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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073599', 'term': 'Health Risk Behaviors'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D004327', 'term': 'Drinking Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and enrollment staff are masked before enrollment; the outcome assessors are masked for follow-up assessment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 788}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Multiple Health Risk Behavior Index', 'timeFrame': 'month 0, 1, 3, 6, 12, 24', 'description': '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)'}, {'measure': 'Change in physical activity', 'timeFrame': 'months 0, 1, 3, 6, 12, 24', 'description': 'European Health Interview Survey-Physical Activity Questionnaire, three additional items'}, {'measure': 'Change in diet', 'timeFrame': 'months 0, 1, 3, 6, 12, 24', 'description': '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'}, {'measure': 'Change in alcohol use', 'timeFrame': 'months 0, 1, 3, 6, 12, 24', 'description': 'Alcohol Use Disorder Identification Test - Consumption; alcohol use in past month'}, {'measure': 'Change in tobacco smoking', 'timeFrame': 'months 0, 1, 3, 6, 12, 24', 'description': 'Self-reported number of cigarettes per day; smoking status'}], 'secondaryOutcomes': [{'measure': 'Change in stage of change', 'timeFrame': 'months 0, 1, 3, 6, 12, 24', 'description': 'Behavior-specific staging algorithms based on the transtheoretical model of intentional behavior change (TTM)'}, {'measure': 'Change in self-efficacy', 'timeFrame': 'months 0, 1, 3, 6, 12, 24', 'description': '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'}, {'measure': 'Change in decisional balance', 'timeFrame': 'months 0, 1, 3, 6, 12, 24', 'description': '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'}, {'measure': 'Change in processes of change', 'timeFrame': 'months 0, 1, 3, 6, 12, 24', 'description': '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'}, {'measure': 'Change in general health', 'timeFrame': 'month 0, 6, 12, 24', 'description': '1 item on self-reported health ranging between poor (0) and excellent (4)'}, {'measure': 'Change in mental health', 'timeFrame': 'months 0, 6, 12, 24', 'description': '5-item Mental Health Inventory; Higher scores indicate better mental health'}, {'measure': 'Change in sick days', 'timeFrame': 'months 0, 6, 12, 24', 'description': 'Number of self-reported sick days past 6 months'}, {'measure': 'Change in non-communicable diseases', 'timeFrame': 'months 0, 6, 12, 24', 'description': 'Self-reported cardio-vascular disease, chronic respiratory disease, cancer disease, diabetes'}, {'measure': 'Change in utilization of health care - general practitioner', 'timeFrame': 'months 0, 6, 12, 14', 'description': 'Self-reported consultation of general practitioners past 6 months (number)'}, {'measure': 'Change in utilization of health care - medical specialist', 'timeFrame': 'months 0, 6, 12, 24', 'description': 'Self-reported consultation of medical specialists past 6 months (number)'}, {'measure': 'Change in utilization of health care - physiotherapist', 'timeFrame': 'months 0, 6, 12, 24', 'description': 'Self-reported consultation of physiotherapists past 6 months (yes/no)'}, {'measure': 'Change in utilization of health care - psychologist/ psychotherapist/ psychiatrist', 'timeFrame': 'months 0, 6, 12, 24', 'description': 'Self-reported consultation of psychologist/ psychotherapist/ psychiatrist past 6 months (yes/no)'}, {'measure': 'Change in utilization of health care - inpatient', 'timeFrame': 'months 0, 6, 12, 24', 'description': 'Self-reported inpatient hospital care past 6 months (number of nights)'}, {'measure': 'Change in utilization of health care - outpatient', 'timeFrame': 'months 0, 6, 12, 24', 'description': 'Self-reported outpatient hospital care past 6 months (number of admissions)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Risk Behaviors', 'Tobacco Smoking', 'Alcohol Use', 'Unhealthy Diet, Exercise, Smoking, and Alcohol Use', 'Unhealthy Diet', 'Insufficient Physical Activity', 'Vegetable Intake']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www2.unimedizin-greifswald.de/prevention/1/research/aktuelle-forschungsprojekte/praevention-von-suchtverhalten/proactive-automatized-lifestyle-intervention/', 'label': 'ePAL Homepage'}]}, 'descriptionModule': {'briefSummary': '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.\n\nMethods: 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.\n\nDiscussion: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to participating wards of the University Medicine Hospital Greifswald on Mondays through Thursdays\n\nExclusion Criteria:\n\n* cognitively or physically incapable\n* presence of a highly infectious disease\n* discharge or transferral within the first 24 hours\n* already recruited for study during previous stay\n* insufficient German language skills\n* employed the conducting research department\n* no email and no mobile phone'}, 'identificationModule': {'nctId': 'NCT07441603', 'acronym': 'ePAL', 'briefTitle': 'Efficacy of the Proactive Automatized Lifestyle Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'Investigating the Efficacy of the Proactive Automatized Lifestyle Intervention Among General Hospital Patients', 'orgStudyIdInfo': {'id': 'D8 4700 0010'}, 'secondaryIdInfos': [{'id': '70115790', 'type': 'OTHER_GRANT', 'domain': 'Deutsche Krebshilfe (German Cancer Aid)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital multi-behavior change intervention', 'description': 'Proactive Automatized Lifestyle intervention Frequency: 3 times (month 0, 1, 3) Dosage: Individually tailored feedback corresponding to about 1-6 pages Duration: 3 months', 'interventionNames': ['Behavioral: Proactive Automatized Lifestyle intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Minimal assessment', 'description': 'Routine care and minimal assessment only'}], 'interventions': [{'name': 'Proactive Automatized Lifestyle intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Digital multi-behavior change intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jennis Freyer-Adam, Prof.', 'role': 'CONTACT', 'email': 'Jennis.Freyer-Adam@med.uni-greifswald.de', 'phone': '+49 (0)3834 867732'}, {'name': 'Anne Moehring, Dr.', 'role': 'CONTACT', 'email': 'anne.moehring@med.uni-greifswald.de', 'phone': '+49 (0)3834 867716'}]}, 'ipdSharingStatementModule': {'url': 'https://www2.unimedizin-greifswald.de/prevention/1/department/team/prof-dr-jennis-freyer-adam/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': "The data won't be publicly available due to data protection regulations in Germany.", 'ipdSharing': 'YES', 'description': 'IPD that underlie results in a publication may be shared', 'accessCriteria': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert Koch Institute Berlin', 'class': 'UNKNOWN'}, {'name': 'University Hospital Lübeck', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Jennis Freyer-Adam, PhD', 'investigatorAffiliation': 'University Medicine Greifswald'}}}}