Diabetes During Pregnancy, Hypertension ,Pregnancy, Obesity (BMI>30)
Conditions
Keywords
Gestational Diabetes, Chronic hypertension, Obesity, Prenatal exercise, Smartwatch monitoring, Digital health, High-risk pregnancy, Physical activity intervention
Brief 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. 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.
Interventions
BEHAVIORALPhysical activity plan
pregnant women who engaged in a physical activity routine previously prescribed
BEHAVIORALWomen who received information but did not engaged in a physical activity routine
No structured physical activity
Sponsors
Unidade Local de Saúde de Coimbra, EPE
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Controlled chronic hypertension | 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 | 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 | 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 ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preterm delivery | Diagnosed after delivery | Preterm birth was considered if deliver occurred before 37 weeks of gestational age |
| Low Birth weight | Data available at one point, after delivery | Low birth weight was defined as a birth weight of less than 2500g. |
| Pre eclampsia | After diagnosis until delivery, up to 20 weeks. | 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. |
Countries
Portugal
Contacts
PRINCIPAL_INVESTIGATORFilipa M Coutinho, MD
Unidade Local de Saúde de Coimbra, EPE
Outcome results
None listed