RecruitingNot ApplicableNCT07394803

Physical Activity and Pregnant Women at Increased Social Risk: a Feasibility Study

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Enrollment

60 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Pregnancy

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Moderate physical activity for people with pregnancy. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALModerate physical activity

The intervention program will follow a physical exercise program supported by the Canadian and Spanish Guidelines, for exercise throughout pregnancy and published by Barakat model, supporting a minimum of 150 minutes per week of moderate intensity exercise. It consists on three weekly sessions of 60 min, following a hybrid program (on-site and online via Zoom®). The on-site sessions will be held at CAP San Andreu in a gym room. Once a week, the Borg Scale of Perceived Effort is administered to have a more reliable assessment of the intensity of the activities, 12-14 (moderate; out of a 20-point scale) is the level used. The minimum adherence required for the participants will be 70% of the total sessions, but no restriction will be taken to the classes, adherence will be recorded. Women accepting participation, with no contraindications to perform physical activity, will sign the consent form- Implementation of the PA Program crossingbox that includes the physical activity program.