Remotely Monitored Exercise Program in Pregnant Women With Obesity

Pregnancy Related Clinical Trial

— GROB  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05331586
• Other study ID #: 0000
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: May 2023

Study information

• Verified date: February 2022
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gestational Weight Gain
• Obesity
• Pregnancy Related

Intervention

Behavioral:
• Remote 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

Locations

Country	Name	City	State
Portugal	Diana Bernardo	Porto

Sponsors (2)

Lead Sponsor	Collaborator
Universidade do Porto	Fundação para a Ciência e a Tecnologia

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Low Back Pain	Oswestry Low Back Pain Disability Questionnaire (ODI v2.0)	At first, second and third gestational trimester
Secondary	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
Secondary	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
Secondary	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
Secondary	Quality of Life Assessment	COOP-Quality of life during Pregnancy Questionnaire	At first, second and third gestational trimester
Secondary	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