Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants
2015年6月1日 更新者:Diane Berry, PhD, ANP-BC、University of North Carolina, Chapel Hill
The purpose of this study is to determine whether a 14 week intervention is successful in improving outcomes for women with gestational diabetes mellitus and their infants.
調査の概要
詳細な説明
Women who are diagnosed with gestational diabetes are at increased risk for developing prediabetes and type 2 diabetes.
To date, there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with gestational diabetes.
Programs are needed that intervene in the prenatal period to teach women the importance of breastfeeding to improve metabolic control and infant health and continue after birth to promote improved nutrition and exercise patterns and weight loss.
Using a two-group, repeated measures experimental design, this proposed study will test a 14-week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and type 2 diabetes, nutrition and exercise education, coping skills training, and physical activity (Phase I) and 3 months of continued monthly contact (Phase II) to help overweight women diagnosed with gestational diabetes improve metabolic, clinical, weight, adiposity, health behaviors and self-efficacy.
Trends in breastfeeding duration and intensity, maternal infant feeding behavior, infant growth trajectory (weight-for-length) will also be measured.
A total of 100 African American, bilingual Hispanic, and non-Hispanic White women diagnosed with gestational diabetes will be inducted and randomized by site to either the experimental or wait-list control group.
Data will be collected at Time 1 (Baseline at 22-36 weeks pregnant), Time 2 (6 weeks postpartum), Time 3 (4 months postpartum and completion of Phase I), Time 4 (7 months postpartum and completion of Phase II), and Time 5 (10 months postpartum and after 3 months on their own).
Primary maternal outcomes will include fasting blood glucose and weight (BMI).
Secondary maternal outcomes will include clinical outcomes (oral glucose tolerance test, insulin levels, Homeostasis Model Assessment calculation, Hemoglobin A1c, complete lipid panel, and blood pressure); adiposity (waist circumference, triceps and subscapular skin folds); health behaviors (Health Promoting Lifestyle Profile II, Adult Health Behavior Survey, and Accelerometry for 7 days); and self-efficacy (Eating Self-Efficacy, Exercise Self-Efficacy Scale, and Breastfeeding Self-Efficacy Scale).
Infant outcomes will include data on weight status (weight-for-length) and breastfeeding (weeks until stopped breastfeeding, weeks exclusively breastfed, and intensity of breastfeeding).
Data analysis will include analysis of field notes, post-intervention interviews, and recruitment and retention efforts.
Linear mixed-effects random coefficients models will be constructed to measure the effects of the intervention compared to the wait-list control group.
Increasing breastfeeding and decreasing overweight in postpartum women who were diagnosed with gestational diabetes may both improve maternal glucose homeostasis and weight and stabilize infant growth trajectory, reducing the burden of metabolic disease across two generations.
研究の種類
介入
入学 (実際)
200
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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North Carolina
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Raleigh、North Carolina、アメリカ、27610
- Wakemed
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Raleigh、North Carolina、アメリカ、27607
- UNC-Rex Health Care
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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~45年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
説明
Inclusion Criteria:
- Women between 22-36 weeks of pregnancy who are diagnosed with GDM
- A diagnosis of GDM during the current pregnancy by two or more 100g Oral Glucose Tolerance Test (OGTT) values exceeding established thresholds (fasting 95, 1h 180, 2h 155, 3h 140 mg/dL)
- Age 18-45 years old
A pre-pregnancy body mass index > 25kg/m2
- Ability to read and write in English
- Willingness to consent for themselves and their infant
Exclusion Criteria:
- They have a A1c ≥ 6.5 mg/dL (Type 2 diabetes)
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:処理
- 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 |
---|---|
実験的:intervention
Breastfeeding, progression to type 2 diabetes, nutrition, and exercise education, coping skills training, exercise training, a home-based exercise program and educational and motivational text messaging.
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Using a two-group, repeated measures experimental design, this proposed study will test a 14-week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and type 2 diabetes, nutrition and exercise education, coping skills training, and physical activity (Phase I) and 3 months of continued monthly contact (Phase II) to help overweight women diagnosed with gestational diabetes improve metabolic, clinical, weight, adiposity, health behaviors and self-efficacy.
他の名前:
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介入なし:Wait-listed control group
Wait-listed control group receive usual care delivered by their health care provider and after completion of their time in the study they are offered the intervention
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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 |
---|---|---|
fasting blood glucose
時間枠:Baseline to 10 months postpartum
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Change in fasting blood glucose in mothers
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Baseline to 10 months postpartum
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weight (body mass index)
時間枠:Baseline to 10 months postpartum
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Change in weight (body mass index)in mothers
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Baseline to 10 months 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 |
---|---|---|
oral glucose tolerance test
時間枠:Baseline to 10 months postpartum
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Change in oral glucose tolerance test in mothers
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Baseline to 10 months postpartum
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insulin levels
時間枠:Baseline to 10 months postpartum
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Change in insulin levels in mothers
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Baseline to 10 months postpartum
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homeostasis model assessment
時間枠:Baseline to 10 months postpartum
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Change in homeostasis model assessment calculation in mothers
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Baseline to 10 months postpartum
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hemoglobin A1c
時間枠:Baseline to 10 months postpartum
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Change in hemoglobin A1c in mothers
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Baseline to 10 months postpartum
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complete lipid panel
時間枠:Baseline to 10 months postpartum
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Change in complete lipid panel in mothers
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Baseline to 10 months postpartum
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blood pressure
時間枠:Baseline to 10 months postpartum
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Change in blood pressure in mothers
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Baseline to 10 months postpartum
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adiposity
時間枠:Baseline to 10 months
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Change in adiposity (waist circumference, triceps and subscapular skin folds)in mothers
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Baseline to 10 months
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health behaviors
時間枠:Baseline to 10 months postpartum
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Change in health behaviors (Health Promoting Lifestyle Profile II, Adult Health Behavior Survey, and Accelerometry for 7 days) in mothers
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Baseline to 10 months postpartum
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self-efficacy
時間枠:Baseline to 10 months postpartum
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Change in self-efficacy in mothers
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Baseline to 10 months postpartum
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infant weight status
時間枠:Birth to 10 months
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weight status (weight-for-length) in children
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Birth to 10 months
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breastfeeding
時間枠:Birth to 10 months
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Change in breastfeeding (weeks until stopped breastfeeding, weeks exclusively breastfed, and intensity of breastfeeding) in infants
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Birth to 10 months
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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。
捜査官
- 主任研究者:Diane Berry, PhD, ANP-BC、University of North Carolina, Chapel Hill
- 主任研究者:Alison Stuebe, MD、University of North Carolina, Chapel Hill
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。
一般刊行物
- Stuebe AM, Bonuck K, Adatorwovor R, Schwartz TA, Berry DC. A Cluster Randomized Trial of Tailored Breastfeeding Support for Women with Gestational Diabetes. Breastfeed Med. 2016 Dec;11(10):504-513. doi: 10.1089/bfm.2016.0069. Epub 2016 Oct 26.
- Berry DC, Neal M, Hall EG, Schwartz TA, Verbiest S, Bonuck K, Goodnight W, Brody S, Dorman KF, Menard MK, Stuebe AM. Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study. BMC Pregnancy Childbirth. 2013 Oct 10;13:184. doi: 10.1186/1471-2393-13-184.
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
2012年5月1日
一次修了 (実際)
2014年7月1日
研究の完了 (実際)
2014年7月1日
試験登録日
最初に提出
2013年3月10日
QC基準を満たした最初の提出物
2013年3月10日
最初の投稿 (見積もり)
2013年3月12日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年6月3日
QC基準を満たした最後の更新が送信されました
2015年6月1日
最終確認日
2015年6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。
Interventionの臨床試験
-
University of MichiganNational Institute on Drug Abuse (NIDA)募集
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University of PittsburghCenters for Disease Control and Preventionまだ募集していません暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
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University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
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Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺
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Munich Municipal HospitalTechnical University of Munich; University of Regensburgわからない