Glucose Levels and Outcomes in Women - Mid Pregnancy (GLOW)
Up to 75% of reproductive age women are overweight, 40% are considered obese, and the prevalence of gestational diabetes mellitus (GDM) continues to rise, from 6% to 8.3% between 2016 and 2021. Currently understood GDM risk factors, such as advanced maternal age, prior history of GDM, family history of diabetes, and socioeconomic status can only explain up to 50% of cases. Related factors such as body image dissatisfaction, eating behaviors, and daily stress exposure have been linked to blood sugar metabolization, pregnancy outcomes, and the normative physiological changes that occur during pregnancy. These interrelated mechanisms may serve as additional risk factors that could help identify other women at risk of GDM. This project aims to investigate how body image dissatisfaction, eating behaviors, and daily stress exposure are associated with the metabolization of blood sugar during pregnancy.
In this study the Strahm Lab will recruit 50 pregnant women to participate in a study assessing blood sugar metabolization as it is related to stress, body image dissatisfaction, and eating behaviors. The study will use continuous glucose monitoring in concert with an ecological momentary assessment protocol to assess these interrelated factors over the course of 10 days between 14 and 28 weeks gestation.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Grace Biermann, MPH
- 電話番号：605-312-6457
- メール：strahmlab@sanfordhealth.org
研究場所
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North Dakota
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Fargo、North Dakota、アメリカ、58104
- Sanford Health
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コンタクト：
- Grace Biermann, MPH
- 電話番号：605-312-6457
- メール：grace.biermann@sanfordhealth.org
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主任研究者：
- Anna M. Strahm, PhD
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Fargo、North Dakota、アメリカ、58102
- North Dakota State University
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コンタクト：
- Grace Biermann, MPH
- 電話番号：605-312-6457
- メール：grace.biermann@sanfordhealth.org
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副調査官：
- Clayton J. Hilmert, PhD
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South Dakota
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Sioux Falls、South Dakota、アメリカ、57104
- Sanford Health
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コンタクト：
- Grace Biermann, MPH
- 電話番号：605-312-6457
- メール：grace.biermann@sanfordhealth.org
-
主任研究者：
- Anna M. Strahm, PhD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- At least 18 years old
- Healthy single baby pregnancy
- 14 to 28 weeks of pregnancy
Exclusion Criteria:
- history of diabetes
- history of gestational diabetes mellitus (GDM)
- history of cardiac disease
- history of endocrine disease
- assistive reproductive technology (IVF)
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
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 |
|---|---|---|
|
Continuous Blood Glucose via Dexcom G7
時間枠：10 days
|
Participant will wear a Dexcom G7 CGM for 10 days to measure blood glucose levels (mg/dL)
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10 days
|
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Body Image in Pregnancy Scale (BIPS)
時間枠：10 days
|
Participants will complete the full Body Image in Pregnancy Scale (BIPS) once prior to the start of the 10 day CGM/momentary assessment period and once at the end. The full BIPS scale is 36 items. It assesses body image dissatisfaction. Participants rate each item from one (strongly disagree) to five (strongly agree). Generally, lower scores indicate higher body satisfaction, while higher scores indicate higher levels of pregnancy-related body dissatisfaction/stress due to body image. Participants will receive 8 items from the scale to assess preoccupation with physical appearance and sexual attractiveness, prioritization of physical appearance over body functioning, appearance related behavioral avoidance, and dissatisfaction with body parts at least 5 times each day during the 10 day CGM/momentary assessment period. The full BIPS will be completed in REDCap. Momentary assessments will be completed via Real Time Assessment In the Natural Environment (ReTAINE). |
10 days
|
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
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。