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临床试验/NCT01809431
NCT01809431已完成不适用

Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
fasting blood glucose

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •They have a A1c ≥ 6.5 mg/dL (Type 2 diabetes)

研究组 & 干预措施

intervention

Experimental

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.

干预措施: Intervention (Behavioral)

Wait-listed control group

No Intervention

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

结局指标

主要结局

fasting blood glucose

时间窗: Baseline to 10 months postpartum

Change in fasting blood glucose in mothers

weight (body mass index)

时间窗: Baseline to 10 months postpartum

Change in weight (body mass index)in mothers

次要结局

  • self-efficacy(Baseline to 10 months postpartum)
  • homeostasis model assessment(Baseline to 10 months postpartum)
  • blood pressure(Baseline to 10 months postpartum)
  • infant weight status(Birth to 10 months)
  • hemoglobin A1c(Baseline to 10 months postpartum)
  • oral glucose tolerance test(Baseline to 10 months postpartum)
  • insulin levels(Baseline to 10 months postpartum)
  • adiposity(Baseline to 10 months)
  • complete lipid panel(Baseline to 10 months postpartum)
  • health behaviors(Baseline to 10 months postpartum)
  • breastfeeding(Birth to 10 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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