Effect of an Early and Intensified Nutritional Intervention on the Risk of Developing Gestational Diabetes Mellitus (MedDiet in GDM)
Effect of an Early and Intensified Nutritional Intervention Based on a Mediterranean Diet (MedDiet) in Women With Clinical-genetic Risk of Developing Gestational Diabetes Mellitus (GDM): a Randomized, Parallel, Interventional, Controlled Clinical Trial
The goal of this clinical trial is to learn if a nutritional intervention based on a Mediterranean diet (MedDiet), initiated early in pregnancy, reduces the incidence of gestational diabetes mellitus (GDM) and other adverse maternal, fetal and obstetric events in pregnant women considered high-risk. It will also learn about the stratification of GDM risk based on clinical, anthropometric, analytical and genetic characteristics.
The main questions it aims to answer are:
- Does the nutritional intervention based on MedDiet reduce the incidence of GDM in women with high risk?
- How can we stratify the risk of GDM? Researchers will compare an advanced nutritional intervention based on a Mediterranean diet to standard care (general recommendations given at the beginning of pregnancy).
Participants will:
- Receive intensive nutritional counselling or standard regular recommendations during the first trimester of pregnancy.
- Visit the clinic at the time of the first ultrasound (gestational week 8-11) and at the time of screening for GDM (gestational week 24-26).
- Undergo a genetic test performed with a buccal swab.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ana M. Ramos-Levi, MD., PhD.
- 電話番号：+33696938427
- メール：ana_ramoslevi@hotmail.com
研究場所
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Madrid
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Madrid、Madrid、スペイン、28040
- Hospital Clinico San Carlos
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コンタクト：
- Ana M. Ramos-Levi, M.D., PhD.
- 電話番号：+34696938427
- メール：ana_ramoslevi@hotmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Unassisted single pregnancy;
- Age between 18 and 50 years old;
- Fasting blood glucose <92 mg/dl in the first gestational blood test;
- First trimester ultrasound before the 12th gestational week.
Exclusion Criteria:
- Multiple or assisted pregnancies;
- Any pregestational illness or pregestational treatment that may affect pregnancy;
- Known intolerance/allergy to any component of the nutritional intervention.
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし：Standard treatment
The nutritional intervention will consist of providing information on healthy lifestyle measures through an 8-minute informational video (accessible via QR code at the consultation room or the permanent link https://www.youtube.com/watch?v=Qgcz5t9B9WI).
Routine obstetric follow-up does not involve subsequent monitoring of adherence to these recommendations, beyond the usual follow-up.
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実験的：Advanced treatment
A specific nutritional intervention consisting of a group session that will last approximately one hour, led by a nutritionist from the research team.
This session will explain in detail the key aspects of the MedDiet: consumption of >40 ml/day of extra virgin olive oil, 30 g of nuts per day, 3-4 pieces of whole fruit (not juice), homemade stir-fries, 2-3 servings of vegetables and/or salads per day, 2-3 servings per day of low-fat dairy products, whole grains, 2-3 servings of legumes per week, consumption of fish, limiting the consumption of red meat, and avoiding ultra-processed products, sliced bread, soft drinks, juices, fast food, and pre-cooked products.
Two telephonic interviews will be scheduled for follow-up around gestational weeks 16 and 20 to provide motivation and assess and reinforce adherence to these recommendations.
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The nutritional intervention consists of a 1-hour group session led by a nutritionist from the research team.
Includes a detailed description of the key aspects of the MedDiet: consumption of >40 ml/day of extra virgin olive oil, 30 g of nuts per day, 3-4 pieces of whole fruit (not juice), homemade stir-fries, 2-3 servings of vegetables and/or salads per day, 2-3 servings per day of low-fat dairy products, whole grains, 2-3 servings of legumes per week, consumption of fish, limiting the consumption of red meat, and avoiding ultra-processed products, sliced bread, soft drinks, juices, fast food, and pre-cooked products.
In addition, 2 telephonic interviews for follow-up (gestational weeks 16 and 20) to reinforce adherence and emphasize consumption of >40 ml/day of extra virgin olive oil, 30 g of nuts per day, 3-4 pieces of whole fruit (not juice), daily vegetables and daily physical activity.
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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 |
|---|---|---|
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Incidence of gestational diabetes mellitus
時間枠：From enrollment (gestational week 8-11) to the time of screening for gestational diabetes mellitus (gestational week 24-26)
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The general objective of this study is to determine whether an advanced nutritional intervention based on Mediterranean diet reduces the incidence of gestational diabetes mellitus and other adverse maternal-fetal obstetric and endocrine-metabolic events in pregnant women considered high-risk based on a risk score derived from the interaction between associated genetic polymorphisms, baseline clinical characteristics, and anthropometric characteristics of pregnant women. The primary outcome is the comparison of the frequency of GDM, according to IADPSG criteria, between the MedDiet intervention group and the standard treatment group in women at high risk according to the calculated risk of developing GDM. |
From enrollment (gestational week 8-11) to the time of screening for gestational diabetes mellitus (gestational week 24-26)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Frequency of maternal complications
時間枠：From enrollment (gestational week 8-11) to delivery
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Frequency of maternal complications between the MedDiet intervention group and the standard treatment group in women at high risk according to the calculated risk of developing GDM.
Variables for this outcome include: maternal weight, weight gain; risk score; frequency of maternal complications (hypertension, eclampsia, infections, carbohydrate metabolism disorders - defined as alterations in normal levels of at least one of the following: fasting glucose, HbA1c, C-peptide, insulin, HOMA-IR)
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From enrollment (gestational week 8-11) to delivery
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Frequency of fetal complications
時間枠：From enrollment (gestational week 8-11) to delivery and neonatal period
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Comparison of the frequency of fetal complications between the MedDiet intervention group and the standard treatment group in high-risk women, based on the calculated risk of developing gestational diabetes mellitus (GDM).
Variables for this outcome include: birth weight, hypoglycemia, potassium abnormalities, calcium abnormalities, polycythemia, admission to the neonatal intensive care unit (NICU).
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From enrollment (gestational week 8-11) to delivery and neonatal period
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Frequency of obstetric complications
時間枠：From enrollment (gestational week 8-11) to delivery and immediate postpartum
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Comparison of the frequency of obstetric complications between the MedDiet intervention group and the standard treatment group in women at high risk of developing GDM.
Variables for this outcome include: type of delivery, dystocia, lacerations during delivery, preterm or postterm delivery (gestational week at delivery).
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From enrollment (gestational week 8-11) to delivery and immediate postpartum
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
- PI25_01413
- 25/902-EC_X (その他の識別子：Ethics Committee of the Hospital Clinico San Carlos)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The original protocols of the study will be stored in a locked office in the Department of Endocrinology at our Hospital. De-identified data will be saved on a secure electronic database. Specifically, we will use REDCap® (Vanderbilt University) software, which is known to be a secure, browser-based web application (http://project-redcap.org), for data entry and analysis.
All participant data related to the study, including scales and questionnaires, will be completed in paper form, and will then be recorded and uploaded in the REDCap®Electronic Data Collection Record (eCRD).
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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