Efficacy of the Proactive Automatized Lifestyle Intervention

NCT07441603 | Recruiting DMC

• 2 other identifiers: D8 4700 001070115790
• Study Type: interventional
• Target: 788
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Risk Behaviors; Tobacco Smoking; Alcohol Use; Unhealthy Diet; Insufficient Physical Activity; Vegetable Intake; Unhealthy Diet, Exercise, Smoking, and Alcohol Use

Outcome Measures

Primary Outcomes (5)

• Difference 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, alcohol use, tobacco smoking)

  month 0, 1, 3, 6, 12, 24

• Difference in physical activity

  European Health Interview Survey-Physical Activity Questionnaire, three additional items

  months 0, 1, 3, 6, 12, 24

• Difference 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

• Difference in alcohol use

  Alcohol Use Disorder Identification Test - Consumption; alcohol use in past month

  months 0, 1, 3, 6, 12, 24

• Difference in tobacco smoking

  Self-reported number of cigarettes per day; smoking status

  months 0, 1, 3, 6, 12, 24

Secondary Outcomes (16)

• Difference in stage of change

  months 0, 1, 3, 6, 12, 24

• Difference in self-efficacy

  months 0, 1, 3, 6, 12, 24

• Difference in decisional balance

  months 0, 1, 3, 6, 12, 24

• Difference in processes of change

  months 0, 1, 3, 6, 12, 24

• Difference in general health

  month 0, 6, 12, 24

Study Arms (2)

Digital multi-behavior change intervention

EXPERIMENTAL

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

Minimal assessment

NO INTERVENTION

Routine care and minimal assessment only

Interventions

Proactive Automatized Lifestyle intervention BEHAVIORAL

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.

Digital multi-behavior change intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• cognitively or physically incapable
• presence of a highly infectious disease
• discharged or transferred within the first 24 hours
• already recruited for study during previous stay
• insufficient German language skills
• employed the conducting research department
• accompanying persons
• no email address (and no phone number)

Sponsors & Collaborators

• University Medicine Greifswald: lead
• Robert Koch Institute Berlin: collaborator
• University Hospital Lübeck: collaborator

Study Sites (1)

University Medicine Hospital Greifswald

Greifswald, 17495, Germany

RECRUITING

Related Links

• ePAL Homepage

MeSH Terms

Conditions

Health Risk Behaviors; Tobacco Smoking; Alcohol Drinking; Motor Activity; Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Use; Drinking Behavior

Central Study Contacts

Jennis Freyer-Adam, Prof.

CONTACT

+49 (0)3834 867732; Jennis.Freyer-Adam@med.uni-greifswald.de

Anne Moehring, Dr.

CONTACT

+49 (0)3834 867716; anne.moehring@med.uni-greifswald.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and enrollment staff are masked before enrollment; the outcome assessors are masked for follow-up assessment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: March 2, 2026
• Study Start: June 25, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data won't be publicly available due to data protection regulations in Germany.
• 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.

Locations

DE (1)