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Monitored Home Exercise in Pregnancy

2020年9月16日 更新者:Johns Hopkins University

A Randomized Controlled Trial of the Feasibility and Adherence of a Prescribed, Monitored Home Exercise Program in High Risk Pregnant Women

The Study Investigators intend to study the adherence to and effect of a prescribed, monitored at-home exercise regimen in a pregnant population at risk for gestational diabetes, with a specific goal of understanding factors relating to adoption and performance of regular, sustained physical activity.

調査の概要

詳細な説明

The obesity epidemic has affected the reproductive age population with a resultant increase in Gestational Diabetes Mellitus (GDM). Two to 10% of pregnant women are now diagnosed with gestational diabetes, imposing significant increased risk of maternal and fetal/neonatal morbidity and mortality.

Diabetes and obesity can both be combated by participating in daily physical activity, and has been shown to be beneficial for women of all ages, including women that are pregnant. The health benefits of exercise in pregnancy have been extensively studied, demonstrating improved pregnancy outcomes [both maternal (decreased gestational weight gain, decreased rates of cesarean section, and reduced rates of pregnancy induced complications such as hypertension and pre-eclampsia) and neonatal (reduction in proportion of large for gestational age infants)] with no evidence of harm when not contraindicated. Research should now focus on determining the most feasible, constructive, and efficient methods to improve fitness in pregnant women.

Pregnancy provides an ideal opportunity to focus on physical health and fitness; however, physical activity recommendations are rarely met and physical activity consistently decreases in pregnancy. With the development of mobile, technology-based interventions, at-home fitness regimens are now more accessible, thus reducing logistical constraints and burdens posed by traditional physical activity interventions. Moreover, the sustainability of at-home fitness regimens may be more successful long-term/post-intervention due to ease of engagement and more personalized motivational tools. Finally, wearable technology provides real-time feedback of progress and compliance to the intervention team, allowing improved monitoring of goals and compliance. In this way, contemporaneous, mobile health technology can maximize patient care by providing a novel, efficient, low burden, and scalable method to pursue pregnancy fitness, the economic implications of which could be significant.

The objective of this study is to determine the adherence to and effect of a prescribed, monitored at-home exercise regimen in a pregnant population at risk for gestational diabetes, with a specific goal of understanding factors relating to adoption and performance of regular, sustained physical activity.

There will be two arms of the study: an intervention group that will be enrolled in the BurnAlong program as well as receive FitBit heart rate + activity monitors to track adherence rates to the prescribed exercise regimen on BurnAlong, with subsequent motivational interventions triggered if compliance varies from prescription, and a comparison group who will receive standard obstetric care, which will include counseling about diet and exercise utilizing American Congress of Obstetricians and Gynecologists (ACOG) guidelines and literature, as well as a FitBit heart rate + activity monitor to track activity levels via step count. The project team will not interact with the comparison group regarding the patient's activity levels during the study duration.

A sample size of 25 women for each arm of the study (50 women total) will be recruited. Basic demographic data will be obtained for all enrolled subjects, including age, parity, pre-pregnancy BMI, family history of diabetes, history of GDM (and number of previously affected pregnancies), preterm birth history, and baseline activity level (type of job, exercise, hours of standing). All participants will be asked to fill out a physical activity in pregnancy readiness survey as well as a baseline, previously validated international physical activity questionnaire, which will be utilized for comparison to activity level data collected during the study period. All enrolled patients will receive a FitBit heart rate + activity monitor, which will provide overall activity data in the form of steps per day through the duration of the trial. Those randomized to the intervention group will also utilize the FitBit during exercise sessions to provide data on duration, heart rate, and intensity, all of which will confirm that exercise is being accomplished as prescribed. This immediate exercise compliance feedback will enable automated motivational factors to engage the patient and optimize their continued exercise participation. Data regarding mode of delivery as well as infant details will be collected by chart review by the research team. Long term follow up may be obtained via email surveys, thus patient emails will be obtained at the time of enrollment.

研究の種類

介入

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

    • Maryland
      • Baltimore、Maryland、アメリカ、21205
        • Johns Hopkins Hospital

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

はい

受講資格のある性別

女性

説明

Inclusion Criteria:

  • 18 years of age or greater
  • Singleton gestation
  • History of gestational diabetes
  • OR
  • BMI ≥30
  • OR
  • Significant family history of diabetes (two or more first degree relatives with DM)

Exclusion Criteria:

  • Non-English or non-Spanish speaking patients
  • Women unwilling to provide consent
  • Patients with current diagnosis of diabetes
  • Multiple gestation
  • Medical or pregnancy complications and/or comorbidities that preclude exercise in pregnancy
  • Unwillingness to commit to the prescribed exercise program

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: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
実験的:Physical Activity Intervention
Patients will be allocated to a physical activity intervention to be performed 3-5 days per week
Patients will be enrolled in the BurnAlong program as well as receive FitBit heart rate + activity monitors to track adherence rates to the prescribed exercise regimen on BurnAlong, with subsequent motivational interventions triggered if compliance varies from prescription
介入なし:Control
Patients will receive standard counseling regarding activity recommendations in pregnancy

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
Adherence rate
時間枠:20 weeks
Total number of performed exercise sessions divided by prescribed exercise sessions (3 per week at minimum)
20 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Gestational Diabetes
時間枠:20 weeks
Development of Gestational diabetes as determined by routine 1 hour and then subsequent 3 hour glucose testing results
20 weeks
Maternal Weight Gain
時間枠:20 weeks
measured in kilograms
20 weeks
Gestational age at delivery
時間枠:One year
Infant's gestational age at delivery
One year
Rate of Cesarean delivery
時間枠:One year
measured as the number of cesarean deliveries per total number of deliveries
One year
Infant weight
時間枠:One year
Infant weight in grams measured post delivery
One year
Neonatal Apgar scores
時間枠:1, 5, and 10 minutes of neonatal life
An assessment of neonatal wellbeing measured at 1, 5, and 10 minutes post-delivery, and is measured on a scale of 0-9, with 9 being the highest, and 0 being the lowest.
1, 5, and 10 minutes of neonatal life
Neonatal Intensive Care Unit (NICU) Admission Rate
時間枠:One year
Rate of admission of infants post-delivery to the NICU
One year
Neonatal hypoglycemia rates
時間枠:One year
Number of infants with hypoglycemia divided by the total number of delivered infants
One year

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:Jeanne Sheffield, MD、Johns Hopkins University

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

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11月1日

一次修了 (実際)

2019年10月8日

研究の完了 (実際)

2019年10月8日

試験登録日

最初に提出

2018年5月3日

QC基準を満たした最初の提出物

2018年6月7日

最初の投稿 (実際)

2018年6月11日

学習記録の更新

投稿された最後の更新 (実際)

2020年9月18日

QC基準を満たした最後の更新が送信されました

2020年9月16日

最終確認日

2019年11月1日

詳しくは

本研究に関する用語

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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

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いいえ

米国FDA規制機器製品の研究

いいえ

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