PregnancyNCT02109588
Early Prevention of Childhood Obesity: an Active Pregnancy
A study testing A supervised physical exercise program in people with Pregnancy, run by Technical University of Madrid at 1 site in Spain.
Trial summary
The main aim of this study was to examine the effect of a supervised physical exercise program on the prevention of childhood obesity and its impact on the motor development of the offspring. 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
- Pregnancy
- What is being tested?
- A supervised physical exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2014to Apr 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
- Being able to communicate in spanish
- Giving birth at Hospital Universitario de Torrejón, hospital Universitario de Puerta de Hierro and Hospital Universitario Severo Ochoa (Madrid).
Who cannot join
- Multiparity
- Obstetrician complications
- Being interested in the study after 16 weeks
- Not being regular in physical exercise program
- Younger than 18 years old
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Politécnica de Madrid
Madrid, Madrid, 28040
María Perales Santaella, PhD student, 913364081, m.perales.santaella@gmail.com
Rubén Barakat, PhD, 913364120, barakatruben@gmail.com
About this study
The main aim of this study was to examine the effect of a supervised physical exercise program on the prevention of childhood obesity and its impact on the motor development of the offspring.
Read the detailed description
The environment where the fetus growths up is essential for the risk of developing some diseases in later life, such as obesity. Exercise has showed being useful in the prevention on excessive maternal weight gain which is linked to fetus weight.
- Conditions
- Pregnancy
- Being tested
- A supervised physical exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A supervised physical exercise programBehavioural
Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training
Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Sedentary pregnant women |
| Exercise group | Experimental | Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training
Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate Receives: Behavioral: A supervised physical exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index of the offsprings
Body mass index was measured several times from 0 to 24 months
Measured: 0-24 postpartum months
Fetus body composition
Fetus body composition (percentage of fat) was measured several times from 0 to 24 months
Measured: 0-24 postpartum months
Change from baseline in Maternal gestational weight gain
Maternal weight gain during pregnancy
Measured: 40-42 weeks of gestation
Changes in Baby motor development
Baby motor development was measured after delivery
Measured: 0-24 postpartum months
Recovery time to pre-gestational weight
The time needed to recovery the pre-gestational weight was assessed.
Measured: 6-12 postpartum months
Glycemia level of the offsprings
Glycemia level of the offsprings was measured until 24 months
Measured: 0-24 postpartum months
Postpartum depression
The level of maternal depression was measured after delivery
Measured: 0-12 postpartum months
Change from baseline in Body image satisfaction
Body image satisfaction was measured during and after pregnancy
Measured: up to 36 weeks
Changes from baseline in maternal quality of life
Maternal quality of life was measured during and after pregnancy
Measured: up to 36 weeks
Placenta measurements
Placenta measurements were collected at labor
Measured: At delivery
Secondary outcomes (4)
Maternal outcomes
Type of labor, stage of labor and some other maternal variables were measured at delivery
Measured: At delivery
Control of physical activity
Control the level of physical activity during and after pregnancy
Measured: up to 10 weeks
Changes from delivery in Health of the offspring
Health of the baby included the measurement of other variables such as blood pressure and cholesterol of the offsprings until 24 months
Measured: 0-24 postpartum months
Fetus outcomes
Fetus outcomes were measured at delivery: Apgar score, PH umbilical cord, size and height of the baby, head circumference
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2014
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Perales Santaella, Technical University of Madrid
- Investigators
- Rubén Barakat, PhD, Study director, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109588
- Sponsor's protocol ID
- Prevention childhood obesity
- Status last verified
- Oct 2013
- First submitted
- 31 Mar 2014
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prevention of Childhood Obesity: an Active Pregnancy
- ClinicalTrials.gov ID
- NCT02109588
- Acronym / sponsor ID
- Prevention childhood obesity
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Technical University of MadridUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Apr 2018 (estimated)
- First posted
- 10 Apr 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 main aim of this study was to examine the effect of a supervised physical exercise program on the prevention of childhood obesity and its impact on the motor development of the offspring.
Detailed description
The environment where the fetus growths up is essential for the risk of developing some diseases in later life, such as obesity. Exercise has showed being useful in the prevention on excessive maternal weight gain which is linked to fetus weight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Sedentary pregnant women |
| Exercise group | Experimental | Behavioral: A supervised physical exercise programSupervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
- Being able to communicate in spanish
- Giving birth at Hospital Universitario de Torrejón, hospital Universitario de Puerta de Hierro and Hospital Universitario Severo Ochoa (Madrid).
Key exclusion criteria (5 listed)
- Multiparity
- Obstetrician complications
- Being interested in the study after 16 weeks
- Not being regular in physical exercise program
- Younger than 18 years old
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 |
|---|---|---|
| A supervised physical exercise programSupervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate | Behavioural | Exercise group |
Primary outcome
Body mass index of the offsprings
Time frame: 0-24 postpartum months
Body mass index was measured several times from 0 to 24 months
Fetus body composition
Time frame: 0-24 postpartum months
Fetus body composition (percentage of fat) was measured several times from 0 to 24 months
Change from baseline in Maternal gestational weight gain
Time frame: 40-42 weeks of gestation
Maternal weight gain during pregnancy
Changes in Baby motor development
Time frame: 0-24 postpartum months
Baby motor development was measured after delivery
Recovery time to pre-gestational weight
Time frame: 6-12 postpartum months
The time needed to recovery the pre-gestational weight was assessed.
Glycemia level of the offsprings
Time frame: 0-24 postpartum months
Glycemia level of the offsprings was measured until 24 months
Postpartum depression
Time frame: 0-12 postpartum months
The level of maternal depression was measured after delivery
Change from baseline in Body image satisfaction
Time frame: up to 36 weeks
Body image satisfaction was measured during and after pregnancy
Changes from baseline in maternal quality of life
Time frame: up to 36 weeks
Maternal quality of life was measured during and after pregnancy
Placenta measurements
Time frame: At delivery
Placenta measurements were collected at labor
4 secondary outcomes
Maternal outcomes
Time frame: At delivery
Control of physical activity
Time frame: up to 10 weeks
Changes from delivery in Health of the offspring
Time frame: 0-24 postpartum months
Fetus outcomes
Time frame: At delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
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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.
Rubén Barakat, PhD study director
Universidad Politecnica de 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 A supervised physical exercise program in people with Pregnancy, run by Technical University of 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 3 inclusion and 5 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 14 Nov 2014. 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 Maria Perales Santaella, PhD student (913364081, m.perales.santaella@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index of the offsprings (time frame: 0-24 postpartum months). The study lists 10 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 14 Nov 2014.