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
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.
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.
Single group
Moderate physical activity
BehavioralThe 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.
Acceptability
Number of individuals that agrees to participate in the study at "baseline", after offering the study participations and explaining the study procedure, and sign the informed consent document
Rejection to participate in the physical activity program
Number of individuals that reject to participate in the study at "baseline" after explaining the study procedure and signed rejection CI
Reasons for rejection
\- Reason for rejection to participate in the study: lack of time, cultural, stigma related mental health or physical activity, hesitance regarding participation on a trial, others... when offering the study participation at baseline
Perceived barriers for performing physical activity during pregnancy
A Likert Scale questionnaire self-created will be assessed by each participant (23 items will be assessed)
Well-being
Using the WHO-5 questionnaire. Raw scores ranging from 0 (minimum, worst imaginable well-being) to 25 (maximum, best imaginable well-being)
Lumbar and pelvic pain
Lumbar and pelvic pain through the pregnancy will be assessed during pregnancy medical records yes/no
maternal weight gain during pregnancy
Maternal weight gain in Kg during antenatal care
Depression symptoms
EPDS questionnaire, ranges from a total score of 0 and a maximum total score of 30. Each item is scored from 0 to 3, with higher scores indicating more severe depressive symptoms
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Hospital Universitari Vall d'Hebron Research Institute
Lead sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborator
Universidad Politecnica de Madrid
Collaborator
