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| Name | Class |
|---|---|
| Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina | OTHER |
| Universidad Politecnica de Madrid | OTHER |
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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
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:
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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" |
| Measure | Description | Time Frame |
|---|---|---|
| Well-being | Using the WHO-5 questionnaire. Raw scores ranging from 0 (minimum, worst imaginable well-being) to 25 (maximum, best imaginable well-being) | At enrollment, end of pregnancy and 4-6 weeks postpartum |
| Lumbar and pelvic pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maia Brik, PhD | Contact | 0034-934893000 | 3085 | maia.brik@vallhebron.cat |
| Name | Affiliation | Role |
|---|---|---|
| Ruben Barakat, PhD | Universidad Politécnica de Madrid, Spain | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centros de Atenció a la salut sexual i reproductiva (ASSIR) in Barcelona Nord | Recruiting | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32168209 | Background | 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. | |
| 30337460 | 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. |
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Data could be shared upon request, and if ethical committe approves the sharing, and participants consent for the data sharing
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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Non-randomized multicenter feasibility trial will be performed piloting several components of the trial.
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Lumbar and pelvic pain through the pregnancy will be assessed during pregnancy medical records yes/no
| 1 year |
| maternal weight gain during pregnancy | Maternal weight gain in Kg during antenatal care | from enrollment to 1 month postpartum |
| 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 | At enrollment, end of pregnancy and at 4-6 weeks postpartum |
| 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 | At enrollment, end of pregnancy and at 4-6 weeks postpartum |
| 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) | At enrollment, end of pregnancy and at 4-6 weeks postpartum |
| 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 | At enrollment, end of pregnancy and at 4-6 weeks postpartum |
| 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 | At enrollment, end of pregnancy and at 4-6 weeks postpartum |
| 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 | At enrollment, end of pregnancy and at 4-6 weeks postpartum |
| 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 | At enrollment, end of pregnancy and at 4-6 weeks postpartum |
| Pregnancy complications: preterm birth | Gestational age at birth below 37 w | birth |
| Pregnancy Complications: Gestational diabetes | Gestational diabetes, as 100 mg Glucose Tolerance Test positive or HbA1c> 5.7% | during pregnancy, , both between 24-28 weeks |
| Birth Outcomes: Birth weight | Birth weight in Kg | 1 month |
| Birth Outcomes: NICU admission | NICU Admission yes/no | 1 month |
| Birth Outcomes | Apgar Score at birth 1/5/10 minutes | 1 month |
| Pregnancy Complications: Pregnancy Induced Hypertension | Preeclampsia, Gestational Hypertension, Eclampsia and/or Placental Insuficiency ( IUGR) | during pregnancy and at birth |
| Hospital Vall d´Hebron, Barcelona | Recruiting | Barcelona | Spain |
|
| 30337463 | 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. |
| 23045469 | 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. |
| 22325300 | 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. |