Diet, Exercise and Breastfeeding Intervention (DEBI) Program for Women With Gestational Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 10
- 主要终点
- Postpartum weight retention
研究概览
简要总结
The primary aim of this study is to evaluate whether a lifestyle intervention of diet, exercise, and breastfeeding is associated with decreased postpartum weight retention and reduced plasma glucose levels, measured at 6-weeks and 1-year postpartum, among women with gestational diabetes mellitus (GDM). Secondary outcomes are postpartum levels of plasma insulin, markers of insulin resistance, adiponectin, dietary fat, physical activity, and breastfeeding duration.
详细描述
Postpartum predictors of type 2 diabetes incidence in women with GDM are pregnancy weight retention and postpartum weight gain. By promoting physical activity and appropriate diet during pregnancy and soon after delivery, and preventing excessive pregnancy weight gain and postpartum weight retention, the postpartum incidence of obesity and type 2 diabetes might be reduced or delayed in GDM women. We are implementing and evaluating a lifestyle intervention of diet, physical activity, and breastfeeding among women with GDM. The diet and physical activity elements of the intervention are similar to the DPP-Follow-up study. All participants have GDM by plasma glucose levels measured during a standard 100-g, 3-h OGTT according to the ADA and the ACOG criteria and have no contraindications to participating in a diet and physical activity program. At study entry, eligible women are randomly assigned to life-style intervention or usual medical care. The intervention starts during pregnancy and continues for one year postpartum. It consists of structured, individually tailored, in-person sessions and telephone calls with a lactation consultant and a life-style coach. The goals of the intervention during pregnancy are to help GDM women comply with the Institute of Medicine guidelines for weight gain by following the ADA and ACOG recommendations for physical activity and diet. After pregnancy, the goals of the intervention are to help women exclusively breastfeed for at least six months and reach their pre-pregnancy weight. For those women who were overweight or obese prior to pregnancy, the additional goal of a reduction in weight of at least 5% of their pre-pregnancy weight is also set. For the maintenance phase of the intervention, beginning at 8 months postpartum, the intervention women receive tailored written materials in the mail and telephone calls reinforcing the positive changes they have adopted. All participants have follow-up clinic visits at 8-week, 8-month, 12-month, 18-month, and 24-month after delivery. Data analyses will be by intent-to-treat. Demographics, psychosocial and behavioral factors that may be related to success at achieving the postpartum weight goals and the secondary postpartum outcomes will be examined.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Gestational Diabetes Mellitus
排除标准
- •Ever diagnosed with diabetes when not pregnant
- •Ever diagnosed with cardiovascular disease
- •Ever diagnosed with lung disease
- •Hemoglobin < 9.5 mg/dl
- •Hematocrit less than 30%
- •SBP >= 140 or DBP >= 90 in the last month
- •Diagnosis of thyroid disease in the last month
结局指标
主要结局
Postpartum weight retention
时间窗: no more than 1.5 years
次要结局
- dietary fat(no more than 1.5 years)
- adiponectin(1 year)
- reduced plasma glucose levels (measured at 6 weeks and 1 year postpartum)(1 year)
- levels of plasma insulin(1 year)
- markers of insulin resistance(1 year)
- physical activity(no more than 1.5 years)
- breastfeeding duration(no more than 1.5 years)
