The Validation of a Proof-of-concept Study of People at Risk for Diabetes With Personalised Lifestyle Interventions and E-health to Change Lifestyle Behaviour and Reverse the Risk for Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Diabetes risk based on HbA1c level (mmol/mol)
研究概览
简要总结
In the present study the investigators will examine whether people living with prediabetes benefit from an e-health lifestyle intervention of three months.
详细描述
In the Netherlands about 1,2 million people are living with type 2 diabetes. This number increases weekly by an average of 1000 people. Besides, an equal number of people are living in a condition of prediabetes. In this precondition of type 2 diabetes, prevention is still possible for people by changing their lifestyle. Ideally, for every individual a personalised lifestyle intervention, adapted to the individual situation, biology and preferences is advised. A personalised lifestyle intervention is effective in preventing and delaying progression to type 2 diabetes. In this study, it will be investigated whether it is feasible to perform a personalised lifestyle intervention in combination with an online e-health platform. The e-Health for Empowerment by Lifestyle, Food advice and Interaction (ELFI) Health lifestyle intervention aims to improve the lifestyle of people with prediabetes to prevent them from developing type 2 diabetes.
Therefore, the primary objective is to execute a feasibility study of the ELFI Health lifestyle intervention for three months in people with prediabetes in primary care (based on HbA1c). The secondary objectives are assessing the impact of the ELFI health lifestyle intervention after three months on objective outcome parameters, including lipid profile, body composition, waist and hip circumference, blood pressure, and nutritional intake, as well as evaluating the lifestyle intervention and the online e-health platform used by participants and medical professionals.
The study is a feasibility study, studying the ability of a personalised lifestyle intervention and e-health platform to change lifestyle behaviour and decrease the risk for the development of type 2 diabetes in people with prediabetes.
The participants are newly diagnosed adults with prediabetes, aged 18-70 years. Prediabetes is defined as people with disturbed glucose values based on HbA1c levels of 39 - 53 mmol/mol (= 5.7 - 7.0%).
The intervention in this study consists of a personalised lifestyle intervention for three months. After measurements of HbA1c, blood lipids, body composition, waist and hip circumferences, blood pressure, and after assessment of food intake, a personal goal is set and participants start following the personalised lifestyle intervention. This is partly a digital intervention and partly a physical intervention (blended care). The digital part is followed via an online e-health platform, which offers different information modules. The physical part consists of different measurements of the outcome parameters and community events, where participants are in contact with their general practitioner and peers. Besides, participants have three appointments during the intervention period with a dietician to discuss their personalised program.
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
盲法说明
All subjects will participate in a blended/hybrid intervention of live and online lifestyle support
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy as assessed with screening questionnaire
- •HbA1c: 39 - 53 mmol/mol (= 5.7 - 7.0%)
- •Age between 18 - 70 years
- •Stable BMI of 25 - 35 kg/m2
- •Informed consent signed
- •Willing to comply with the study procedures during the study
- •Being able to become more physically active, as assessed by the screening questionnaire (P9885 F02; in Dutch).
- •Being digitally competent
- •Willing to accept the use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
排除标准
- •Being diagnosed with diabetes type 1 or 2
- •Use of insulin, corticosteroids (systemic), or beta-blockers in past month
- •Use of oral diabetes medication in past year
- •(Having a history of a) medical condition that might significantly affect the study outcome as judged by the general practitioner and health and lifestyle questionnaire. This includes gastrointestinal dysfunction, diseases related to inflammation or allergy, or a psychiatric disorder
- •Being abroad or on vacation for longer than a week.
- •Alcohol consumption > 21 (women) - 28 (men) units/week
- •Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
- •Recent blood donation (<1 month prior to the start of the study)
- •Not willing to give up blood donation during the study
- •Not willing to accept information-transfer concerning participation in the study, or information regarding his health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
- •Pregnant or lactating women
- •Involved in another Combined Lifestyle Intervention or weight loss program
- •On GLP-1 analogues to stimulate weight loss
结局指标
主要结局
Diabetes risk based on HbA1c level (mmol/mol)
时间窗: three months
Change in HbA1c due to lifestyle intervention (in mmol/mol)
次要结局
- hip circumference (cm)(three months)
- Habitual food intake (frequencies, number and grams)(three months)
- Lipid profile (mmol/L)(three months)
- body weight (kg)(three months)
- body fat % (%)(three months)
- waist circumference (cm)(three months)