NL-OMON56477招募中不适用
A feasibility study for an e-health blended personalised lifestyle intervention to change lifestyle behaviour and reverse the risk for type 2 diabetes in people with prediabetes. - ELFI Health (Empowerment by Lifestyle, Food advice and Interaction)
TNO0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •To be eligible to participate in this study, a subject must meet all the
- •following criteria:
- •1. During the information session, health is assessed by the:
- •a. Screening questionnaire (P9885 F02; in Dutch)
- •2. During the health check, blood measurements are assessed by the
- •point-of-care tool:
- •a. HbA1c: 39 - 53 mmol/mol (= 5.7 - 7.0%)
- •3. Age between 18 - 70 years
- •4. Stable BMI of 25 - 35 kg/m2
- •5. Informed consent signed
- •6. Willing to comply with the study procedures during the study
- •7. Being able to become more physically active, as assessed by the screening
- •questionnaire (P9885 F02; in Dutch).
- •8. Being digitally competent
- •9. 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
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •1. Being diagnosed with diabetes type 1 or 2
- •2. Use of insulin, corticosteroids (systemic), or beta-blockers in past month
- •3. Use of oral diabetes medication in past year
- •4. (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
- •5. Being abroad or on vacation for longer than a week.
- •6. Alcohol consumption > 21 (women) - 28 (men) units/week
- •7. Reported unexplained weight loss or gain of > 2 kg in the month prior to the
- •pre-study screening
- •8. Recent blood donation (<1 month prior to the start of the study)
- •9. Not willing to give up blood donation during the study
- •10. 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.
- •11. Pregnant or lactating women
- •12. Involved in another GLI or weight loss program
- •13. On GLP-1 analogues to stimulate weight loss
研究者
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