Pregnancy RelatedGROBNCT05331586
Remotely Monitored Exercise Program in Pregnant Women With Obesity
A study testing Remote Exercise in people with Pregnancy Related and Obesity, Maternal, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Pregnant women with obesity will be invited to participate in structured home-based exercise programme, remotely monitored Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Obesity, Maternal
- What is being tested?
- Remote Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- Jul 2022to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women with obesity (BMI ≥ 30 kg/m2) at first gestational trimester
Who cannot join
- pre-pregnancy BMI < 30 kg/m2;
- previous bariatric surgery;
- hemodynamically significant heart disease;
- restrictive lung disease;
- incompetent cervix or cerclage;
- multiple gestation;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Diana Bernardo
Porto
Diana Bernardo, 936599998, ftdianabernardo@gmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- Pregnancy Related, Obesity, Maternal
- Being tested
- Remote Exercise
- Keywords
- Obesity, pregnancy, exercise, physical activity, maternal, gestational weight gain, gestational diabetes mellitus
- Medical subject headings
- Pregnancy in Obesity, Obesity, Motor Activity, Gestational Weight Gain, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ExerciseBehavioural
The pregnant women will perform a home-based structured exercise programme. The exercise will be remotely monitored since the first gestational trimester until delivery
| Study group | Role | What they receive |
|---|---|---|
| control intervention | No 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. |
| Exercise intervention | Experimental | The exercise group intervention will perform home-based remotely monitored exercise Receives: Behavioral: Remote Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At delivery
Secondary outcomes (6)
Low Back Pain
Oswestry Low Back Pain Disability Questionnaire (ODI v2.0)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Second gestational trimester
Quality of Life Assessment
COOP-Quality of life during Pregnancy Questionnaire
Measured: 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
Measured: At first, second and third gestational trimester
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study startJul 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331586
- Sponsor's protocol ID
- 0000
- Acronym
- GROB
- Status last verified
- Feb 2022
- First submitted
- 3 Mar 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Monitored and Exercise Program in Gestational Weight Gain in Pregnant Women With Obesity
- ClinicalTrials.gov ID
- NCT05331586
- Acronym / sponsor ID
- GROB / 0000
- Conditions
- Pregnancy Related, Obesity, Maternal
- Keywords
- Obesity, pregnancy, exercise, physical activity, maternal, gestational weight gain, gestational diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- Jul 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control intervention | No 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. |
| Exercise intervention | Experimental | Behavioral: Remote ExerciseThe exercise group intervention will perform home-based remotely monitored exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women with obesity (BMI ≥ 30 kg/m2) at first gestational trimester
Key exclusion criteria (13 listed)
- pre-pregnancy BMI < 30 kg/m2;
- previous bariatric surgery;
- hemodynamically significant heart disease;
- restrictive lung disease;
- incompetent cervix or cerclage;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ExerciseThe pregnant women will perform a home-based structured exercise programme. The exercise will be remotely monitored since the first gestational trimester until delivery | Behavioural | Exercise intervention |
Primary outcome
Gestational Weight Gain
Time frame: 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
Time frame: 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.
6 secondary outcomes
Low Back Pain
Time frame: At first, second and third gestational trimester
Subjective Physical Activity assessment
Time frame: At first, second and third gestational trimester
Objective Physical Activity assessment
Time frame: At first, second and third gestational trimester
Gestational Diabetes Mellitus
Time frame: Second gestational trimester
Quality of Life Assessment
Time frame: At first, second and third gestational trimester
Pelvic Floor and sexual disorders during pregnancy
Time frame: At first, second and third gestational trimester
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Exercise in people with Pregnancy Related and Obesity, Maternal, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational Weight Gain (time frame: At delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.