Effects of a 9-months Nurse-led Telephone Personalized Lifestyle Intervention Versus Automated SMSs on Nutritional and Physical Activity Advice on Glucose Profile in Patients With Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Change in fasting plasma glucose
研究概览
简要总结
A randomized, 9-months, parallel-group study comparing the effectiveness of a nurse-led telephone personalized lifestyle intervention versus automated SMSs on nutritional and physical activity advice in the reduction of fasting blood glucose and/or HbA1c in a population with prediabetes.
详细描述
It is estimated that about 70% of the prediabetic population will eventually develop type 2 diabetes (T2DM), contributing to the significant economic burden on health systems and societies. When prediabetes is recognized, lifestyle intervention including weight loss through diet and exercise can reduce the relative risk of developing T2DM by more than 50% within 3 years. In the context of the current pandemic caused by COVID-19 the implementation of prevention strategies is heavily affected. Telemedicine consultations give patients the opportunity to receive personalized advice on disease prevention even in times of pandemic. Previous studies on telemedicine intervention strategies for the prevention of T2DM show that there is a need to further explore the utility of telemedicine and especially telephone-based personalized behavioural interventions in patients with prediabetes.The aim of the present research is to determine whether a nurse-led personalized telephone lifestyle intervention is effective in reducing risk factors associated with the development of T2DM in subjects with prediabetes, versus automated short message service (SMS).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fasting plasma glucose between 100 and 125 mg/dL OR HbA1c between 5.7 and 6.4%
- •BMI ≥ 27 and < 40 kg/m2
- •Written informed consent
排除标准
- •Documented history of T2DM or use of oral antidiabetic medication
- •Terminal illness
- •Institutionalization, dementia or cognitive impairment
- •Pregnancy
- •Major surgery or hospital stay during the previous 3 months
- •Documented history of hematologic disease which may interfere with the HbA1c measurement
- •Presence of any medical or psychological condition that may limit the ability of the patient to participate in the study
- •Concomitant active participation in another clinical trial
结局指标
主要结局
Change in fasting plasma glucose
时间窗: at baseline, 4, 9, and 15 months
Change in fasting plasma glucose at 4, 9, and 15 months versus baseline
次要结局
- Blood levels of HbA1c(at baseline, 4, 9, and 15 months)
- Maintenance of acquired dietary and physical activity changes(15 month)
研究者
Josep1
PhD
University of the Balearic Islands