Impact of Exercise Prescription on Obstetric and Neonatal Outcomes

NCT07678944 | Completed

• 1 other identifier: ULSCoimbra
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypertension ,Pregnancy; Diabetes During Pregnancy; Obesity (BMI>30)

Keywords

Gestational Diabetes; Chronic hypertension; Obesity; Prenatal exercise; Smartwatch monitoring; Digital health; High-risk pregnancy; Physical activity intervention

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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 )

  From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.

Secondary Outcomes (3)

• Preterm delivery

  Diagnosed after delivery

• Low Birth weight

  Data available at one point, after delivery

• Pre eclampsia

  After diagnosis until delivery, up to 20 weeks.

Study Arms (2)

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.

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

Behavioral: Women who received information but did not engaged in a physical activity routine

Interventions

Physical activity plan BEHAVIORAL

pregnant women who engaged in a physical activity routine previously prescribed

women who adhere to the recommended exercise prescription

Women who received information but did not engaged in a physical activity routine BEHAVIORAL

No structured physical activity

women who did not adhere to the recommended exercise prescription

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unidade Local de Saúde de Coimbra, EPE: lead

Study Sites (1)

ULSCoimbra

Coimbra, Coimbra District, 3004-561, Portugal

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Diabetes, Gestational; Obesity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Filipa M Coutinho, MD

  Unidade Local de Saúde de Coimbra, EPE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Attending Physician, Internal Medicine

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: July 1, 2026
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 2, 2026

Record last verified: 2025-01

Locations

PT (1)