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PregnancyACTIVANCT07394803

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

A study testing Moderate physical activity in people with Pregnancy, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy
What is being tested?
Moderate physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesSpain
Study dates
1 Feb 2026to 1 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Maia Brik, PhD contact

0034-934893000 ext. 3085

maia.brik@vallhebron.cat

Spain2 sites, 2 recruiting

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

    Barcelona

    Marta Calveiro Hermo, 0034-932745516

    Recruiting

  • Hospital Vall d´Hebron, Barcelona

    Barcelona

    Maia Brik, 0034934893000 ext. 3085, maia.brik@vallhebron.cat

    Recruiting

Other trials in Spain

About this 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.

Read more

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

Read the detailed 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

Conditions
Pregnancy
Being tested
Moderate physical activity
Keywords
physical activity during pregnancy, social risk, mental health, moderate physical activity, Facilities and barriers for physical activity in pregnant women
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moderate physical activityBehavioural

    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.

Study groups in NCT07394803
Study groupRoleWhat they receive
Pregnant individuals participating in the moderate physical activity programExperimentalThe design of the physical exercise program is supported by the Canadian and Spanish Guidelines (5,6,14) , for exercise throughout pregnancy and published by Barakat model (15) , supporting a minimum of 150 minutes per week of moderate intensity exercise. The program consists of three weekly sessions. The duration of every session lasts 55-60 minutes. Once a week, the Borg Scale of Perceived Effort is administered to participants, in order 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. The adherence to the program will be recorded. The intervention program will follow Barakat´s Model and consist three weekly sessions of 60 minutes, 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.
Receives: Behavioral: Moderate physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: "Baseline"

  2. 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

    Measured: "Baseline"

  3. 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

    Measured: "Baseline"

  4. 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)

    Measured: "through study completion, an average of 1 year"

  5. Adherence to the program

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

    Measured: "through study completion, an average of 1 year"

Secondary outcomes (16)

  1. Well-being

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

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

  2. Lumbar and pelvic pain

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

    Measured: 1 year

  3. maternal weight gain during pregnancy

    Maternal weight gain in Kg during antenatal care

    Measured: from enrollment to 1 month postpartum

  4. 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

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

  5. Anxiety symptoms

    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

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

  6. Stress

    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)

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

  7. Health Related Quality of Life

    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

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

  8. Quality of Sleep

    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

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

  9. Social Support

    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

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

  10. Physical Activity

    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

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

  11. Pregnancy complications: preterm birth

    Gestational age at birth below 37 w

    Measured: birth

  12. Pregnancy Complications: Gestational diabetes

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

    Measured: during pregnancy, , both between 24-28 weeks

  13. Birth Outcomes: Birth weight

    Birth weight in Kg

    Measured: 1 month

  14. Birth Outcomes: NICU admission

    NICU Admission yes/no

    Measured: 1 month

  15. Birth Outcomes

    Apgar Score at birth 1/5/10 minutes

    Measured: 1 month

  16. Pregnancy Complications: Pregnancy Induced Hypertension

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

    Measured: during pregnancy and at birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study start1 Feb 2026
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Non-randomized multicenter feasibility trial will be performed piloting several components of the trial.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07394803
Sponsor's protocol ID
PR(AMI)508/2024
Acronym
ACTIVA
Status last verified
May 2026
First submitted
14 Jan 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data could be shared upon request, and if ethical committe approves the sharing, and participants consent for the data sharing

Publications

  • Wang E, Glazer KB, Howell EA, Janevic TM. Social Determinants of Pregnancy-Related Mortality and Morbidity in the United States: A Systematic Review. Obstet Gynecol. 2020 Apr;135(4):896-915. doi: 10.1097/AOG.0000000000003762.

    PubMed 32168209

  • Mottola MF, Davenport MH, Ruchat SM, Davies GA, Poitras VJ, Gray CE, Jaramillo Garcia A, Barrowman N, Adamo KB, Duggan M, Barakat R, Chilibeck P, Fleming K, Forte M, Korolnek J, Nagpal T, Slater LG, Stirling D, Zehr L. 2019 Canadian guideline for physical activity throughout pregnancy. Br J Sports Med. 2018 Nov;52(21):1339-1346. doi: 10.1136/bjsports-2018-100056.

    PubMed 30337460

  • Davenport MH, Ruchat SM, Poitras VJ, Jaramillo Garcia A, Gray CE, Barrowman N, Skow RJ, Meah VL, Riske L, Sobierajski F, James M, Kathol AJ, Nuspl M, Marchand AA, Nagpal TS, Slater LG, Weeks A, Adamo KB, Davies GA, Barakat R, Mottola MF. Prenatal exercise for the prevention of gestational diabetes mellitus and hypertensive disorders of pregnancy: a systematic review and meta-analysis. Br J Sports Med. 2018 Nov;52(21):1367-1375. doi: 10.1136/bjsports-2018-099355.

    PubMed 30337463

  • Genest DS, Falcao S, Gutkowska J, Lavoie JL. Impact of exercise training on preeclampsia: potential preventive mechanisms. Hypertension. 2012 Nov;60(5):1104-9. doi: 10.1161/HYPERTENSIONAHA.112.194050. Epub 2012 Oct 8.

    PubMed 23045469

  • Ferraro ZM, Gaudet L, Adamo KB. The potential impact of physical activity during pregnancy on maternal and neonatal outcomes. Obstet Gynecol Surv. 2012 Feb;67(2):99-110. doi: 10.1097/OGX.0b013e318242030e.

    PubMed 22325300

Questions about this trial

What is this clinical trial studying?

A study testing Moderate physical activity in people with Pregnancy, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maia Brik, PhD (0034-934893000 ext. 3085, maia.brik@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability (time frame: "Baseline"). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07394803, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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