Clinical trial NCT05365269: Proactive Automatized Lifestyle Intervention
Official title: Proactive Automatized Lifestyle Intervention for Cancer Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Risk Behaviors
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Deutsche Krebshilfe e.V., Bonn (Germany)
name: Robert Koch Institut
name: University Hospital Schleswig-Holstein
First posted: 2022-05-09
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Intervention reach
timeFrame: Month 0
measure: Intervention retention
timeFrame: Month 1
measure: Intervention retention
timeFrame: Month 3
Secondary outcomes:
measure: Satisfaction with intervention
timeFrame: Month 6
measure: Change in physical activity
timeFrame: Month 0, 1, 3, 6
measure: Change in diet
timeFrame: Month 0, 1, 3, 6
measure: Change in alcohol use
timeFrame: Month 0, 1, 3, 6
measure: Change in tobacco smoking
timeFrame: Month 0, 1, 3, 6
measure: Change in sum of behavioral health risk factors
timeFrame: Month 0, 1, 3, 6
measure: Change in body-mass-index
timeFrame: Month 0, 6
measure: Change in general health
timeFrame: Month 0, 6
measure: Change in mental health
timeFrame: Month 0, 6
measure: Change in sick days
timeFrame: Month 0, 6
measure: Change in stage of change
timeFrame: Month 0, 1, 3, 6
measure: Change in decisional balance
timeFrame: Month 0, 1, 3, 6
measure: Change in self-efficacy
timeFrame: Month 0, 1, 3, 6
measure: Change in processes of change
timeFrame: Month 0, 1, 3, 6
Other outcomes:
measure: Change in non-communicable diseases
timeFrame: Month 0, 6
measure: Change in utilization of health care - general practitioner
timeFrame: Month 0, 6
measure: Change in utilization of health care - medical specialist
timeFrame: Month 0, 6
measure: Change in utilization of health care - physiotherapist
timeFrame: Month 0, 6
measure: Change in utilization of health care - psychologist/ psychotherapist/ psychiatrist
timeFrame: Month 0, 6
measure: Change in utilization of health care - inpatient
timeFrame: Month 0, 6
measure: Change in utilization of health care - outpatient
timeFrame: Month 0, 6
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
state: Mecklenburg-Vorpommern
Study officials:
affiliation: University Medicine Greifswald, Institute of Medical Psychology
name: Jennis Freyer-Adam, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medicine Greifswald, Institute CM, Department of Prevention Research and Social Medicine
name: Ulrich John, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freyer-Adam J, Krolo F, Tiede A, Goeze C, Sadewasser K, Spielmann M, Krause K, John U. Proactive automatised lifestyle intervention (PAL) in general hospital patients: study protocol of a single-group trial. BMJ Open. 2022 Sep 19;12(9):e065136. doi: 10.1136/bmjopen-2022-065136.