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NCT Number: NCT07394803

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

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

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Key information

Conditions

Pregnancy Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centros de Atenció a la salut sexual i reproductiva (ASSIR) in Barcelona Nord, Barcelona, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moderate Physical Activity

Behavioral

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.

Primary outcomes

  1. Acceptability

    Time frame: "Baseline"

    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

  2. Rejection to participate in the physical activity program

    Time frame: "Baseline"

    Number of individuals that reject to participate in the study at "baseline" after explaining the study procedure and signed rejection CI

  3. Reasons for rejection

    Time frame: "Baseline"

    • 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

  4. Perceived barriers for performing physical activity during pregnancy

    Time frame: "through study completion, an average of 1 year"

    A Likert Scale questionnaire self-created will be assessed by each participant (23 items will be assessed)

  5. Adherence to the program

    Time frame: "through study completion, an average of 1 year"

    Registration of the attendance to the on-site PA classes will be mandatory, and also in the online (via Zoom), it will be assesed.

Secondary outcomes

  1. Well-being

    Time frame: At enrollment, end of pregnancy and 4-6 weeks postpartum

    Using the WHO-5 questionnaire. Raw scores ranging from 0 (minimum, worst imaginable well-being) to 25 (maximum, best imaginable well-being)

  2. Lumbar and pelvic pain

    Time frame: 1 year

    Lumbar and pelvic pain through the pregnancy will be assessed during pregnancy medical records yes/no

  3. maternal weight gain during pregnancy

    Time frame: from enrollment to 1 month postpartum

    Maternal weight gain in Kg during antenatal care

  4. Depression symptoms

    Time frame: At enrollment, end of pregnancy and at 4-6 weeks postpartum

    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

  5. Anxiety symptoms

    Time frame: At enrollment, end of pregnancy and at 4-6 weeks postpartum

    STAI questionnaire ( trait-state). Consists of two 20-item subscales (State and Trait), each with a minimum score of 20 and a maximum score of 80. Higher scores indicate greater anxiety levels

  6. Stress

    Time frame: At enrollment, end of pregnancy and at 4-6 weeks postpartum

    PSS questionnaire. The Perceived Stress Scale (PSS-10) ranges from 0 to 40, with 0 being the minimum (no stress) and 40 being the maximum (very high stress)

  7. Health Related Quality of Life

    Time frame: At enrollment, end of pregnancy and at 4-6 weeks postpartum

    SF 12 questionnaire. The SF-12 health survey uses norm-based scoring, resulting in Physical (PCS) and Mental (MCS) Component Summary scores with a mean of 50 and a standard deviation of 10 in the general population. Scores generally range from approximately 0 to 100, where higher values indicate better health

  8. Quality of Sleep

    Time frame: At enrollment, end of pregnancy and at 4-6 weeks postpartum

    Pittsburgh Sleep Questionnaire ( PSQI). The Pittsburgh Sleep Quality Index (PSQI) total global score ranges from a minimum of 0 to a maximum of 21. A lower score (0-5) indicates better sleep quality, while a higher score (>5) indicates poorer sleep quality

  9. Social Support

    Time frame: At enrollment, end of pregnancy and at 4-6 weeks postpartum

    MOSSS questionnaire. The MOS Social Support Survey (MOS-SSS) typically uses 19 items rated on a 5-point Likert scale (1=None of the time to 5=All of the time), resulting in a minimum raw score of 19 and a maximum of 95. These scores are commonly transformed to a 0-100 scale, where 0 represents the lowest and 100 the highest possible social support

  10. Physical Activity

    Time frame: At enrollment, end of pregnancy and at 4-6 weeks postpartum

    IPAQ questionnaire. The International Physical Activity Questionnaire (IPAQ) measures activity in MET-minutes/week, with categorizations for low (<600), moderate (600-3000), and high (>3000) levels. Data is cleaned by truncating daily activity to 180 minutes and requires activities to last at least 10 minutes. The minimum is 0, while high-level, vigorous activity can exceed 3000+ MET-min/week

  11. Pregnancy complications: preterm birth

    Time frame: birth

    Gestational age at birth below 37 w

  12. Pregnancy Complications: Gestational diabetes

    Time frame: during pregnancy, , both between 24-28 weeks

    Gestational diabetes, as 100 mg Glucose Tolerance Test positive or HbA1c> 5.7%

  13. Birth Outcomes: Birth weight

    Time frame: 1 month

    Birth weight in Kg

  14. Birth Outcomes: NICU admission

    Time frame: 1 month

    NICU Admission yes/no

  15. Birth Outcomes

    Time frame: 1 month

    Apgar Score at birth 1/5/10 minutes

  16. Pregnancy Complications: Pregnancy Induced Hypertension

    Time frame: during pregnancy and at birth

    Preeclampsia, Gestational Hypertension, Eclampsia and/or Placental Insuficiency ( IUGR)

Study contacts

Contact information is provided by the study sponsor or research team.

Maia Brik, PhD

CONTACT

[email protected]

0034-934893000 ext. 3085

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
  • Universidad Politecnica de Madrid

Registry information

Acronym: ACTIVA

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 6, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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