Efficacy of Behavioral Therapy and Exercise in Gestational Diabetes Mellitus (GDM)
Randomized Comparative Trial on the Efficacy of Behavioral Therapy, Exercise and Their Combination in Gestational Diabetes Mellitus (GDM).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Women with gestational diabetes (GDM) are at increased risk of adverse pregnancy and neonatal outcomes. It is estimated that most women diagnosed with GDM can achieve targeted glycemic goals with nutrition therapy alone. A moderate exercise is recommended to lower serum glucose and to improve insulin sensitivity. Despite this, few reports examine the effect of exercise on glucose intolerance during pregnancy. Furthermore, no trial on the efficacy of behavioral treatment in women with GDM is available.
The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Turin, Italia, 10126
- University of Turin
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Gestational age between 24 and 26 weeks
- Diagnosis of GDM at the 75g oral glucose tolerance test (OGTT)
- Singleton pregnancy
Exclusion Criteria:
- Body mass index > 40 or < 12kg/m2
- Any known diseases (pre-existing diabetes mellitus, cardiovascular diseases, liver/kidney diseases, cancers, arterial hypertension)
- Patients on any drugs
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Trening
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The exercise groups will be advised to walk at least 20-minute a day.
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Ingen inngripen: Diet alone
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|
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Eksperimentell: Behavioral therapy
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General written dietary recommendations (about cooking, lowering sugar intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out.
A brief written guide on behavior change.
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Eksperimentell: Behavioral therapy and exercise
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General written dietary recommendations (about cooking, lowering fat intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out. Written recommendations for physical activity A brief written guide on behavior change |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum fasting glucose values.
Tidsramme: Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
|
To investigate changes from baseline in serum fasting glucose values in each arm with a 2x2 factorial design.
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Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum fasting insulin values
Tidsramme: At recruitment (at 24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
|
To investigate changes from baseline in serum fasting insulin values in each arm.
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At recruitment (at 24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
|
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The need for insulin therapy
Tidsramme: At recruitment and at the end of follow-up (38 weeks)
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The need for insulin therapy in each arm
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At recruitment and at the end of follow-up (38 weeks)
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|
The number of Cesarean sections
Tidsramme: From recruitment until the date of delivery, either natural or by Caesarean section, assessed up to 42 weeks
|
The number of Cesarean sections in each arm
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From recruitment until the date of delivery, either natural or by Caesarean section, assessed up to 42 weeks
|
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The mean birth-weight of newborns
Tidsramme: From recruitment until the date of delivery, assessed up to 42 weeks
|
The mean birth-weight of newborns in each arm
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From recruitment until the date of delivery, assessed up to 42 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- sbo2010
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