Efficacy of the Proactive Automatized Lifestyle Intervention

NCT07441603 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 788

Last updated 2026-08-25

No results posted yet for this study

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. 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.

Conditions

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

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.

Sponsors & Collaborators

  • Robert Koch Institute Berlin

    collaborator UNKNOWN
  • University Hospital Lübeck

    collaborator OTHER
  • University Medicine Greifswald

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-25
Primary Completion
2029-06-30
Completion
2029-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07441603 on ClinicalTrials.gov