Efficacy of the Proactive Automatized Lifestyle Intervention

N/ANot Yet RecruitingNCT07441603

University Medicine Greifswald788 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Outcomes

Primary Outcomes

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, at-risk alcohol use, tobacco smoking)

Time frame: month 0, 1, 3, 6, 12, 24

Change in physical activity

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

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

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

Change in alcohol use

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

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

Change in tobacco smoking

Self-reported number of cigarettes per day; smoking status

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

Secondary Outcomes

Change in stage of change

Behavior-specific staging algorithms based on the transtheoretical model of intentional behavior change (TTM)

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

Change in self-efficacy

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

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

Change in decisional balance

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

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

Change in processes of change

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

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

Change in general health

1 item on self-reported health ranging between poor (0) and excellent (4)

Time frame: month 0, 6, 12, 24

Change in mental health

5-item Mental Health Inventory; Higher scores indicate better mental health