Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-04-05 @ 5:17 AM
Study NCT ID:
NCT07441603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of the Proactive Automatized Lifestyle Intervention
Sponsor:
University Medicine Greifswald
Organization:
Study Overview
Official Title:
Investigating the Efficacy of the Proactive Automatized Lifestyle Intervention Among General Hospital Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ePAL
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 70115790 | OTHER_GRANT | Deutsche Krebshilfe (German Cancer Aid) | View |