Clinical trial NCT05331586: Remotely Monitored Exercise Program in Pregnant Women With Obesity
Official title: Remotely Monitored and Exercise Program in Gestational Weight Gain in Pregnant Women With Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Related
Obesity, Maternal
Keywords: Obesity
pregnancy
exercise
physical activity
maternal
gestational weight gain
gestational diabetes mellitus
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
First posted: 2022-04-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pregnant women with obesity will be invited to participate in structured home-based exercise programme, remotely monitored

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with obesity (BMI ≥ 30 kg/m2) at first gestational trimester

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Gestational Weight Gain
timeFrame: At delivery
measure: Excessive gestational weight gain
timeFrame: At delivery
Secondary outcomes:
measure: Low Back Pain
timeFrame: At first, second and third gestational trimester
measure: Subjective Physical Activity assessment
timeFrame: At first, second and third gestational trimester
measure: Objective Physical Activity assessment
timeFrame: At first, second and third gestational trimester
measure: Gestational Diabetes Mellitus
timeFrame: Second gestational trimester
measure: Quality of Life Assessment
timeFrame: At first, second and third gestational trimester
measure: Pelvic Floor and sexual disorders during pregnancy
timeFrame: At first, second and third gestational trimester
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Diana Bernardo
Study officials:
References: