Weight GainaquapregNCT02602106
Regular Aquatic Activities and Pregnancy Outcomes
A study testing Aquatic activities intervention in people with Weight Gain, run by Universidad Politecnica de Madrid at 1 site in Spain.
Trial summary
Aquatic activities is one of the most attractive physical exercise during pregnancy, especially during the third trimester. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Gain
- What is being tested?
- Aquatic activities intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2011to Jun 2017
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnant women without any medical or obstetric complication to practice moderate exercise
- Being able to communicate in Spanish
Who cannot join
- Being interesting in the study after 16 weeks of gestation
- Having obstetric contraindications
- Not attended regular to the exercise program
Trial locations and contacts
1 site in 1 country.
Mariano Bacchi contact
Spain1 site, 1 recruiting
- Recruiting
Thecnical University of Madrid
Madrid, Madrid, 28040
Rubén Barakat, PhD, barakatruben@gmail.com
Mariano Bacchi, marianobacchi@gmail.com
About this study
Official title: Effects of Regular Aquatic Activities on Pregnancy Outcomes
Aquatic activities is one of the most attractive physical exercise during pregnancy, especially during the third trimester.
Read the detailed description
The aim of this study was to evaluate the effect of moderate regular aquatic exercise during pregnancy on maternal and fetus outcomes.
- Conditions
- Weight Gain
- Being tested
- Aquatic activities intervention
- Keywords
- Aquatic activities, Aerobic exercise, Resistance exercise, Pregnancy, Maternal weight gain, birthweight
- Medical subject headings
- Weight Gain, Gestational Weight Gain, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic activities interventionBehavioural
Women were suggested to exercise regularly through aquatic activities. A professional in physical exercise and sports designed and conducted the aquatic exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The aquatic exercise program included a total of three 50-55 minutes session per week. Pregnant women started at 9 weeks and finished at 38-39 weeks.
Each session included 10 minutes of warm up and 10 minutes of cool down including an specific pelvic floor muscle training. The core section of the session included aerobic and strength moderate exercise in water during 25 to 30 minutes Receives: Behavioral: Aquatic activities intervention |
| Control group | No intervention | Sedentary healthy pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal gestational weight gain
Maternal weight gain was collected at the end of pregnancy as well as before getting pregnant (pre-gestational weight gain)
Measured: 40-42 weeks
Birthweight
Birth weight was collected at delivery
Measured: 37-42 weeks
Secondary outcomes (3)
Number of participants with adverse pregnancy outcomes as assessed by medical records
Other health baby outcomes at delivery
Measured: 37-42 weeks
Gestational age
Gestational age of pregnancy
Measured: 37-42 weeks
Maternal blood pressure and gestational diabetes as assessed by medical records
Blood pressure, gestational diabetes...
Measured: 9 to 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startJun 2011
- Primary completionSep 2012
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Politecnica de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruben Barakat Carballo, Universidad Politecnica de Madrid
- Investigators
- Ruben Barakat Carballo, PhD, Principal investigator, Technical University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602106
- Sponsor's protocol ID
- UFLO_UPM_12
- Acronym
- aquapreg
- Status last verified
- Oct 2015
- First submitted
- 30 Oct 2015
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bacchi M, Mottola MF, Perales M, Refoyo I, Barakat R. Aquatic Activities During Pregnancy Prevent Excessive Maternal Weight Gain and Preserve Birth Weight: A Randomized Clinical Trial. Am J Health Promot. 2018 Mar;32(3):729-735. doi: 10.1177/0890117117697520. Epub 2017 Mar 9.
PubMed 28279085
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Regular Aquatic Activities on Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT02602106
- Acronym / sponsor ID
- aquapreg / UFLO_UPM_12
- Conditions
- Weight Gain
- Keywords
- Aquatic activities, Aerobic exercise, Resistance exercise, Pregnancy, Maternal weight gain, birthweight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universidad Politecnica de MadridUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 11 Nov 2015 (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.
Aquatic activities is one of the most attractive physical exercise during pregnancy, especially during the third trimester.
Detailed description
The aim of this study was to evaluate the effect of moderate regular aquatic exercise during pregnancy on maternal and fetus outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Aquatic activities interventionThe aquatic exercise program included a total of three 50-55 minutes session per week. Pregnant women started at 9 weeks and finished at 38-39 weeks. Each session included 10 minutes of warm up and 10 minutes of cool down including an specific pelvic floor muscle training. The core section of the session included aerobic and strength moderate exercise in water during 25 to 30 minutes |
| Control group | No intervention | –Sedentary healthy pregnant women |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy pregnant women without any medical or obstetric complication to practice moderate exercise
- Being able to communicate in Spanish
Key exclusion criteria (3 listed)
- Being interesting in the study after 16 weeks of gestation
- Having obstetric contraindications
- Not attended regular to the exercise program
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 |
|---|---|---|
| Aquatic activities interventionWomen were suggested to exercise regularly through aquatic activities. A professional in physical exercise and sports designed and conducted the aquatic exercise program. | Behavioural | Intervention group |
Primary outcome
Maternal gestational weight gain
Time frame: 40-42 weeks
Maternal weight gain was collected at the end of pregnancy as well as before getting pregnant (pre-gestational weight gain)
Birthweight
Time frame: 37-42 weeks
Birth weight was collected at delivery
3 secondary outcomes
Number of participants with adverse pregnancy outcomes as assessed by medical records
Time frame: 37-42 weeks
Gestational age
Time frame: 37-42 weeks
Maternal blood pressure and gestational diabetes as assessed by medical records
Time frame: 9 to 42 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
- Derived from this study: PubMed 28279085Bacchi M, Mottola MF, Perales M, Refoyo I, Barakat R. Aquatic Activities During Pregnancy Prevent Excessive Maternal Weight Gain and Preserve Birth Weight: A Randomized Clinical Trial. Am J Health Promot. 2018 Mar;32(3):729-735. doi: 10.1177/0890117117697520. Epub 2017 Mar 9.
Related trials for Weight Gain
Not yet recruiting
Weight Gain in Pediatric Leukemia Survivors
Leukemia, Pediatric Acute Lymphoblastic Leukemia
Recruiting
Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula
Healthy Term Infants
Recruiting
Adapting Exposure for Adolescent AN
Anorexia Nervosa
RecruitingObservational study
Mother and Offspring's Nutritional Status -Pregnancy After Maternal Bariatric Surgery
Bariatric Surgery, Pregnency
Recruiting
Genetic Risk, Parental Feeding Practices, and Appetitive Traits in Early Life
Childhood Obesity
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.
Mariano Bacchi contact
Ruben Barakat Carballo, PhD principal investigator
Technical University of Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic activities intervention in people with Weight Gain, run by Universidad Politecnica de Madrid at 1 site in Spain.
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 2 inclusion and 3 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 11 Nov 2015. 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 Spain. 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?
Contact Rubén O Barakat Carballo, PhD (913364120 ext. 4120, barakatruben@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal gestational weight gain (time frame: 40-42 weeks). 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?
On the ClinicalTrials.gov record for NCT02602106, which also lists 1 linked publication.
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 11 Nov 2015.