Efficacy of the Proactive Automatized Lifestyle Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proactive Automatized Lifestyle intervention.
- Who it may be relevant to
- Registry conditions: Health Risk Behaviors, Tobacco Smoking, Alcohol Use, Unhealthy Diet, Exercise, Smoking, and Alcohol Use. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigating the Efficacy of the Proactive Automatized Lifestyle Intervention Among General Hospital Patients
Overview
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.
Interventions
- Behavioral Proactive Automatized Lifestyle intervention
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 outcome measures
- Difference in Multiple Health Risk Behavior Index [Time frame: month 0, 1, 3, 6, 12, 24]
- Difference in physical activity [Time frame: months 0, 1, 3, 6, 12, 24]
- Difference in diet [Time frame: months 0, 1, 3, 6, 12, 24]
- Difference in alcohol use [Time frame: months 0, 1, 3, 6, 12, 24]
- Difference in tobacco smoking [Time frame: months 0, 1, 3, 6, 12, 24]
Secondary outcome measures (12)
- Difference in stage of change [Time frame: months 0, 1, 3, 6, 12, 24]
- Difference in self-efficacy [Time frame: months 0, 1, 3, 6, 12, 24]
- Difference in decisional balance [Time frame: months 0, 1, 3, 6, 12, 24]
- Difference in processes of change [Time frame: months 0, 1, 3, 6, 12, 24]
- Difference in general health [Time frame: month 0, 6, 12, 24]
- Difference in mental health [Time frame: months 0, 6, 12, 24]
- Difference in sick days [Time frame: months 0, 6, 12, 24]
- Difference in non-communicable diseases [Time frame: months 0, 6, 12, 24]
- Difference in utilization of health care - general practitioner [Time frame: months 0, 6, 12, 14]
- Difference in utilization of health care - medical specialist [Time frame: months 0, 6, 12, 24]
- Difference in utilization of health care - physiotherapist [Time frame: months 0, 6, 12, 24]
- Difference in utilization of health care - psychologist/ psychotherapist/ psychiatrist [Time frame: months 0, 6, 12, 24]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Germany · 1 center
- University Medicine Hospital Greifswald — Greifswald
Identifiers
NCT: NCT07441603 · D8 4700 0010 · 70115790