CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 175 enrolled
Drug / intervention
Proactive Automatized Lifestyle interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05365269
NCT05365269N/ACompleted

Proactive Automatized Lifestyle Intervention for Cancer Prevention

University Medicine Greifswald·interventional·Posted May 9, 2022·Updated Jul 3, 2023

In Brief

A clinical study evaluating Proactive Automatized Lifestyle intervention for Health Risk Behaviors. Completed, enrolled 175 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany

Timeline

N/ACompletedFinished
2023202420252026
First PostedMay 9, 2022
Enrollment StartMay 31, 2022
Primary CompletionMar 31, 2023
Study CompletionApr 24, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.1 years ago

Interventions

Proactive Automatized Lifestyle interventionbehavioral

Multi-behavioral; including individually-tailored, theory-based, repetitive, ipsative and normative feedback.