跳至主要内容
临床试验/NCT03664089
NCT03664089已完成不适用

Physical Activity Intervention for Gestational Diabetes

Sarah Keim2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Sarah Keim
入组人数
75
试验地点
2
主要终点
Weight loss

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Weight loss

时间窗: 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.

次要结局

  • Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Leptin(NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum))
  • Body Fat %(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)(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(NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum))
  • Waist-hip Ratio(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(NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum))
  • BMI(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)(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)(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(NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum))

研究者

发起方
Sarah Keim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sarah Keim

Principal Investigator

Nationwide Children's Hospital

研究点 (2)

Loading locations...

相似试验