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

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

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

Interventions

• Behavioral Moderate physical activity
  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

Primary outcome measures

• Acceptability [Time frame: "Baseline"]
• Rejection to participate in the physical activity program [Time frame: "Baseline"]
• Reasons for rejection [Time frame: "Baseline"]
• Perceived barriers for performing physical activity during pregnancy [Time frame: "through study completion, an average of 1 year"]
• Adherence to the program [Time frame: "through study completion, an average of 1 year"]

Secondary outcome measures (12)

• Well-being [Time frame: At enrollment, end of pregnancy and 4-6 weeks postpartum]
• Lumbar and pelvic pain [Time frame: 1 year]
• maternal weight gain during pregnancy [Time frame: from enrollment to 1 month postpartum]
• Depression symptoms [Time frame: At enrollment, end of pregnancy and at 4-6 weeks postpartum]
• Anxiety symptoms [Time frame: At enrollment, end of pregnancy and at 4-6 weeks postpartum]
• Stress [Time frame: At enrollment, end of pregnancy and at 4-6 weeks postpartum]
• Health Related Quality of Life [Time frame: At enrollment, end of pregnancy and at 4-6 weeks postpartum]
• Quality of Sleep [Time frame: At enrollment, end of pregnancy and at 4-6 weeks postpartum]
• Social Support [Time frame: At enrollment, end of pregnancy and at 4-6 weeks postpartum]
• Physical Activity [Time frame: At enrollment, end of pregnancy and at 4-6 weeks postpartum]
• Pregnancy complications: preterm birth [Time frame: birth]
• Pregnancy Complications: Gestational diabetes [Time frame: during pregnancy, , both between 24-28 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Spain · 2 centers

• Centros de Atenció a la salut sexual i reproductiva (ASSIR) in Barcelona Nord — Barcelona
• Hospital Vall d´Hebron, Barcelona — Barcelona

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. PMID 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. PMID 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 PMID 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. PMID 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. PMID 22325300

Identifiers

NCT: NCT07394803 · PR(AMI)508/2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗