Efficacy of the Proactive Automatized Lifestyle Intervention (ePAL)

Investigating the Efficacy of the Proactive Automatized Lifestyle Intervention Among General Hospital Patients

Background: Individual brief behavior change interventions often do not sufficiently address the common co-occurrence of multiple health risk behaviors among people. In addition, many interventions often fail to reach the majority of the target population and particularly those people who need them the most. To address these core challenges of individual prevention research, the "Proactive Automatised Lifestyle intervention (PAL)" was developed, a proactive screening and brief intervention driven by psychological health behavior change theory to motivate participants for behavior change. The trial ePAL aims to investigate the efficacy of the multi-behavior change intervention adressing tobacco smoking, alcohol use, diet and physical activity among general hospital patients over 2 years; and to investigate differential efficacy in different subgroups of patients.

Methods: All patients admitted to non-intensive care wards on five medical departments within the University Medicine Hospital Greifswald (internal medicine A & B, surgery, trauma surgery, ear-nose-throat) and aged 18 to 64 years are systematically approached by study assistants and asked to first participate in a survey and then in the randomizd controlled trial, irrespective of their reason of admission. A total of 788 participants is allocated to two study groups. The intervention group receives individualized feedback on all four health risk behaviors to enhance motivation to change identified health risk behaviors. The feedback is driven by psychological behavior change theory, tailored to the participants' current stages of change and delivered after baseline and at months 1 and 3. The control group receives routine care and minimal assessment only. Follow-ups are conducted at months 6, 12 and 24 after baseline; and more are planned for. Efficacy will be measured concerning self-reported change in health risk behaviors, health and motivation to change measures using latent growth curve modelling.

Discussion: The trial will provide information on the efficacy of a population-based and individually tailored brief intervention to systematically provide individualized feedback to each patient for a healthy living. When found to be effective and implemented widely, such interventions may contribute to the prevention of widespread non-communicable diseases.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Smoking; Alcohol Use; Health Risk Behaviors; Unhealthy Diet; Vegetable Intake; Unhealthy Diet, Exercise, Smoking, and Alcohol Use; Insufficient Physical Activity
• Intervention / Treatment: Behavioral: Proactive Automatized Lifestyle intervention

• Study Type: Interventional
• Enrollment (Estimated): 788
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennis Freyer-Adam, Prof.; Phone Number: +49 (0)3834 867732; Email: Jennis.Freyer-Adam@med.uni-greifswald.de
• Study Contact Backup: Name: Anne Moehring, Dr.; Phone Number: +49 (0)3834 867716; Email: anne.moehring@med.uni-greifswald.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Admitted to participating wards of the University Medicine Hospital Greifswald on Mondays through Thursdays

Exclusion Criteria:

• cognitively or physically incapable
• presence of a highly infectious disease
• discharge or transferral within the first 24 hours
• already recruited for study during previous stay
• insufficient German language skills
• employed the conducting research department
• no email and no mobile phone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital multi-behavior change intervention; Proactive Automatized Lifestyle intervention Frequency: 3 times (month 0, 1, 3) Dosage: Individually tailored feedback corresponding to about 1-6 pages Duration: 3 months	Behavioral: Proactive Automatized Lifestyle intervention; addresses tobacco smoking, alcohol use, unhealthy diet and insufficient physical activity, individually-tailored, theory-driven, repetitive with three intervention contacts, normative and ipsative feedback, online feedback.
No Intervention: Minimal assessment; Routine care and minimal assessment only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Multiple Health Risk Behavior Index	Behavioral health risk factors are determined when recommendations (WHO, World Cancer Research Fund, German Center of Addiction Issues) are not met; with the total sum score ranging between 0 and 4 behavioral health risk factors (insufficient physical activity, unhealthy diet, at-risk alcohol use, tobacco smoking)	month 0, 1, 3, 6, 12, 24
Change in physical activity	European Health Interview Survey-Physical Activity Questionnaire, three additional items	months 0, 1, 3, 6, 12, 24
Change in diet	Self-reported number of servings of vegetable and fruit per day; Self-reported intake of fat (gram, kilojoule, kilocalories), fiber (gram), salt (gram), sugar (gram), processed meat per day measured by a 16 item diet screener on the number of servings of vegetable, fruit, other food rich in fiber, sweets, added sugar, sweetened drinks, cheese, convenience food, salted snacks, eggs, fatty fish, red meat, processed meat, butter/ oil, milk and bread per day/ week	months 0, 1, 3, 6, 12, 24
Change in alcohol use	Alcohol Use Disorder Identification Test - Consumption; alcohol use in past month	months 0, 1, 3, 6, 12, 24
Change in tobacco smoking	Self-reported number of cigarettes per day; smoking status	months 0, 1, 3, 6, 12, 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in stage of change	Behavior-specific staging algorithms based on the transtheoretical model of intentional behavior change (TTM)	months 0, 1, 3, 6, 12, 24
Change in self-efficacy	Behavior-specific self-efficacy questionnaires based on the TTM; higher scores indicate higher self-efficacy to be physically active / to eat vegetable and fruit / to adhere to alcohol use limits / to refrain from tobacco smoking	months 0, 1, 3, 6, 12, 24
Change in decisional balance	Behavior-specific decisional balance questionnaires based on the TTM; higher scores indicate more pros and cons of physical activity / vegetable and fruit intake / alcohol use / tobacco smoking	months 0, 1, 3, 6, 12, 24
Change in processes of change	Behavior-specific processes of change questionnaires based on the TTM; higher scores indicate higher process use in terms of increasing physical activity / eating more vegetable and fruit a day / reducing (or quitting) alcohol use / reducing (or quitting) tobacco smoking	months 0, 1, 3, 6, 12, 24
Change in general health	1 item on self-reported health ranging between poor (0) and excellent (4)	month 0, 6, 12, 24
Change in mental health	5-item Mental Health Inventory; Higher scores indicate better mental health	months 0, 6, 12, 24
Change in sick days	Number of self-reported sick days past 6 months	months 0, 6, 12, 24
Change in non-communicable diseases	Self-reported cardio-vascular disease, chronic respiratory disease, cancer disease, diabetes	months 0, 6, 12, 24
Change in utilization of health care - general practitioner	Self-reported consultation of general practitioners past 6 months (number)	months 0, 6, 12, 14
Change in utilization of health care - medical specialist	Self-reported consultation of medical specialists past 6 months (number)	months 0, 6, 12, 24
Change in utilization of health care - physiotherapist	Self-reported consultation of physiotherapists past 6 months (yes/no)	months 0, 6, 12, 24
Change in utilization of health care - psychologist/ psychotherapist/ psychiatrist	Self-reported consultation of psychologist/ psychotherapist/ psychiatrist past 6 months (yes/no)	months 0, 6, 12, 24
Change in utilization of health care - inpatient	Self-reported inpatient hospital care past 6 months (number of nights)	months 0, 6, 12, 24
Change in utilization of health care - outpatient	Self-reported outpatient hospital care past 6 months (number of admissions)	months 0, 6, 12, 24

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Collaborators: University Hospital Lübeck; Robert Koch Institute Berlin

Publications and helpful links

Helpful Links

• ePAL Homepage

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Behavior; Health Behavior; Tobacco Use; Alcohol Drinking; Motor Activity; Smoking; Tobacco Smoking; Health Risk Behaviors
• Other Study ID Numbers: D8 4700 0010; 70115790 (Other Grant/Funding Number: Deutsche Krebshilfe (German Cancer Aid))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that underlie results in a publication may be shared
• IPD Sharing Time Frame: The data won't be publicly available due to data protection regulations in Germany.
• IPD Sharing Access Criteria: Aggregated data may be made available on reasonable request that complies with the study purpose, the participants' informed consent and the German data protection lay. The request will be reviewed by the principle investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No