NCT07394803 Physical Activity and Pregnant Women at Increased Social Risk: a Feasibility Study
| NCT ID | NCT07394803 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute |
| Condition | Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-02-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Objective: To test the feasibility of the implementation of a moderate intensity physical activity program during pregnancy in a group of pregnant women at social risk. Methods: a non-randomized feasibility study piloting several components of the trial Inclusion criteria: \> 18 yo, antenatal care at HVH and/or ASSIR SAP Muntanya, and vulnerable socioeconomical conditions. Exclusion criteria: contraindications for the practice of physical activity during pregnancy according to Spanish and Canadian Guidelines. Practical Course of the research: Women will be recruited for the study and will perform a physical activity moderate intensity hybrid (on-site and online) program during pregnancy (3 times per week 60 min sessions) and will respond to several questionnaires (Barriers, IPAQ, WHO-5, EPDS, STAI, SF-12, MOSSS, PSQI) Those who reject to participate in the program, will be offered to respond to these questionnaires. Main outcomes are the acceptability to the program, the reasons for rejection, the physical activity level during pregnancy, the barriers and facilitators to physical activity during pregnancy. Number of recruiting centers: Hospital Vall d´Hebron and Primary Care Center ASSIR Muntanya (Centro de atención a la salud sexual y Reproductiva) Barcelona Nord. Sample size: 60 aiming to achieve 30 women in the physical activity program Statistical analyses: quantitative descriptive analysis. Source of funding: no funding available, pending for funding
Eligibility Criteria
Inclusion Criteria: * Maternal age above 18 years old. * Antenatal care at ASSIR Barcelona Nord (SAP Muntanya), and/or Hospital Vall d´Hebron. * Fulfilling social risk criteria defined by the Local Protocol (13), that includes as vulnerable socioeconomical conditions: low economic income, unemployed, poor nutrition, low educational level, difficult access to perinatal healthcare and lack of social and familiar support. Exclusion Criteria: * Contraindications for the practice of physical activity during pregnancy according to the Spanish and/or Canadian (5,6,14)guidelines of physical activity during pregnancy (ref). * Unable to communicate in the official language (Spanish or Catalan) * Aiming to give birth in a different setting of the study setting.
Contact & Investigator
Ruben Barakat, PhD
STUDY DIRECTOR
Universidad Politécnica de Madrid, Spain
Frequently Asked Questions
Who can join the NCT07394803 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07394803 currently recruiting?
Yes, NCT07394803 is actively recruiting participants. Contact the research team at maia.brik@vallhebron.cat for enrollment information.
Where is the NCT07394803 trial being conducted?
This trial is being conducted at Barcelona, Spain, Barcelona, Spain.
Who is sponsoring the NCT07394803 clinical trial?
NCT07394803 is sponsored by Hospital Universitari Vall d'Hebron Research Institute. The principal investigator is Ruben Barakat, PhD at Universidad Politécnica de Madrid, Spain. The trial plans to enroll 60 participants.