Effect of the WARIFA App on User-defined Objectives, Healthy Lifestyles and Management of Type 1 Diabetes: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Self-defined goal by the participants
研究概览
简要总结
The goal of this study is to assess the effect of the WARIFA app on the adoption of healthy lifestyle behaviours related to Non-communicable diseases (NCDs), as well as in the management of Type 1 Diabetes (T1D). This is done using user-generated data analysis, artificial intelligence (AI) and risk estimation to provide personalised recommendations on lifestyle-related behaviours through a mobile app.
- Primary objective: the objective of this study is to assess the impact of using the WARIFA app on a series of outcomes, related to the promotion of healthy lifestyles and prevention of NCDs, as well as on the management of T1D.
- Secondary objectives: to assess the feasibility of implementation of a complex health app (WARIFA), and to explore which outcomes are more relevant in this context for users.
The study will evaluate the app in two different populations:
- Population 1: Citizens living in Europe of either sex aged > 18 years diagnosed with no more than one NCD (of the following: CVD, any type of cancer, chronic respiratory disease and T2D) and current owners of a smartphone with internet access.
- Population 2: European adult individuals of either sex aged >18 years with T1D currently using multiple daily insulin injections or an insulin pump and current owners of a smartphone with internet access.
The study will be carried out in three centres in three different countries: the Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) in Spain, the Norwegian Centre for E-health Research (NSE) in Norway, and in Romania.
Participants in each population will be randomised to an intervention or control arm on a 1:1 ratio:
- Intervention arm: the Warifa app will be used by the participants throughout the study. The app will provide personalised risk estimations and recommendations through user-generated data analysis and artificial intelligence.
- Control arm: The control group will use a Warifa app with the same functionalities than the intervention arm, but without artificial intelligence.
At baseline, information will be collected by questionnaires and a physical examination, including anthropometry and a lipid profile. These measurements will be repeated in 12 weeks and will be compared between the treatment arms.
The study will last 3 months in total, start of recruitment on 10 February 2025, end of study after the last visit of the last participant, on 12 May 2025. Each user will participate in the study for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Common for both population groups:
- •Adults over 18 years of age.
- •Owners of a smartphone operating with Android and with internet access.
- •Group 1: General population:
- •Healthy or diagnosed with no more than one NCD (CVD, any type of cancer, T2D or chronic respiratory disease).
- •Group 2: T1D:
- •Treatment with multiple subcutaneous insulin injections or an insulin pump.
- •Users of a continuous glucose monitor.
排除标准
- •Common for both groups:
- •Pregnancy.
- •Mobile device which is incompatible with the WARIFA app (E.g. Apple devices).
- •Unable to understand any of the app languages (Spanish, English, Norwegian or Romanian).
- •Any reason which precludes follow-up, based on the researcher's criteria.
- •Group 1: General population
- •People with two or more NCDs.
研究组 & 干预措施
Use of WARIFA app with artificial intelligence (AI)
Participants will use a version of WARIFA app with artificial intelligence and personalized messages.
干预措施: WARIFA app with AI (Device)
Use of WARIFA app without artificial intelligence (AI)
Participants will use a version of WARIFA app with the same functionalities as the intervention group, but without artificial intelligence and personalized messages.
干预措施: WARIFA app without AI (Device)
结局指标
主要结局
Self-defined goal by the participants
时间窗: At the end of intervention at 12 weeks
Degree of achievement of a self-defined goal by the participants (selected among: increase consumption on fruit and vegetables, increase physical activity, reduce alcohol consumption, stop smoking, reduce number of weekly hypoglycaemic episodes, or improve sun protective behaviours). It will be measured on a Likert scale, with scores ranging from 1 ('well below expectations') to 10 ('well above expectations').
次要结局
- Hypoglycaemic events(From enrollment to the end of intervention at 12 weeks)
- Perceived quality of life(At the enrollment and the end of intervention at 12 weeks)
- Muscle mass.(At the enrollment and the end of intervention at 12 weeks)
- Usability(At the enrollment and the end of intervention at 12 weeks)
- Frequency of app use(From enrollment to the end of intervention at 12 weeks)
- Consistency in data recording(From enrollment to the end of intervention at 12 weeks)
- Changes in eating habits(From enrollment to the end of intervention at 12 weeks)
- Time in ranges(From enrollment to the end of intervention at 12 weeks)
- Total cholesterol(At the enrollment and the end of intervention at 12 weeks)
- HDL cholesterol(At the enrollment and the end of intervention at 12 weeks)
- LDL cholesterol(At the enrollment and the end of intervention at 12 weeks)
- Non-HDL cholesterol(At the enrollment and the end of intervention at 12 weeks)
- Time spent using the app(From enrollment to the end of intervention at 12 weeks)
- ABACUS scale(At the enrollment and the end of intervention at 12 weeks)
- Changes in physical activity(From enrollment to the end of intervention at 12 weeks)
- Reduction in tobacco consumption(From enrollment to the end of intervention at 12 weeks)
- Reduction in alcohol consumption(From enrollment to the end of intervention at 12 weeks)
- Changes in sun protection behaviour(From enrollment to the end of intervention at 12 weeks)
- Glycosylated haemoglobin(At the enrollment and the end of intervention at 12 weeks)
- Glucose Management Indicator(From enrollment to the end of intervention at 12 weeks)
- Average glucose(From enrollment to the end of intervention at 12 weeks)
- Fat mass(At the enrollment and the end of intervention at 12 weeks)
- Weight(At the enrollment and the end of intervention at 12 weeks)
- Height(At the enrollment)
- Circumference of abdomen.(At the enrollment and the end of intervention at 12 weeks)
- Circumference of the calf(At the enrollment and the end of intervention at 12 weeks)
- Body fat.(At the enrollment and the end of intervention at 12 weeks)
- Chair test 5 repetitions(At the enrollment and the end of intervention at 12 weeks)
- Dynamometry(At the enrollment and the end of intervention at 12 weeks)
- Acquired knowledge(At the enrollment and the end of intervention at 12 weeks)
- Self-efficacy(At the enrollment and the end of intervention at 12 weeks)
- Changes in sun protection behaviour(At the enrollment and the end of intervention at 12 weeks)
研究者
Rosa María Sánchez Hernández
MD, PhD
Complejo Hospitalario Universitario Insular Materno Infantil