Physical Activity and Pregnant Women at Increased Social Risk: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Acceptability
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Pregnant individuals participating in the moderate physical activity program
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.
干预措施: Moderate physical activity (Behavioral)
结局指标
主要结局
Acceptability
时间窗: "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
Rejection to participate in the physical activity program
时间窗: "Baseline"
Number of individuals that reject to participate in the study at "baseline" after explaining the study procedure and signed rejection CI
Reasons for rejection
时间窗: "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
Perceived barriers for performing physical activity during pregnancy
时间窗: "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)
Adherence to the program
时间窗: "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.
次要结局
- 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)
- Stress(At enrollment, end of pregnancy and at 4-6 weeks postpartum)
- Health Related Quality of Life(At enrollment, end of pregnancy and at 4-6 weeks postpartum)
- Quality of Sleep(At enrollment, end of pregnancy and at 4-6 weeks postpartum)
- Social Support(At enrollment, end of pregnancy and at 4-6 weeks postpartum)
- Physical Activity(At enrollment, end of pregnancy and at 4-6 weeks postpartum)
- Pregnancy complications: preterm birth(birth)
- Pregnancy Complications: Gestational diabetes(during pregnancy, , both between 24-28 weeks)
- Birth Outcomes: Birth weight(1 month)
- Birth Outcomes: NICU admission(1 month)
- Birth Outcomes(1 month)
- Pregnancy Complications: Pregnancy Induced Hypertension(during pregnancy and at birth)