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).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
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Turin, Italien, 10126
- University of Turin
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Övning
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The exercise groups will be advised to walk at least 20-minute a day.
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Inget ingripande: Diet alone
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Experimentell: 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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Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Serum fasting glucose values.
Tidsram: Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
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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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Serum fasting insulin values
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: From recruitment until the date of delivery, assessed up to 42 weeks
|
The mean birth-weight of newborns in each arm
|
From recruitment until the date of delivery, assessed up to 42 weeks
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
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
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- sbo2010
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