跳至主要内容
临床试验/NCT05365269
NCT05365269已完成不适用

Proactive Automatized Lifestyle Intervention for Cancer Prevention

University Medicine Greifswald2 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2022年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
175
试验地点
2
主要终点
Intervention reach

研究概览

简要总结

Background: The co-occurrence of health risk behaviors (HRBs), namely of tobacco smoking, insufficient physical activity, unhealthy diet and at-risk alcohol use, more than doubles the risk of cancer, other chronic diseases and mortality; and applies to more than half of adult general populations. However, preventive measures that target all four HRBs and that reach the majority of the target populations and particularly those persons most in need and hard to reach (e.g. with low socio-economic status), are scarce. Electronic interventions may help to efficiently address multiple HRBs in whole populations, such as health care patients. The aim is to investigate the acceptance of a proactive and brief electronic multiple behavior change intervention among general hospital patients with regards to reach, retention, equity in reach and retention, satisfaction and subsequent trajectories of behavior change motivation, HRBs and health.

Methods: A pre-post-intervention study with four time points will be conducted at a general hospital in Germany. Patients admitted to participating medical departments (internal medicine, general surgery, trauma surgery, ear-nose-throat medicine) and aged 18-64 years will be systematically approached and invited to participate, irrespective of reason for admission and HRB profile. Based on HRB profile and on psychological behavior change theory, participants (n=175) will receive individualized computer-generated feedback concerning all four HRBs and motivation-enhancing feedback for up to two HRBs; directly on the ward and 1 and 3 months later. Intervention reach and retention will be determined by the proportion of participants among eligible patients and participants, respectively. Equity in reach and retention will be measured with regards to school education and other socio-demographics. To investigate satisfaction with the intervention and trajectories of motivational measures, HRBs and health measures, a 6-month follow-up will be conducted. Descriptive statistics, multivariate regressions and latent growth modelling will be applied.

Discussion: This study will be the first to investigate the acceptance of a proactive, electronic and brief multiple behavior change intervention among general hospital patients. If reach is high and efficacy established by a randomized controlled trial, the intervention has potential for public health impact in terms of primary and secondary prevention of diseases.

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

By nature, the participants, investigators and outcomes assessors of the single arm study are informed that an intervention is being (or has been) delivered.

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • General hospital patients admitted to participating wards of four medical departments (internal medicine, surgical medicine, trauma medicine, ear-nose-throat) at the University Medicine Hospital Greifswald in northeastern Germany

排除标准

  • Cognitively or physically incapable
  • Presence of a highly infectious disease
  • Discharge or transferral within the first 24 hours
  • Already asked for participation during previous hospital stay
  • Insufficient language skills
  • Employed at the conducting research institute
  • Neither telephone nor email

结局指标

主要结局

Intervention reach

时间窗: Month 0

Proportion of participants among all eligible patients

Intervention retention

时间窗: Month 3

Proportion of participants who continue participation 3 months after hospitalization

次要结局

  • Change in mental health(Month 0, 6)
  • Satisfaction with intervention(Month 6)
  • Change in alcohol use(Month 0, 1, 3, 6)
  • Change in general health(Month 0, 6)
  • Change in physical activity(Month 0, 1, 3, 6)
  • Change in decisional balance(Month 0, 1, 3, 6)
  • Change in diet(Month 0, 1, 3, 6)
  • Change in body-mass-index(Month 0, 6)
  • Change in stage of change(Month 0, 1, 3, 6)
  • Change in tobacco smoking(Month 0, 1, 3, 6)
  • Change in sum of behavioral health risk factors(Month 0, 1, 3, 6)
  • Change in sick days(Month 0, 6)
  • Change in self-efficacy(Month 0, 1, 3, 6)
  • Change in processes of change(Month 0, 1, 3, 6)

研究者

发起方
University Medicine Greifswald
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Proactive Automatized Lifestyle Intervention | 临床试验