Efficacy of the Proactive Automatized Lifestyle Intervention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniversity Medicine Greifswald

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admitted to participating wards of the University Medicine Hospital Greifswald on Mondays through Thursdays

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Proactive Automatized Lifestyle intervention

    Behavioral

    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.

Treatment groups

788 Participants
are divided into 2 treatment groups
Group A: Digital multi-behavior change interventionExperimental treatment 1 intervention
Group B: Minimal assessmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Change in tobacco smoking

Self-reported number of cigarettes per day; smoking status

Time frame
months 0, 1, 3, 6, 12, 24
2

Change in alcohol use

Alcohol Use Disorder Identification Test - Consumption; alcohol use in past month

Time frame
months 0, 1, 3, 6, 12, 24
3

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
4

Change in physical activity

European Health Interview Survey-Physical Activity Questionnaire, three additional items

Time frame
months 0, 1, 3, 6, 12, 24

Other outcomes

Sponsors and contacts

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University Medicine Greifswald

Lead sponsor

Robert Koch Institute Berlin

Collaborator

University Hospital Lübeck

Collaborator