- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02109588
Early Prevention of Childhood Obesity: an Active Pregnancy
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Madrid, Spanien, 28040
- Rekrytering
- Universidad Politécnica de Madrid
-
Kontakt:
- María Perales Santaella, PhD student
- Telefonnummer: 913364081
- E-post: m.perales.santaella@gmail.com
-
Kontakt:
- Ruben Barakat, PhD
- Telefonnummer: 913364120
- E-post: barakatruben@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Kontrollera
Stillasittande gravida kvinnor
|
|
|
Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Body mass index of the offsprings
Tidsram: 0-24 postpartum months
|
Body mass index was measured several times from 0 to 24 months
|
0-24 postpartum months
|
|
Fetus body composition
Tidsram: 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
Tidsram: 40-42 weeks of gestation
|
Maternal weight gain during pregnancy
|
40-42 weeks of gestation
|
|
Changes in Baby motor development
Tidsram: 0-24 postpartum months
|
Baby motor development was measured after delivery
|
0-24 postpartum months
|
|
Recovery time to pre-gestational weight
Tidsram: 6-12 postpartum months
|
The time needed to recovery the pre-gestational weight was assessed.
|
6-12 postpartum months
|
|
Glycemia level of the offsprings
Tidsram: 0-24 postpartum months
|
Glycemia level of the offsprings was measured until 24 months
|
0-24 postpartum months
|
|
Postpartum depression
Tidsram: 0-12 postpartum months
|
The level of maternal depression was measured after delivery
|
0-12 postpartum months
|
|
Change from baseline in Body image satisfaction
Tidsram: 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
Tidsram: up to 36 weeks
|
Maternal quality of life was measured during and after pregnancy
|
up to 36 weeks
|
|
Placenta measurements
Tidsram: At delivery
|
Placenta measurements were collected at labor
|
At delivery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Maternal outcomes
Tidsram: At delivery
|
Type of labor, stage of labor and some other maternal variables were measured at delivery
|
At delivery
|
|
Control of physical activity
Tidsram: 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
Tidsram: 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
Tidsram: At delivery
|
Fetus outcomes were measured at delivery: Apgar score, PH umbilical cord, size and height of the baby, head circumference
|
At delivery
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Prevention childhood obesity
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