Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07441603

Efficacy of the Proactive Automatized Lifestyle Intervention

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medicine Hospital Greifswald

Greifswald, 17495, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Difference in Multiple Health Risk Behavior Index

    Time frame: month 0, 1, 3, 6, 12, 24

    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)

  2. Difference in physical activity

    Time frame: months 0, 1, 3, 6, 12, 24

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

  3. Difference in diet

    Time frame: months 0, 1, 3, 6, 12, 24

    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

  4. Difference in alcohol use

    Time frame: months 0, 1, 3, 6, 12, 24

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

  5. Difference in tobacco smoking

    Time frame: months 0, 1, 3, 6, 12, 24

    Self-reported number of cigarettes per day; smoking status

Secondary outcomes

  1. Difference in stage of change

    Time frame: months 0, 1, 3, 6, 12, 24

    Behavior-specific staging algorithms based on the transtheoretical model of intentional behavior change (TTM)

  2. Difference in self-efficacy

    Time frame: months 0, 1, 3, 6, 12, 24

    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 reduce alcohol use / to refrain from tobacco smoking

  3. Difference in decisional balance

    Time frame: months 0, 1, 3, 6, 12, 24

    Behavior-specific decisional balance questionnaires based on the TTM; higher scores indicate more pros and cons of changing physical activity / vegetable and fruit intake / tobacco use and of alcohol use

  4. Difference in processes of change

    Time frame: months 0, 1, 3, 6, 12, 24

    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

  5. Difference in general health

    Time frame: month 0, 6, 12, 24

    1 item on self-reported health ranging between poor (0) and excellent (4)

  6. Difference in mental health

    Time frame: months 0, 6, 12, 24

    5-item Mental Health Inventory; Higher scores indicate better mental health

  7. Difference in sick days

    Time frame: months 0, 6, 12, 24

    Number of self-reported sick days past 6 months

  8. Difference in non-communicable diseases

    Time frame: months 0, 6, 12, 24

    Self-reported cardio-vascular disease, chronic respiratory disease, cancer disease, diabetes

  9. Difference in utilization of health care - general practitioner

    Time frame: months 0, 6, 12, 14

    Self-reported consultation of general practitioners past 6 months (number)

  10. Difference in utilization of health care - medical specialist

    Time frame: months 0, 6, 12, 24

    Self-reported consultation of medical specialists past 6 months (number)

  11. Difference in utilization of health care - physiotherapist

    Time frame: months 0, 6, 12, 24

    Self-reported consultation of physiotherapists past 6 months (yes/no)

  12. Difference in utilization of health care - psychologist/ psychotherapist/ psychiatrist

    Time frame: months 0, 6, 12, 24

    Self-reported consultation of psychologist/ psychotherapist/ psychiatrist past 6 months (yes/no)

  13. Difference in utilization of health care - inpatient

    Time frame: months 0, 6, 12, 24

    Self-reported inpatient hospital care past 6 months (number of nights)

  14. Difference in utilization of health care - outpatient

    Time frame: months 0, 6, 12, 24

    Self-reported outpatient hospital care past 6 months (number of admissions)

  15. Difference in general well-being

    Time frame: months 0, 6, 12, 24

    5-items WHO well-being Index (WHO-5); higher scale scores indicate better well-being

  16. Difference in satisfaction with life

    Time frame: months 0, 6, 12, 24

    Satisfaction with Life Scale 5 Items; higher scale scores indicate greater satisfaction

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Moehring, Dr.

CONTACT

[email protected]

+49 (0)3834 867716

Jennis Freyer-Adam, Prof.

CONTACT

[email protected]

+49 (0)3834 867732

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • Robert Koch Institute Berlin
  • University Hospital Lübeck

Registry information

Official study title

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

Acronym: ePAL

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.