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

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

Recruiting
18 years and older
Female
Phase N/A

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Overview

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

Description

Main 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.

Specific objectives:

  • To evaluate the acceptability of the physical activity program
  • To evaluate barriers, facilitators and attitudes towards physical activity in relationship to the physical activity in this target group of population.
  • To evaluate the level of physical activity achieved by this group of population during pregnancy, as well as the sedentarism.
  • To evaluate the impact on the well-being and mental health of a moderate intensity physical activity program during pregnancy in this target group of population.
  • To evaluate the impact on physical health and perception of quality of life and sleep of a moderate intensity physical activity program during pregnancy in this target group of population.

Methods: a non-randomized feasibility study piloting several components of the trialI.

The inclusion criteria are: \> 18 yo, antenatal care at HVH and/or ASSIR SAP Muntanya, and vulnerable socioeconomical conditions, according to the local antenatal protocol.

The exclusion criteria are the presence of 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), following the Barakat Model.

Pregnant individuals who are not interested and reject to participate will be offered to complete several questionnaires during pregnancy to better understand how active they are during pregnancy and what are the reasons to understand why they are not active, as well as the barriers and facilitators, and the perceptions of physical activity during pregnancy.

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.

Secondary outcomes include:

  • Mental Health outcomes: Wellbeing, Depression, Anxiety, Perceived stress, Health related quality of life (HRQoL), Sleep quality , Social support
  • Physical health outcomes: Lumbar and pelvic pain through the pregnancy, Maternal weight gain during pregnancy and Pregnancy complications (preterm birth, gestational diabetes, pregnancy induced hypertension, low birth weight )
    Questionnaires

Barriers ( self-created), IPAQ, WHO-5, EPDS, STAI, SF-12, MOSSS, PSQI, PSS

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 programStatistical analyses: quantitative descriptive analysis.

Source of funding: no funding available, pending for funding

Eligibility

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.

Study details
    Pregnancy

NCT07394803

Hospital Universitari Vall d'Hebron Research Institute

27 June 2026

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