Lifestyle Intervention for Women With Recent Pre-eclampsia or Gestational Diabetes Mellitus: A Pilot Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Adherence
研究概览
简要总结
The aim of this pilot intervention study is to develop and test a tailored web-based lifestyle modification program for women with recent preeclampsia or gestational diabetes. Women will start the study 3-15 months postpartum. After obtaining written informed consent and confirmation of eligibility criteria, eligible women will be included in the pilot study using a single arm study design (all women will be assigned to the lifestyle intervention program). Participants will be provided access to a web-based lifestyle intervention program with personalized coaching from a registered dietician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Diagnosis of preeclampsia or gestational diabetes in recent pregnancy, confirmed by medical record review
- •capable to speak and read Norwegian
- •access to internet enabled mobile devices that use either iOS or Android operating systems
排除标准
- •Diagnosis of chronic hypertension or diabetes mellitus
- •current use of blood pressure lowering medication
- •medication known to affect glucose tolerance
- •active self-reported eating disorder
- •history of heart disease, stroke or kidney disease
- •history of gastric bypass or bowel surgery resulting in malabsorption
- •active medical problems that would interfere with following the diet, or with changes in blood pressure and/or weight
结局指标
主要结局
Adherence
时间窗: 6 months
Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)
Recruitment
时间窗: baseline
Proportion of eligible patients enrolled in the study
Retention
时间窗: 6 months
Proportion of participants kept in the study
次要结局
- Changes in physical activity levels(baseline, 6 months)
- Changes in total cholesterol(Baseline, 6 months)
- Changes in HbA1c(Baseline, 6 months)
- Changes in body weight(Baseline, 6 months)
- Adherence to Norwegian food-based dietary guidelines(6 months)
- Changes in blood pressure(Baseline, 6 months)