Early Prevention of Childhood Obesity: an Active Pregnancy
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Madrid, Spania, 28040
- Rekruttering
- Universidad Politécnica de Madrid
-
Ta kontakt med:
- María Perales Santaella, PhD student
- Telefonnummer: 913364081
- E-post: m.perales.santaella@gmail.com
-
Ta kontakt med:
- Ruben Barakat, PhD
- Telefonnummer: 913364120
- E-post: barakatruben@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Multiparity
- Obstetrician complications
- Being interested in the study after 16 weeks
- Not being regular in physical exercise program
- Younger than 18 years old
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Kontroll
Stillesittende gravide
|
|
|
Eksperimentell: Exercise group
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 |
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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Body mass index of the offsprings
Tidsramme: 0-24 postpartum months
|
Body mass index was measured several times from 0 to 24 months
|
0-24 postpartum months
|
|
Fetus body composition
Tidsramme: 0-24 postpartum months
|
Fetus body composition (percentage of fat) was measured several times from 0 to 24 months
|
0-24 postpartum months
|
|
Change from baseline in Maternal gestational weight gain
Tidsramme: 40-42 weeks of gestation
|
Maternal weight gain during pregnancy
|
40-42 weeks of gestation
|
|
Changes in Baby motor development
Tidsramme: 0-24 postpartum months
|
Baby motor development was measured after delivery
|
0-24 postpartum months
|
|
Recovery time to pre-gestational weight
Tidsramme: 6-12 postpartum months
|
The time needed to recovery the pre-gestational weight was assessed.
|
6-12 postpartum months
|
|
Glycemia level of the offsprings
Tidsramme: 0-24 postpartum months
|
Glycemia level of the offsprings was measured until 24 months
|
0-24 postpartum months
|
|
Postpartum depression
Tidsramme: 0-12 postpartum months
|
The level of maternal depression was measured after delivery
|
0-12 postpartum months
|
|
Change from baseline in Body image satisfaction
Tidsramme: up to 36 weeks
|
Body image satisfaction was measured during and after pregnancy
|
up to 36 weeks
|
|
Changes from baseline in maternal quality of life
Tidsramme: up to 36 weeks
|
Maternal quality of life was measured during and after pregnancy
|
up to 36 weeks
|
|
Placenta measurements
Tidsramme: At delivery
|
Placenta measurements were collected at labor
|
At delivery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maternal outcomes
Tidsramme: At delivery
|
Type of labor, stage of labor and some other maternal variables were measured at delivery
|
At delivery
|
|
Control of physical activity
Tidsramme: up to 10 weeks
|
Control the level of physical activity during and after pregnancy
|
up to 10 weeks
|
|
Changes from delivery in Health of the offspring
Tidsramme: 0-24 postpartum months
|
Health of the baby included the measurement of other variables such as blood pressure and cholesterol of the offsprings until 24 months
|
0-24 postpartum months
|
|
Fetus outcomes
Tidsramme: At delivery
|
Fetus outcomes were measured at delivery: Apgar score, PH umbilical cord, size and height of the baby, head circumference
|
At delivery
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Prevention childhood obesity
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .