Nutrition Counseling, Diet Quality, and Advanced Glycation End Products in Gestational Diabetes
2026年6月8日 更新者：Beyzanur Çamlıbel、Istanbul Saglik Bilimleri University
The Relationship Between Nutrition Counseling in Gestational Diabetes Mellitus and Diet Quality and Advanced Glycation End Products
This study will evaluate the relationship between structured nutrition counseling, diet quality, and advanced glycation end products in pregnant women with gestational diabetes mellitus and women with normal glucose tolerance.
Participants will be assigned to either a structured nutrition counseling group or a standard care group according to glucose tolerance status.
The counseling program will include education and follow-up on healthy eating during pregnancy, gestational diabetes management, portion control, food choices, meal planning, and cooking methods.
Diet quality, dietary habits, biochemical parameters, advanced glycation end products, gestational weight gain, and fetal outcomes will be assessed during follow-up.
調査の概要
研究の種類
介入
入学 (推定)
48
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：BEYZANUR ÇAMLIBEL, Dietitian / PhD Candidate
- 電話番号：+90 541 656 78 19
- メール：beyzanur.cmlbl@gmail.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
はい
説明
Inclusion Criteria:
- Pregnant women aged 18 to 35 years
- Singleton and first pregnancy
- Gestational age between 24 and 28 weeks at enrollment
- Diagnosis of gestational diabetes mellitus or normal glucose tolerance
- Not using insulin therapy
- Stopped smoking at least 3 months before enrollment and not using alcohol
- Willingness to participate in the study
- Ability to provide written informed consent
Exclusion Criteria:
- Current use of insulin therapy
- Active smoking
- Alcohol use
- Refusal or inability to provide written informed consent
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：NGT-Control
Pregnant women with normal glucose tolerance receiving standard obstetric care and routine dietitian consultation.
|
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
|
|
実験的：NGT-Intervention
Pregnant women with normal glucose tolerance receiving standard obstetric care plus structured nutrition counseling.
|
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
A dietitian-led structured nutrition counseling, education, and follow-up program provided in addition to standard care.
The program includes education on pregnancy, gestational diabetes mellitus, adequate and balanced nutrition, appropriate gestational weight gain, portion control, low glycemic index food choices, reduction of highly processed foods, healthy cooking methods, carbohydrate intake, and meal planning.
Follow-up will be conducted at least every two weeks by telephone, online, or face-to-face sessions.
Dietary records and weight changes will be reviewed, and individualized feedback and motivational support will be provided.
|
|
アクティブコンパレータ：GDM-Control
Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management and routine dietitian consultation.
|
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
|
|
実験的：GDM-Intervention
Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management plus structured nutrition counseling.
|
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
A dietitian-led structured nutrition counseling, education, and follow-up program provided in addition to standard care.
The program includes education on pregnancy, gestational diabetes mellitus, adequate and balanced nutrition, appropriate gestational weight gain, portion control, low glycemic index food choices, reduction of highly processed foods, healthy cooking methods, carbohydrate intake, and meal planning.
Follow-up will be conducted at least every two weeks by telephone, online, or face-to-face sessions.
Dietary records and weight changes will be reviewed, and individualized feedback and motivational support will be provided.
|
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 |
|---|---|---|
|
Diet Quality Score
時間枠：Baseline at 24-28 weeks of gestation and final assessment at 32-36 weeks of gestation
|
Diet quality will be assessed using the Diet Quality Index-International based on three-day food records.
The score ranges from 0 to 100, with higher scores indicating better diet quality.
|
Baseline at 24-28 weeks of gestation and final assessment at 32-36 weeks of gestation
|
|
Serum Advanced Glycation End Products Level
時間枠：Final assessment at approximately 32-36 weeks of gestation
|
Serum advanced glycation end products levels will be measured using serum samples obtained from residual blood collected during routine clinical tests.
Levels will be evaluated in relation to glucose tolerance status, nutrition counseling, diet quality, and dietary behaviors.
|
Final assessment at approximately 32-36 weeks of gestation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Highly Processed Food Consumption Score
時間枠：Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
|
Highly processed food consumption will be assessed using the short screening questionnaire of highly processed food consumption.
Higher scores indicate higher consumption of highly processed foods.
|
Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
|
|
Dietary Habits and Cooking Methods
時間枠：Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
|
Dietary habits and cooking methods will be assessed using a structured questionnaire including meal frequency, skipped meals, snacking habits, food preferences, cooking methods, and types of oils used in food preparation.
|
Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
|
|
Gestational Weight Gain
時間枠：Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
|
Gestational weight gain will be evaluated using maternal body weight measurements recorded during pregnancy follow-up.
|
Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
|
|
Birth Weight
時間枠：At delivery
|
Infant birth weight will be recorded in grams after delivery from obstetric and neonatal records.
|
At delivery
|
|
Gestational Age at Birth
時間枠：At delivery
|
Gestational age at birth will be recorded in completed weeks after delivery from obstetric records.
|
At delivery
|
|
Congenital Anomaly Status
時間枠：At delivery
|
The presence or absence of congenital anomaly will be recorded after delivery from obstetric and neonatal records.
|
At delivery
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2027年5月1日
研究の完了 (推定)
2027年7月1日
試験登録日
最初に提出
2026年6月3日
QC基準を満たした最初の提出物
2026年6月8日
最初の投稿 (実際)
2026年6月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月9日
QC基準を満たした最後の更新が送信されました
2026年6月8日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 25-49
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?
いいえ
IPD プランの説明
Individual participant data will not be shared because the study includes sensitive health data from pregnant women.
Data will be stored and analyzed in coded and anonymized form in accordance with the informed consent and ethics committee approval.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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