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AzTrials

Health Risk BehaviorsePALNCT07441603

Efficacy of the Proactive Automatized Lifestyle Intervention

A study testing Proactive Automatized Lifestyle intervention in people with Health Risk Behaviors and Tobacco Smoking, run by University Medicine Greifswald at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
What is being tested?
Proactive Automatized Lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
788 participants
Where
1 siteGermany
Study dates
25 Jun 2026to Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Germany1 site, 1 recruiting

  • University Medicine Hospital Greifswald

    Greifswald, 17495

    Recruiting

Other trials in Germany

About this study

Official title: 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.

Being tested
Proactive Automatized Lifestyle intervention
Medical subject headings
Health Risk Behaviors, Tobacco Smoking, Alcohol Drinking, Motor Activity, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proactive Automatized Lifestyle interventionBehavioural

    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.

Study groups in NCT07441603
Study groupRoleWhat they receive
Digital multi-behavior change interventionExperimentalProactive Automatized Lifestyle intervention Frequency: 3 times (month 0, 1, 3) Dosage: Individually tailored feedback corresponding to about 1-6 pages Duration: 3 months
Receives: Behavioral: Proactive Automatized Lifestyle intervention
Minimal assessmentNo interventionRoutine care and minimal assessment only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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, alcohol use, tobacco smoking)

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

Secondary outcomes (21)

  1. Change in tobacco smoking

    Self-reported number of cigarettes per day; smoking status

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

  2. Change in alcohol use

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

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

  3. 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

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

  4. Change in physical activity

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

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

  5. Change in stage of change

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

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

  6. 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 reduce alcohol use / to refrain from tobacco smoking

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

  7. 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

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

  8. Change in decisional balance

    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

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

  9. Change in body-mass-index

    Measured: months 0, 6, 12, 24

  10. Change in general health

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

    Measured: months 0, 6, 12, 24

  11. Change in mental health

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

    Measured: months 0, 6, 12, 24

  12. Change in sick days

    Number of self-reported sick days past 6 months

    Measured: months 0, 6, 12, 24

  13. Change in non-communicable diseases

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

    Measured: months 0, 6, 12, 24

  14. Change in utilization of health care - general practitioner

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

    Measured: months 0, 6, 12, 14

  15. Change in utilization of health care - medical specialist

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

    Measured: months 0, 6, 12, 24

  16. Change in utilization of health care - physiotherapist

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

    Measured: months 0, 6, 12, 24

  17. Change in utilization of health care - psychologist/ psychotherapist/ psychiatrist

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

    Measured: months 0, 6, 12, 24

  18. Change in utilization of health care - inpatient

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

    Measured: months 0, 6, 12, 24

  19. Change in utilization of health care - outpatient

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

    Measured: months 0, 6, 12, 24

  20. Change in general well-being

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

    Measured: months 0, 6, 12, 24

  21. Change in satisfaction with life

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

    Measured: months 0, 6, 12, 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2026
  2. Study start25 Jun 2026
  3. Primary completionJun 2029 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
788 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07441603
Sponsor's protocol ID
D8 4700 0010
Other IDs
70115790
Acronym
ePAL
Status last verified
Aug 2026
First submitted
12 Feb 2026
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD that underlie results in a publication may be shared

Questions about this trial

What is this clinical trial studying?

A study testing Proactive Automatized Lifestyle intervention in people with Health Risk Behaviors and Tobacco Smoking, run by University Medicine Greifswald at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennis Freyer-Adam, Prof. (+49 (0)3834 867732, Jennis.Freyer-Adam@med.uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Multiple Health Risk Behavior Index (time frame: months 0, 1, 3, 6, 12, 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07441603.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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