ObesityNCT02180152
Postprandial Walking in Obese Pregnant Women and Perinatal Outcomes - a Multicenter Randomized Clinical Trial
A study testing Postprandial walks in people with Obesity and Gestational Diabetes, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.
Trial summary
The purpose of this study is to verify if postprandial walks are effective in obese pregnant women, as regards to gestational weight gain and typical diseases of that period, as gestational diabetes and preeclampsia. Perinatal outcomes will be observed, such as macrosomia, shoulder dystocia and fetal death. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Obesity, Gestational Diabetes, Preeclampsia
- What is being tested?
- Postprandial walks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Mar 2016
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 40 years;
- Gestational age ≤ 20 weeks, calculated from the last menstrual period and confirmed by the first ultrasound scan;
- Obesity - body mass index ( BMI ) ≥ 30 kg/m2, based on the weight before pregnancy, reported by pregnant women no more than 5 kg below measured at admission to the study;
- Physically inactive - according to the International Physical Activity Questionnaire (IPAC);
- Single pregnancy.
Who cannot join
- Kidney disease or collagen;
- Previous history of GDM;
- Diabetes type 1 or type 2;
- Hypertensive disorders related to pregnancy;
- Hemodynamic instability;
- Vaginal bleeding;
- Visual, auditory or cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, 50070-550
About this study
The purpose of this study is to verify if postprandial walks are effective in obese pregnant women, as regards to gestational weight gain and typical diseases of that period, as gestational diabetes and preeclampsia. Perinatal outcomes will be observed, such as macrosomia, shoulder dystocia and fetal death.
- Conditions
- Obesity, Gestational Diabetes, Preeclampsia
- Being tested
- Postprandial walks
- Keywords
- Perinatal outcomes
- Medical subject headings
- Obesity, Diabetes, Gestational, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postprandial walksBehavioural
Obese pregnant women will be target to carry out walks lasting 10' after the main meals (breakfast, lunch and dinner), Monday to Friday, during 8 weeks. Adherence to the program will be determined by daily readings of pedometers previously provided to pregnant women; minimum of 1500 steps per day from Monday to Friday.
| Study group | Role | What they receive |
|---|---|---|
| Postprandial walk | Experimental | Not described Receives: Behavioral: Postprandial walks |
| sedentary pregnant women | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain after postprandial walks in obese pregnant women.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João Guilherme Bezerra Alves, Professor Fernando Figueira Integral Medicine Institute
- Investigators
- Joao GB Alves, PhD, Study director, Instituto de Medicina Integral Professor Fernando FigueiraIsabelle EA Pontes, Master, Principal investigator, Instituto de Medicina Integral Prof. Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180152
- Sponsor's protocol ID
- Caminhadas2014
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2014
- Last updated
- 23 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Walking in Obese Pregnant Women and Perinatal Outcomes - a Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02180152
- Acronym / sponsor ID
- Caminhadas2014
- Conditions
- Obesity, Gestational Diabetes, Preeclampsia
- Keywords
- Perinatal outcomes
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Professor Fernando Figueira Integral Medicine InstituteUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Jul 2014 (estimated)
- 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.
The purpose of this study is to verify if postprandial walks are effective in obese pregnant women, as regards to gestational weight gain and typical diseases of that period, as gestational diabetes and preeclampsia. Perinatal outcomes will be observed, such as macrosomia, shoulder dystocia and fetal death.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postprandial walk | Experimental | Behavioral: Postprandial walks |
| sedentary pregnant women | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 40 years;
- Gestational age ≤ 20 weeks, calculated from the last menstrual period and confirmed by the first ultrasound scan;
- Obesity - body mass index ( BMI ) ≥ 30 kg/m2, based on the weight before pregnancy, reported by pregnant women no more than 5 kg below measured at admission to the study;
- Physically inactive - according to the International Physical Activity Questionnaire (IPAC);
- Single pregnancy.
Key exclusion criteria (7 listed)
- Kidney disease or collagen;
- Previous history of GDM;
- Diabetes type 1 or type 2;
- Hypertensive disorders related to pregnancy;
- Hemodynamic instability;
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 |
|---|---|---|
| Postprandial walksObese pregnant women will be target to carry out walks lasting 10' after the main meals (breakfast, lunch and dinner), Monday to Friday, during 8 weeks. Adherence to the program will be determined by daily readings of pedometers previously provided to pregnant women; minimum of 1500 steps per day from Monday to Friday. | Behavioural | Postprandial walk |
Primary outcome
Weight gain after postprandial walks in obese pregnant women.
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Click here for more informations about the Instituto de Medicina Integral Professor Fernando FigueiraLink provided by the sponsor.
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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.
Joao GB Alves, PhD study director
Instituto de Medicina Integral Professor Fernando Figueira
Isabelle EA Pontes, Master principal investigator
Instituto de Medicina Integral Prof. Fernando Figueira
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postprandial walks in people with Obesity and Gestational Diabetes, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 23 Jul 2020. 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 Brazil. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain after postprandial walks in obese pregnant women. (time frame: 8 weeks). 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 23 Jul 2020.