AzTrials
AzTrials

Health Risk BehaviorsPALNCT05365269

Proactive Automatized Lifestyle Intervention

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Health Risk Behaviors
What is being tested?
Proactive Automatized Lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
1 siteGermany
Study dates
31 May 2022to 24 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

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

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Medicine Greifswald

    Greifswald, Mecklenburg-Vorpommern, 17475

Other trials in Germany

About this study

Official title: Proactive Automatized Lifestyle Intervention for Cancer Prevention

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.

Being tested
Proactive Automatized Lifestyle intervention
Medical subject headings
Health Risk Behaviors

What participants receive

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

  • Proactive Automatized Lifestyle interventionBehavioural

    Multi-behavioral; including individually-tailored, theory-based, repetitive, ipsative and normative feedback.

Study groups in NCT05365269
Study groupRoleWhat they receive
Computer-generated feedback on health risk behaviorsExperimentalProactive 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

What is being measured

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

  1. Intervention reach

    Proportion of participants among all eligible patients

    Measured: Month 0

  2. Intervention retention

    Proportion of participants who continue participation 1 month after hospitalization

    Measured: Month 1

  3. Intervention retention

    Proportion of participants who continue participation 3 months after hospitalization

    Measured: Month 3

Secondary outcomes (14)

  1. Satisfaction with intervention

    Modified and adapted 29-item Multi-Dimensional Measure of Satisfaction with Behavioral Interventions; assessing process (intervention characteristic ratings, dose and format ratings, usage, overall intervention rating) and outcome (discomfort, attribution of outcomes to treatment)

    Measured: Month 6

  2. Change in physical activity

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

    Measured: Month 0, 1, 3, 6

  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) and sugar (gram) 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: Month 0, 1, 3, 6

  4. Change in alcohol use

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

    Measured: Month 0, 1, 3, 6

  5. Change in tobacco smoking

    Self-reported number of cigarettes per day; smoking status

    Measured: Month 0, 1, 3, 6

  6. Change in sum of behavioral health risk factors

    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)

    Measured: Month 0, 1, 3, 6

  7. Change in body-mass-index

    Obtained from self-reported body weight and height

    Measured: Month 0, 6

  8. Change in general health

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

    Measured: Month 0, 6

  9. Change in mental health

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

    Measured: Month 0, 6

  10. Change in sick days

    Number of self-reported sick days past 6 months

    Measured: Month 0, 6

  11. Change in stage of change

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

    Measured: Month 0, 1, 3, 6

  12. 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

    Measured: Month 0, 1, 3, 6

  13. 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

    Measured: Month 0, 1, 3, 6

  14. 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: Month 0, 1, 3, 6

Timeline

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

  1. First posted9 May 2022
  2. Study start31 May 2022
  3. Primary completion31 Mar 2023
  4. Study completion24 Apr 2023

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05365269
Sponsor's protocol ID
D8 5000 0001
Acronym
PAL
Status last verified
Jun 2023
First submitted
25 Apr 2022
Last updated
3 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD that underlie results in a publication may be shared

Publications

  • Timm C, Tiede A, Krolo-Wicovsky F, Spielmann M, Bischof G, Meyer C, John U, Freyer-Adam J. General hospital patients' satisfaction with a proactive automatized multiple health behavior change intervention. BMC Health Serv Res. 2025 Sep 23;25(1):1209. doi: 10.1186/s12913-025-13425-x.

    PubMed 40988066

  • Spielmann M, Krolo-Wicovsky F, Tiede A, John U, Freyer-Adam J. Proactive automatized multiple health risk behavior change intervention: reach and retention among general hospital patients. Eur J Public Health. 2025 Aug 1;35(4):635-641. doi: 10.1093/eurpub/ckaf035.

    PubMed 40101761

  • Timm C, Krolo-Wicovsky F, Tiede A, Spielmann M, Gaertner B, John U, Freyer-Adam J. General hospital patients' attitude towards systematic health risk behavior screening and intervention. BMC Public Health. 2024 Oct 18;24(1):2877. doi: 10.1186/s12889-024-20410-2.

    PubMed 39425090

  • 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.

    PubMed 36123081

Questions about this trial

What is this clinical trial studying?

A study testing Proactive Automatized Lifestyle intervention in people with Health Risk Behaviors, 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 7 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: finished, as of the sponsor's last update on 3 Jul 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention reach (time frame: Month 0). The study lists 3 primary outcomes in all. 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 NCT05365269, which also lists 4 linked publications.

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 3 Jul 2023.

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