Mobile-based Lifestyle Intervention in Women With Glucose Intolerance After Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 14
- 主要终点
- weight-loss goal
研究概览
简要总结
Although lifestyle modification programs have been shown to be effective in preventing diabetes in older populations, interventions in women with recent gestational diabetes (GDM) clearly need to be adapted to address their unique barriers to behavior change in order to optimize adherence. The low participating rates in many studies using individual or group sessions, reflect how difficult it is to engage women in the first years postpartum. Since women with glucose intolerance (prediabetes) have the highest risk to develop type 2 diabetes (T2DM), we designed the MELINDA pilot study, a randomized controlled trial with 1 year of follow-up to evaluate the efficacy and feasibility of a telephone -and mobile (app) based lifestyle coaching intervention in women with glucose intolerance after a recent history of GDM to promote a healthy lifestyle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 否
入选标准
- •aged 18 or older
- •GDM based on the 2013 WHO criteria
- •glucose intolerance (prediabetes based on the ADA criteria) based on the 75g OGTT 6-16 weeks after delivery
排除标准
- •diabetes;
- •current use of metformin;
- •normal glucose tolerance (ADA criteria);
- •health limitations or treatments which would restrict the participation in the intervention trial.
- •Has no smartphone
结局指标
主要结局
weight-loss goal
时间窗: 1 year
reaching the weight-loss goal ≥5% of body weight when overweight or obese or returning to pre-gravid weight if normal BMI
次要结局
- dietary quality(1 year)
- diabetes(1 year)
- metabolic syndrome(6-16 weeks postpartum)
- duration breastfeeding(1 year)
- rate exclusive breastfeeding(1 year)
- depression(1 year)
- prediabetes(1 year postpartum)
- insulin resistance HOMA-IR(1 year)
- beta-cell function ISSI-2 index(1 year)
- beta-cell function insulinogenic index(1 year)
- insulin resistance Matsuda(1 year)
- beta-cell function HOMA-B(1 year)
- weight loss(1 year)
- quality of life(1 year)
- anxiety(1 year)
- motivation for behavior change(1 year)
- physical activity IPAQ(1 year)
- diabetes risk perception(1 year)
- physical activity pedometer(1 year)
- Sence of Coherence(1 year)