Remotely Monitored and Exercise Program in Gestational Weight Gain in Pregnant Women With Obesity
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Excessive gestational weight gain
研究概览
简要总结
Pregnant women with obesity will be invited to participate in structured home-based exercise programme, remotely monitored
详细描述
Pregnant women with obesity will be invited to participate in structured home-based exercise programme, remotely monitored. The remote system use inertial motion trackers, digitizes pregnant women motion and provides real-time feedback on performance through a mobile app. It also includes a web-based platform that allows the clinical team to prescribe, monitor and adapt the exercise program remotely. This way, the system allows patients to perform independent exercise program at home without the need for constant therapist supervision, ensuring remote monitoring throughout the rehabilitation program. The exercise programme will be performed since the first gestational trimester until delivery.
Data of gestational weight gain, gestational diabetes mellitus, low back pain and quality of life will be colected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with obesity (BMI ≥ 30 kg/m2) at first gestational trimester
排除标准
- •pre-pregnancy BMI < 30 kg/m2;
- •previous bariatric surgery;
- •hemodynamically significant heart disease;
- •restrictive lung disease;
- •incompetent cervix or cerclage;
- •multiple gestation;
- •persistent second- or third-trimester bleeding;
- •placenta previa after 26 weeks of gestation;
- •premature labor during the current pregnancy;
- •ruptured membranes;
- •preeclampsia or pregnancy-induced hypertension;
- •severe anemia;
- •inability to read and understand Portuguese; ->15 weeks gestation.
研究组 & 干预措施
control intervention
The control group will receive the standard prenatal care in Hospital Center of São Joao (CHUSJ). The standard prenatal care will be regular appointments with obstetrician and midwife nurses, ultrasounds and nutritional appointments. The pregnant women in control group will also receive a pamphlet with the benefits of physical exercise during pregnancy and recommendations for adequate gestational weight gain. Pregnant women in control group will not be discouraged from exercising on their own.
Exercise intervention
The exercise group intervention will perform home-based remotely monitored exercise
干预措施: Remote Exercise (Behavioral)
结局指标
主要结局
Excessive gestational weight gain
时间窗: At delivery
The adequate gestational weight gain in pregnant women with obesity should not exceed 9kg in entire pregnancy, the values over these thresholds will be considered excessive gestational weight gain.
Gestational Weight Gain
时间窗: At delivery
Using portable digital scale (Tantita InnerScan BC-545). Gestational weight gain will be calculated as the difference between maternal weight at last appointment (36-39 gestational weeks) and pre-pregnancy weight.
次要结局
- Quality of Life Assessment(At first, second and third gestational trimester)
- Subjective Physical Activity assessment(At first, second and third gestational trimester)
- Pelvic Floor and sexual disorders during pregnancy(At first, second and third gestational trimester)
- Low Back Pain(At first, second and third gestational trimester)
- Objective Physical Activity assessment(At first, second and third gestational trimester)
- Gestational Diabetes Mellitus(Second gestational trimester)