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Early Prevention of Childhood Obesity: an Active Pregnancy

13. november 2014 opdateret af: María Perales Santaella, Technical University of Madrid
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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

1100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Styring
Stillesiddende gravide
Eksperimentel: 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
Adfærdsmæssigt: A supervised physical exercise program

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Technical University of Madrid

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2014

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Forventet)

1. april 2018

Datoer for studieregistrering

Først indsendt

31. marts 2014

Først indsendt, der opfyldte QC-kriterier

7. april 2014

Først opslået (Skøn)

10. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. november 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. november 2014

Sidst verificeret

1. oktober 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Prevention childhood obesity

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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