Obesity, Maternal, Pregnancy Related
Conditions
Keywords
Obesity, pregnancy, exercise, physical activity, maternal, gestational weight gain, gestational diabetes mellitus
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.
Interventions
BEHAVIORALRemote Exercise
The pregnant women will perform a home-based structured exercise programme. The exercise will be remotely monitored since the first gestational trimester until delivery
Sponsors
Fundação para a Ciência e a Tecnologia
Universidade do Porto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational Weight Gain | 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. |
| Excessive gestational weight gain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Physical Activity assessment | At first, second and third gestational trimester | Accelerometry, is a device that monitors the acceleration of body segments, it is considered the gold standard with regard to objectivity and reliability (ICC:0.661-0.806) |
| Gestational Diabetes Mellitus | Second gestational trimester | The presence of gestational diabetes mellitus will be assessed between 24-28 gestation weeks, through the Oral Glucose Tolerance Test. Blood sampling for fasting glucose concentrations will be taken after a 10 hour overnight fast, and glucose tolerance will measured by a 2 hours 75 mg per-oral glucose tolerance test. GDM will be diagnosed as fasting glucose ≥ 126 mg/dl or 2h concentration ≥ 200 mg/dl. |
| Low Back Pain | At first, second and third gestational trimester | Oswestry Low Back Pain Disability Questionnaire (ODI v2.0) |
| Pelvic Floor and sexual disorders during pregnancy | At first, second and third gestational trimester | Assessment of Pelvic Floor Disorders and Their Risk Factors During Pregnancy and Postpartum Questionnaire |
| Quality of Life Assessment | At first, second and third gestational trimester | COOP-Quality of life during Pregnancy Questionnaire |
| Subjective Physical Activity assessment | At first, second and third gestational trimester | Pregnancy Physical Activity Questionnaire (PPAQ) is a self-reported questionnaire. The objective is measure the type and intensity of pregnant women physical activity. |
Countries
Portugal
Outcome results
None listed