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

NCT07394803 | Not Yet Recruiting

• 1 other identifier: PR(AMI)508/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Pregnancy

Keywords

physical activity during pregnancy; social risk; mental health; moderate physical activity; Facilities and barriers for physical activity in pregnant women

Outcome Measures

Primary Outcomes (5)

• 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

  "Baseline"

• 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

  "Baseline"

• 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

  "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)

  "through study completion, an average of 1 year"

• 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.

  "through study completion, an average of 1 year"

Secondary Outcomes (16)

• Well-being

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

• Lumbar and pelvic pain

  1 year

• maternal weight gain during pregnancy

  from enrollment to 1 month postpartum

• Depression symptoms

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

• Anxiety symptoms

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

Study Arms (1)

Pregnant individuals participating in the moderate physical activity program

EXPERIMENTAL

The 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.

Behavioral: Moderate physical activity

Interventions

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.

Pregnant individuals participating in the moderate physical activity program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: collaborator
• Universidad Politecnica de Madrid: collaborator

Study Sites (2)

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

Barcelona, Spain

Location

Hospital Vall d´Hebron, Barcelona

Barcelona, Spain

Location

Related Publications (5)

• 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.

  PMID: 32168209 BACKGROUND

• 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.

  PMID: 30337460 BACKGROUND

• 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.

  PMID: 30337463 BACKGROUND

• 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.

  PMID: 23045469 BACKGROUND

• 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.

  PMID: 22325300 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Ruben Barakat, PhD

  Universidad Politécnica de Madrid, Spain

  STUDY DIRECTOR

Central Study Contacts

Maia Brik, PhD

CONTACT

0034-934893000; maia.brik@vallhebron.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized multicenter feasibility trial will be performed piloting several components of the trial.

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

ES (2)