LifestyleNCT03045237
Healthy Bellies - Intervention Program During Pregnancy on Women and Newborn
A study testing physical exercises classes in people with Lifestyle and Physical Activity, run by University of Minho at 1 site in Portugal.
Trial summary
"Healthy Bellies" is an intervention program with pregnant women, based on the promotion of healthy lifestyles. It aims to evaluate the impact of the program in the health of both pregnant and newborn. This trial is being conducted with pregnant women, divided into control and intervention group. 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
- Lifestyle, Physical Activity, Dietary Habits
- What is being tested?
- physical exercises classes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Nov 2015to 31 Aug 2018
- 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
- Do not have any medical or obstetric contraindication for physical exercise
Who cannot join
- Haemodynamically significant heart disease;
- restrictive lung disease;
- incompetent cervix/cerclage;
- multiple gestation at risk for premature labor;
- persistent second or third trimester bleeding;
- placenta praevia after 26 weeks gestation;
Show all 21Show fewer
- premature labor during the current pregnancy;
- ruptured membranes;
- pregnancy induced hypertension;
- severe anaemia;
- unevaluated maternal cardiac arrhythmia;
- chronic bronchitis;
- poorly controlled type I diabetes;
- extreme morbid obesity;
- extreme underweight (body mass index <12);
- history of extremely sedentary lifestyle;
- intrauterine growth restriction in current pregnancy;
- poorly controlled hypertension/pre-eclampsia;
- orthopaedic limitations;
- poorly controlled seizure disorder;
- poorly controlled thyroid disease; heavy smoker).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sporty Bellies - Intervention Program During Pregnancy on Women and Newborn
"Healthy Bellies" is an intervention program with pregnant women, based on the promotion of healthy lifestyles. It aims to evaluate the impact of the program in the health of both pregnant and newborn. This trial is being conducted with pregnant women, divided into control and intervention group. Are performed 3 assessment periods: 1 - beginning of the program; 2 - postpartum; 3 - 1 month after delivery. The intervention group has a program of 3 weekly physical exercise classes and the control group has the basic information that is usually provided by health professionals. With this program, it is expected to contribute with evidence to the best practice in the field of interventions in pregnancy and improve health outcomes of both pregnant and newborn.
- Conditions
- Lifestyle, Physical Activity, Dietary Habits, Depressive Symptoms
- Being tested
- physical exercises classes
- Keywords
- Pregnancy, Physical activity, Newborn, Depressive Symptoms, Dietary habits, Healthy lifestyles
- Medical subject headings
- Motor Activity, Feeding Behavior, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exercises classesOther
3 physical exercises classes, one of them in the pool.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The program consists in 3 physical exercise classes, one of them in the pool. Receives: Other: physical exercises classes |
| Control Group | No intervention | The control group has the basic information through health professionals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity assessed with the "Pregnancy Physical Activity Questionnaire"
Evaluation through "Pregnancy Physical Activity Questionnaire"
Measured: Baseline and 1 month after delivery
Change in Dietary intake assessed with the "Food frequency questionnaire"
Evaluation through "Food frequency questionnaire"
Measured: Baseline and 1 month after delivery
Gestational Weight gain
Values are self-reported by pregnant women
Measured: 1 day after delivery
Change in Depressive Symptoms assessed with the "Edinburgh Postnatal Depression Scale"
Evaluation through "Edinburgh Postnatal Depression Scale"
Measured: Baseline, 1 day after delivery and 1 month after delivery
Weight of the baby
Self-reported by participants
Measured: 1 day after delivery
Length of the baby
Self-reported by participants
Measured: 1 day after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start1 Nov 2015
- Primary completion31 Dec 2017
- Study completion31 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LifestyleStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, Centro de Investigação em Estudos da Criança, Centro Hospitalar do Alto Ave, Câmara Municipal de Guimarães
- Responsible party
- Principal investigator, Ana Isabel Teixeira Jesus Silva, University of Minho
- Investigators
- Maria B Pereira, Study director, University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045237
- Sponsor's protocol ID
- Healthy Bellies
- Status last verified
- May 2018
- First submitted
- 28 Jan 2017
- Last updated
- 8 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sporty Bellies - Intervention Program During Pregnancy on Women and Newborn
- ClinicalTrials.gov ID
- NCT03045237
- Acronym / sponsor ID
- Healthy Bellies
- Conditions
- Lifestyle, Physical Activity, Dietary Habits, Depressive Symptoms
- Keywords
- Pregnancy, Physical activity, Newborn, Depressive Symptoms, Dietary habits, Healthy lifestyles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 410 participants (actual)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, Centro de Investigação em Estudos da Criança, Centro Hospitalar do Alto Ave, Câmara Municipal de Guimarães
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 7 Feb 2017 (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.
"Healthy Bellies" is an intervention program with pregnant women, based on the promotion of healthy lifestyles. It aims to evaluate the impact of the program in the health of both pregnant and newborn. This trial is being conducted with pregnant women, divided into control and intervention group. Are performed 3 assessment periods: 1 - beginning of the program; 2 - postpartum; 3 - 1 month after delivery. The intervention group has a program of 3 weekly physical exercise classes and the control group has the basic information that is usually provided by health professionals. With this program, it is expected to contribute with evidence to the best practice in the field of interventions in pregnancy and improve health outcomes of both pregnant and newborn.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: physical exercises classesThe program consists in 3 physical exercise classes, one of them in the pool. |
| Control Group | No intervention | –The control group has the basic information through health professionals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Do not have any medical or obstetric contraindication for physical exercise
Key exclusion criteria (21 listed)
- Haemodynamically significant heart disease;
- restrictive lung disease;
- incompetent cervix/cerclage;
- multiple gestation at risk for premature labor;
- persistent second or third trimester bleeding;
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 |
|---|---|---|
| physical exercises classes3 physical exercises classes, one of them in the pool. | Other | Intervention Group |
Primary outcome
Change in physical activity assessed with the "Pregnancy Physical Activity Questionnaire"
Time frame: Baseline and 1 month after delivery
Evaluation through "Pregnancy Physical Activity Questionnaire"
Change in Dietary intake assessed with the "Food frequency questionnaire"
Time frame: Baseline and 1 month after delivery
Evaluation through "Food frequency questionnaire"
Gestational Weight gain
Time frame: 1 day after delivery
Values are self-reported by pregnant women
Change in Depressive Symptoms assessed with the "Edinburgh Postnatal Depression Scale"
Time frame: Baseline, 1 day after delivery and 1 month after delivery
Evaluation through "Edinburgh Postnatal Depression Scale"
Weight of the baby
Time frame: 1 day after delivery
Self-reported by participants
Length of the baby
Time frame: 1 day after delivery
Self-reported by participants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Maria B Pereira study director
University of Minho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical exercises classes in people with Lifestyle and Physical Activity, run by University of Minho 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 21 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 8 May 2018. 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?
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?
Change in physical activity assessed with the "Pregnancy Physical Activity Questionnaire" (time frame: Baseline and 1 month after delivery). The study lists 6 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 8 May 2018.