Remotely Monitored Exercise Program in Pregnant Women With Obesity (GROB)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related; Obesity, Maternal
• Intervention / Treatment: Behavioral: Remote Exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal
    • Diana Bernardo
    • Contact: Diana Bernardo; Phone Number: 936599998; Email: ftdianabernardo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: Exercise intervention; The exercise group intervention will perform home-based remotely monitored exercise	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: Fundação para a Ciência e a Tecnologia

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; Obesity; exercise; pregnancy; gestational diabetes mellitus; gestational weight gain; maternal
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Pregnancy Complications; Body Weight Changes; Weight Gain; Obesity; Obesity, Maternal; Gestational Weight Gain
• Other Study ID Numbers: 0000 (Centre for care Science, KI, Norrbacka Eugeniastiftelsen)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No