Proactive Automatized Lifestyle Intervention
- Conditions
- Health Risk Behaviors
- Interventions
- Behavioral: Proactive Automatized Lifestyle intervention
- Registration Number
- NCT05365269
- Lead Sponsor
- University Medicine Greifswald
- Brief Summary
Background: The co-occurrence of health risk behaviors (HRBs), namely of tobacco smoking, insufficient physical activity, unhealthy diet and at-risk alcohol use, more than doubles the risk of cancer, other chronic diseases and mortality; and applies to more than half of adult general populations. However, preventive measures that target all four HRBs and that reach the majority of the target populations and particularly those persons most in need and hard to reach (e.g. with low socio-economic status), are scarce. Electronic interventions may help to efficiently address multiple HRBs in whole populations, such as health care patients. The aim is to investigate the acceptance of a proactive and brief electronic multiple behavior change intervention among general hospital patients with regards to reach, retention, equity in reach and retention, satisfaction and subsequent trajectories of behavior change motivation, HRBs and health.
Methods: A pre-post-intervention study with four time points will be conducted at a general hospital in Germany. Patients admitted to participating medical departments (internal medicine, general surgery, trauma surgery, ear-nose-throat medicine) and aged 18-64 years will be systematically approached and invited to participate, irrespective of reason for admission and HRB profile. Based on HRB profile and on psychological behavior change theory, participants (n=175) will receive individualized computer-generated feedback concerning all four HRBs and motivation-enhancing feedback for up to two HRBs; directly on the ward and 1 and 3 months later. Intervention reach and retention will be determined by the proportion of participants among eligible patients and participants, respectively. Equity in reach and retention will be measured with regards to school education and other socio-demographics. To investigate satisfaction with the intervention and trajectories of motivational measures, HRBs and health measures, a 6-month follow-up will be conducted. Descriptive statistics, multivariate regressions and latent growth modelling will be applied.
Discussion: This study will be the first to investigate the acceptance of a proactive, electronic and brief multiple behavior change intervention among general hospital patients. If reach is high and efficacy established by a randomized controlled trial, the intervention has potential for public health impact in terms of primary and secondary prevention of diseases.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
- General hospital patients admitted to participating wards of four medical departments (internal medicine, surgical medicine, trauma medicine, ear-nose-throat) at the University Medicine Hospital Greifswald in northeastern Germany
- Cognitively or physically incapable
- Presence of a highly infectious disease
- Discharge or transferral within the first 24 hours
- Already asked for participation during previous hospital stay
- Insufficient language skills
- Employed at the conducting research institute
- Neither telephone nor email
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Computer-generated feedback on health risk behaviors Proactive Automatized Lifestyle intervention Proactive Automatized Lifestyle intervention Frequency: 3 times (month 0, 1, 3) Dosage: Individually tailored feedback corresponding to about 1-6 pages Duration: 3 months
- Primary Outcome Measures
Name Time Method Intervention reach Month 0 Proportion of participants among all eligible patients
Intervention retention Month 3 Proportion of participants who continue participation 3 months after hospitalization
- Secondary Outcome Measures
Name Time Method Change in tobacco smoking Month 0, 1, 3, 6 Self-reported number of cigarettes per day; smoking status
Change in mental health Month 0, 6 5-item Mental Health Inventory; Higher scores indicate better mental health
Satisfaction with intervention Month 6 Modified and adapted 29-item Multi-Dimensional Measure of Satisfaction with Behavioral Interventions; assessing process (intervention characteristic ratings, dose and format ratings, usage, overall intervention rating) and outcome (discomfort, attribution of outcomes to treatment)
Change in alcohol use Month 0, 1, 3, 6 Alcohol Use Disorder Identification Test - Consumption; alcohol use in past month
Change in general health Month 0, 6 1 item on self-reported health ranging between poor (0) and excellent (4)
Change in physical activity Month 0, 1, 3, 6 European Health Interview Survey-Physical Activity Questionnaire, three additional items
Change in decisional balance Month 0, 1, 3, 6 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
Change in diet Month 0, 1, 3, 6 Self-reported number of servings of vegetable and fruit per day; Self-reported intake of fat (gram, kilojoule, kilocalories), fiber (gram), salt (gram) and sugar (gram) 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
Change in body-mass-index Month 0, 6 Obtained from self-reported body weight and height
Change in stage of change Month 0, 1, 3, 6 Behavior-specific staging algorithms based on the transtheoretical model of intentional behavior change (TTM)
Change in sum of behavioral health risk factors Month 0, 1, 3, 6 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)
Change in sick days Month 0, 6 Number of self-reported sick days past 6 months
Change in self-efficacy Month 0, 1, 3, 6 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
Change in processes of change Month 0, 1, 3, 6 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
Trial Locations
- Locations (1)
University Medicine Greifswald
🇩🇪Greifswald, Mecklenburg-Vorpommern, Germany