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临床试验/NCT05837468
NCT05837468尚未招募不适用

Better App: (Further-)Development and Evaluation of a Digital Lifestyle Programme Based on Subtypes for Overweight or Obese People

Zuyd University of Applied Sciences0 个研究点目标入组 65 人开始时间: 2023年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
65
主要终点
inter-rater reliability

研究概览

简要总结

In recent years, we developed and evaluated personalised lifestyle interventions, the BETTER programmes (BETER in Dutch, acronym for Move, Eat, Change). Underlying principle for all BETER programmes is that people with the same condition may have different underlying causes, so-called subtypes. In this follow-up project with a mixed methods design, we aim to evaluate and optimise the subtype-questionnaire/algorithm (study 1, interrater reliabiliy) and evaluate the digitised BETER programme, the BETTER App (study 2, case series design with qualitative and quantitative evaluation). The main questions it aims to answer are:

  1. What is the inter-rater reliability of two subtype experts and criterion validity of the symptom questionnaire compared with the experts for identifying overweight subtypes?
  2. How is the BETER app used and rated (process evaluation)? To answer question 1, participants complete a questionnaire and have two interviews with two experts. To answer question 2, participants use the BETTERapp for 6 weeks and complete a usability questionnaire after 3 and 6 weeks and participate in 1 or 2 focus group interviews. This study contributes to optimising the Minimal Viable Product of the BETER app to finally reach a mature version.

详细描述

Backgroud: In the Netherlands, the number of people with chronic conditions has increased significantly in recent years and is expected to continue to grow (2). Treating chronic conditions is expensive and requires a lot of care and attention. This leads to high healthcare costs for both the patient and the government. The Dutch state spent 108 billion euros on medical and long-term care in 2021, the largest part of the 125 billion euros spent on Care and Welfare in total at that time (3). Chronic conditions have a major impact on people's quality of life. They can cause symptoms and limitations in daily life and also affect people's work participation.

Overweight and obesity are related to an increased risk of many chronic conditions, such as cardiovascular disease, type 2 diabetes and certain cancers. Lifestyle plays an important role in the development of overweight and obesity. It is known that an unhealthy diet and lack of physical activity are the most common causes of overweight and obesity. Therefore, it is important to take action and offer programmes to reverse these trends and promote healthy lifestyles (4,5). In contrast to a generalised approach, more personalised interventions match a person's specific needs, characteristics and situations and can therefore potentially lead to better results when it comes to sustainable changes in healthy lifestyles (6-8).

Personalised lifestyle interventions, the BETTER programmes, have been developed and evaluated by Zuyd University of Applied Sciences' lectorate of Nutrition, Lifestyle and Exercise in recent years. BETTER stands (BETER in Dutch) for Move, Eat, Change and the programmes focus on exercise, nutrition and behavioural change. Knowledge and insights from systems biological fundamental research provide the basis for these programmes to make lifestyle recommendations more personalised. There is increasing evidence, that people with the same condition, may have different underlying causes, which also makes lifestyle recommendations and interventions different (9). In the BETTER programmes, this knowledge is practically applied by working with subtypes.

The face-to-face BETTER lifestyle programme has been successfully applied to overweight and obese individuals. After completing the programme, participants lost weight, felt fitter and indicated they felt more in control of their lifestyle (10).

Within the BETTER programme, individual subtyping of participants took place by one or more experts. This is time-consuming and (relatively) expensive, especially for repeated measurements. In a pilot study, we investigated to what extent the subtype determined by means of a digital symptom questionnaire, including algorithm, corresponds to the subtype determined by an expert (criterion validity). First preliminary results showed that the outcomes from the questionnaire corresponded moderately to reasonably well with the expert classification. Based on these data, a machine learning algorithm was developed, capable of increasing the validity of the questionnaire (optimising weightings and dependencies of answers). This algorithm can be trained by adding new data (completed questionnaire and subtyping by expert). The algorithm works on the basis of the Semi-Supervised Classification principle (11).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persons aged 16 years or older who are overweight or obese (body mass index (BMI) of 25 or higher)

排除标准

  • : Insufficient mastery of Dutch language, insufficient basic smartphone skills.

结局指标

主要结局

inter-rater reliability

时间窗: from May to December 2023

To assess inter-rater reliability between the two experts, the Cohen's kappa (k) with standard error and percentage agreement is calculated between the two experts. A 95% confidence interval is used. Both the unweighted Kappa and the linearly weighted Kappa are calculated. By means of the weighted kappa, in case of difference, it can be examined whether this difference mainly occurs between certain subtypes and can be corrected for this

criterion validity

时间窗: from May to December 2023

For determining criterion validity, the degree of agreement is expressed as a correlation coefficient (r ≥ 0.8 is assessed as 'good' and used as a cut-off point). In addition, sensitivity, specificity and F1 score are assessed using a 5x5 table and the five "One versus Rest" ROC curves

Usability

时间窗: from May to December 2023

At T1 and T2, usage, experiences and ratings are mapped through a questionnaire (mHealth App Usability Questionnaire (MAUQ)) and focus group interviews

Use

时间窗: from May to December 2023

Log files automatically record how often a person logs in, which parts of the BETER app are used by participants and the duration of app use.

次要结局

未报告次要终点

研究者

发起方
Zuyd University of Applied Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Rothgangel

PhD

Zuyd University of Applied Sciences

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