Physical Activity Intervention for Gestational Diabetes (GDM)
2022年7月19日 更新者：Sarah Keim
Gestational diabetes mellitus (GDM) portends an immediate, increased risk for Type 2 diabetes mellitus (T2DM).
The increased risk associated with having GDM is compounded by excess weight retention.
Therefore, the weeks and months immediately after a GDM-complicated pregnancy present an optimal window to initiate lifestyle changes to prevent or delay T2DM.
The long-term goal is to prevent T2DM among women with GDM.
This study's objective is to evaluate the efficacy of a novel, yet simple, activity-boosting intervention on weight loss among women with GDM.
調査の概要
詳細な説明
Gestational diabetes mellitus (GDM) portends an immediate, increased risk for Type 2 diabetes mellitus (T2DM).
The increased risk associated with having GDM is compounded by excess weight retention, a common issue after any pregnancy.
Considering excess weight is the best predictor of developing T2DM, the weeks and months immediately after a GDM-complicated pregnancy present an optimal window to initiate lifestyle changes to prevent or delay T2DM.
The long-term goal is to prevent T2DM among women with GDM.
This study's objective is to evaluate the efficacy of a novel, yet simple, activity-boosting intervention on weight loss among women with GDM in a parallel two-arm randomized controlled trial (n=80 women/arm, N=160).
The intervention uses ankle weights (2.5 pounds [1.1 kg]) worn on each ankle during routine daily activities (e.g., cleaning, cooking, child care) to increase energy expenditure.
The central hypothesis, based on existing literature and preliminary data, is that postpartum women with GDM will adopt an intervention that requires minimal additional time outside of their daily activities.
We anticipate that this will result in additional weight loss that is clinically significant when compared with controls who only receive standard information on recommended physical activity.
The rationale for the proposed research is that once an intervention that both improves T2DM factors and is easily adopted by women with GDM is known, early intervention specific to this restricted timeframe can be implemented.
研究の種類
介入
入学 (実際)
75
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。
研究場所
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Ohio
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Columbus、Ohio、アメリカ、43205
- Nationwide Children's Hospital
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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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- Age 18+ years
- Diagnosed with GDM in current pregnancy
- English language ability adequate for participation
- Plan to remain in the area for study duration
- Ability to provide informed consent
Exclusion Criteria:
- Prior Type 1 or Type 2 diabetes
- Pregnant with multiples (e.g., twin, triplets, etc.)
- Premature infant [<35 completed weeks gestation (assessed after delivery, before randomization)]
- Heart disease, serious illness, or conditions that may impede or prohibit participation in either study arm
- Pre-pregnancy BMI <18.5 (underweight)
- Live outside 35 mile radius of Ohio State University
- Woman is an appointed surrogate
- Infant will be adopted after delivery
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：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：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 |
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実験的：Intervention
Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week, ankle weights (2.5 pounds [1.1 kg]/ankle), instructions on ankle weight usage (wear during normal activity for 2 hours/day, 7 days/week).
The weight type and weight amount were chosen based on previously published literature and used in our preliminary work.
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Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week, ankle weights (2.5 pounds [1.1 kg]/ankle), documentation for ankle weight usage, an accelerometer, and instructions for accelerometer usage.
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プラセボコンパレーター：Control
All women in the control group will receive the standard recommendation for engaging in 150 minutes of physical activity per week.
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Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week.
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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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Weight loss
時間枠：NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Postpartum weight loss will be defined as weight change from initial weigh-in at NCH Visit 1 to final weigh-in at NCH Visit 2. Weight will be measured in person using the Tanita.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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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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Body Fat %
時間枠：NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Percent body fat will be defined as the change in initial measurement at NCH Visit 1 to final measurement at NCH Visit 2. Percent body fat will be measured in person using the Tanita.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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BMI
時間枠：NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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BMI will be defined as the change from initial measurement at NCH Visit 1 to final measurement at NCH Visit 2. BMI will be measured using the Tanita for weight and obstetric medical record for height.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Waist-hip Ratio
時間枠：NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Waist circumference (cm) will be assessed at the middle point between the ribs and the iliac crest, with the participant standing.
Hip circumference (cm) will be measured at the widest circumference of the buttocks.
Change in circumference will be defined as the change from initial measurement at NCH Visit 1 to final measurement at NCH Visit 2. Waist-hip ratio will be measured in person using metric cloth tape.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Oral Glucose Tolerance Test (OGTT)
時間枠：NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
A fasting 2-hour, 75g OGTT will be conducted during both NCH visits.
Glucose tolerance will be measured in mg/dL.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: HOMA
時間枠：NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
Insulin sensitivity (β-cell function) will be measured using the Matsuda index and HOMA-IR.
Matsuda index score and HOMA-IR will be determined based on insulin values (μU/mL) and glucose values (mg/dL) obtained from the OGTT.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Hemoglobin A1c (HbA1c)
時間枠：NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
HbA1c will be analyzed as a percentage.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Leptin
時間枠：NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
Fasting serum leptin will be measured in ng/mL.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: High sensitivity c-reactive protein (hs-CRP)
時間枠：NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
hsCRP will be measured in mg/L.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Adiponectin
時間枠：NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
Adiponectin will be measured in µg/mL.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Lipid Panel
時間枠：NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
Lipids will be analyzed including total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides.
Lipids will be measured in mg/dL.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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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。
スポンサー
捜査官
- 主任研究者：Sarah Keim, PhD, MA, MS、Nationwide Children's Hospital
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 (実際)
2018年9月10日
一次修了 (実際)
2022年2月22日
研究の完了 (実際)
2022年7月1日
試験登録日
最初に提出
2018年9月5日
QC基準を満たした最初の提出物
2018年9月7日
最初の投稿 (実際)
2018年9月10日
学習記録の更新
投稿された最後の更新 (実際)
2022年7月20日
QC基準を満たした最後の更新が送信されました
2022年7月19日
最終確認日
2022年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。