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).
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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-
-
Turin、イタリア、10126
- University of Turin
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：エクササイズ
|
The exercise groups will be advised to walk at least 20-minute a day.
|
|
介入なし：Diet alone
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|
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実験的：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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実験的：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum fasting glucose values.
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum fasting insulin values
時間枠：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
時間枠：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
時間枠：From recruitment until the date of delivery, either natural or by Caesarean section, assessed up to 42 weeks
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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
|
|
The mean birth-weight of newborns
時間枠：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
|
協力者と研究者
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- sbo2010
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