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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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

75

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ohio
      • Columbus、Ohio、美国、43205
        • Nationwide Children's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
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.
安慰剂比较:Control
All women in the control group will receive the standard recommendation for engaging in 150 minutes of physical activity per week.
Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Weight loss
大体时间:NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)

次要结果测量

结果测量
措施说明
大体时间
Body Fat %
大体时间:NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
BMI
大体时间:NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Waist-hip Ratio
大体时间:NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Oral Glucose Tolerance Test (OGTT)
大体时间:NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: HOMA
大体时间:NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Hemoglobin A1c (HbA1c)
大体时间:NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis. HbA1c will be analyzed as a percentage.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Leptin
大体时间:NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: High sensitivity c-reactive protein (hs-CRP)
大体时间:NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis. hsCRP will be measured in mg/L.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Adiponectin
大体时间:NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis. Adiponectin will be measured in µg/mL.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Lipid Panel
大体时间:NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Sarah Keim, PhD, MA, MS、Nationwide Children's Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年9月10日

初级完成 (实际的)

2022年2月22日

研究完成 (实际的)

2022年7月1日

研究注册日期

首次提交

2018年9月5日

首先提交符合 QC 标准的

2018年9月7日

首次发布 (实际的)

2018年9月10日

研究记录更新

最后更新发布 (实际的)

2022年7月20日

上次提交的符合 QC 标准的更新

2022年7月19日

最后验证

2022年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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