after delivery
Low Birth weight
Low birth weight was defined as a birth weight of less than 2500g.
Time frame: 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.
Time frame: After diagnosis until delivery, up to 20 weeks.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — and all data were collected by healthcare professionals and processed anonymously to ensure participant confidentiality.
Ran from Feb 2024 to primary completion in Feb 2025, 12 months.
Of 90 non-industry interventional studies with no phase under Hypertension, Pregnancy-Induced, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's 12 months is below that.
Counting every sponsor, half of 91 studies reached it within 23 months; a quarter within 10 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Hypertension, Pregnancy-Induced →
Unidade Local de Saúde de Coimbra, EPE