An interventional study of Proactive Automatized Lifestyle intervention in Health Risk Behaviors, Tobacco Smoking and Alcohol Use, sponsored by University Medicine Greifswald. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by University Medicine Greifswald · Not applicable, Interventional, and Prevention
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.
60 studies on the registry are indexed under Health Risk Behaviors; 17 are open to participants now.
This study's planned enrollment of 788 is above the median of 144 across 47 interventional studies indexed under Health Risk Behaviors.
Browse Health Risk Behaviors studies →University Medicine Greifswald is the lead sponsor of 152 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
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
Routine care and minimal assessment only
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.
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)
Time frame: months 0, 1, 3, 6, 12, 24
Change in tobacco smoking
Self-reported number of cigarettes per day; smoking status
Time frame: months 0, 1, 3, 6, 12, 24
Change in alcohol use
Alcohol Use Disorder Identification Test - Consumption; alcohol use in past month
Time frame: 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
Time frame: months 0, 1, 3, 6, 12, 24
Change in physical activity
European Health Interview Survey-Physical Activity Questionnaire, three additional items
Time frame: months 0, 1, 3, 6, 12, 24
Change in stage of change
Behavior-specific staging algorithms based on the transtheoretical model of intentional behavior change (TTM)
Time frame: 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 reduce alcohol use / to refrain from tobacco smoking
Time frame: 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
Time frame: 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 changing physical activity / vegetable and fruit intake / tobacco use and of alcohol use
Time frame: months 0, 1, 3, 6, 12, 24
Change in body-mass-index
Time frame: months 0, 6, 12, 24
Change in general health
1 item on self-reported health ranging between poor (0) and excellent (4)
Time frame: months 0, 6, 12, 24
Change in mental health
5-item Mental Health Inventory; Higher scores indicate better mental health
Time frame: months 0, 6, 12, 24
Change in sick days
Number of self-reported sick days past 6 months
Time frame: months 0, 6, 12, 24
Change in non-communicable diseases
Self-reported cardio-vascular disease, chronic respiratory disease, cancer disease, diabetes
Time frame: months 0, 6, 12, 24
Change in utilization of health care - general practitioner
Self-reported consultation of general practitioners past 6 months (number)
Time frame: months 0, 6, 12, 14
Change in utilization of health care - medical specialist
Self-reported consultation of medical specialists past 6 months (number)
Time frame: months 0, 6, 12, 24
Change in utilization of health care - physiotherapist
Self-reported consultation of physiotherapists past 6 months (yes/no)
Time frame: 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)
Time frame: months 0, 6, 12, 24
Change in utilization of health care - inpatient
Self-reported inpatient hospital care past 6 months (number of nights)
Time frame: months 0, 6, 12, 24
Change in utilization of health care - outpatient
Self-reported outpatient hospital care past 6 months (number of admissions)
Time frame: months 0, 6, 12, 24
Change in general well-being
5-items WHO well-being Index (WHO-5); higher scale scores indicate better well-being
Time frame: months 0, 6, 12, 24
Change in satisfaction with life
Satisfaction with Life Scale 5 Items; higher scale scores indicate greater satisfaction
Time frame: months 0, 6, 12, 24
Plan to share: Yes — IPD that underlie results in a publication may be shared
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
Data sharing details ↗ · www2.unimedizin-greifswald.de
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