Remotely Monitored Exercise Program in Pregnant Women With Obesity

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

Detailed Description
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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.

Official Title
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Remotely Monitored and Exercise Program in Gestational Weight Gain in Pregnant Women With Obesity

Conditions
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Pregnancy Related, Obesity, Maternal

Intervention / Treatment
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* Behavioral: Remote Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control intervention<br>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. | |
| Experimental: Exercise intervention<br>The exercise group intervention will perform home-based remotely monitored exercise | Behavioral: Remote Exercise<br>* The pregnant women will perform a home-based structured exercise programme. The exercise will be remotely monitored since the first gestational trimester until delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational Weight Gain | 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. | At delivery | 
| Excessive gestational weight gain | 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. | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Back Pain | Oswestry Low Back Pain Disability Questionnaire (ODI v2.0) | At first, second and third gestational trimester | 
| Subjective Physical Activity assessment | Pregnancy Physical Activity Questionnaire (PPAQ) is a self-reported questionnaire. The objective is measure the type and intensity of pregnant women physical activity. | At first, second and third gestational trimester | 
| Objective Physical Activity assessment | 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) | At first, second and third gestational trimester | 
| Gestational Diabetes Mellitus | 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. | Second gestational trimester | 
| Quality of Life Assessment | COOP-Quality of life during Pregnancy Questionnaire | At first, second and third gestational trimester | 
| Pelvic Floor and sexual disorders during pregnancy | Assessment of Pelvic Floor Disorders and Their Risk Factors During Pregnancy and Postpartum Questionnaire | At first, second and third gestational trimester | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, pregnancy, exercise, physical activity, maternal, gestational weight gain, gestational diabetes mellitus