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

Primary Purpose

Pregnancy Related, Obesity, Maternal

Status
Not yet recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Remote Exercise
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy Related focused on measuring Obesity, pregnancy, exercise, physical activity, maternal, gestational weight gain, gestational diabetes mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Diana Bernardo

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control intervention

Exercise intervention

Arm Description

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.

The exercise group intervention will perform home-based remotely monitored exercise

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Low Back Pain
Oswestry Low Back Pain Disability Questionnaire (ODI v2.0)
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.
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)
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.
Quality of Life Assessment
COOP-Quality of life during Pregnancy Questionnaire
Pelvic Floor and sexual disorders during pregnancy
Assessment of Pelvic Floor Disorders and Their Risk Factors During Pregnancy and Postpartum Questionnaire

Full Information

First Posted
March 3, 2022
Last Updated
June 20, 2022
Sponsor
Universidade do Porto
Collaborators
Fundação para a Ciência e a Tecnologia
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1. Study Identification

Unique Protocol Identification Number
NCT05331586
Brief Title
Remotely Monitored Exercise Program in Pregnant Women With Obesity
Acronym
GROB
Official Title
Remotely Monitored and Exercise Program in Gestational Weight Gain in Pregnant Women With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Porto
Collaborators
Fundação para a Ciência e a Tecnologia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Obesity, Maternal
Keywords
Obesity, pregnancy, exercise, physical activity, maternal, gestational weight gain, gestational diabetes mellitus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control intervention
Arm Type
No Intervention
Arm Description
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.
Arm Title
Exercise intervention
Arm Type
Experimental
Arm Description
The exercise group intervention will perform home-based remotely monitored exercise
Intervention Type
Behavioral
Intervention Name(s)
Remote Exercise
Intervention Description
The pregnant women will perform a home-based structured exercise programme. The exercise will be remotely monitored since the first gestational trimester until delivery
Primary Outcome Measure Information:
Title
Gestational Weight Gain
Description
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.
Time Frame
At delivery
Title
Excessive gestational weight gain
Description
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.
Time Frame
At delivery
Secondary Outcome Measure Information:
Title
Low Back Pain
Description
Oswestry Low Back Pain Disability Questionnaire (ODI v2.0)
Time Frame
At first, second and third gestational trimester
Title
Subjective Physical Activity assessment
Description
Pregnancy Physical Activity Questionnaire (PPAQ) is a self-reported questionnaire. The objective is measure the type and intensity of pregnant women physical activity.
Time Frame
At first, second and third gestational trimester
Title
Objective Physical Activity assessment
Description
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)
Time Frame
At first, second and third gestational trimester
Title
Gestational Diabetes Mellitus
Description
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.
Time Frame
Second gestational trimester
Title
Quality of Life Assessment
Description
COOP-Quality of life during Pregnancy Questionnaire
Time Frame
At first, second and third gestational trimester
Title
Pelvic Floor and sexual disorders during pregnancy
Description
Assessment of Pelvic Floor Disorders and Their Risk Factors During Pregnancy and Postpartum Questionnaire
Time Frame
At first, second and third gestational trimester

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Diana Bernardo
City
Porto
Country
Portugal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Bernardo
Phone
936599998
Email
ftdianabernardo@gmail.com

12. IPD Sharing Statement

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Remotely Monitored Exercise Program in Pregnant Women With Obesity

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