Proactive Automatized Lifestyle Intervention

Health Risk Behaviors Clinical Trial

— PAL  

Official title:

Proactive Automatized Lifestyle Intervention for Cancer Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05365269
• Other study ID #: D8 5000 0001
• Status: Completed
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: April 24, 2023

Study information

• Verified date: June 2023
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: April 24, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Health Risk Behaviors

Intervention

Behavioral:
• Proactive Automatized Lifestyle intervention
Multi-behavioral; including individually-tailored, theory-based, repetitive, ipsative and normative feedback.

Locations

Country	Name	City	State
Germany	University Medicine Greifswald	Greifswald	Mecklenburg-Vorpommern

Sponsors (4)

Lead Sponsor	Collaborator
University Medicine Greifswald	Deutsche Krebshilfe e.V., Bonn (Germany), Robert Koch Institut, University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in non-communicable diseases	Self-reported cardio-vascular disease, chronic respiratory disease, cancer disease, diabetes	Month 0, 6
Other	Change in utilization of health care - general practitioner	Self-reported consultation of general practitioners past 6 months (number)	Month 0, 6
Other	Change in utilization of health care - medical specialist	Self-reported consultation of medical specialists past 6 months (number)	Month 0, 6
Other	Change in utilization of health care - physiotherapist	Self-reported consultation of physiotherapists past 6 months (yes/no)	Month 0, 6
Other	Change in utilization of health care - psychologist/ psychotherapist/ psychiatrist	Self-reported consultation of psychologist/ psychotherapist/ psychiatrist past 6 months (yes/no)	Month 0, 6
Other	Change in utilization of health care - inpatient	Self-reported inpatient hospital care past 6 months (number of nights)	Month 0, 6
Other	Change in utilization of health care - outpatient	Self-reported outpatient hospital care past 6 months (number of admissions)	Month 0, 6
Primary	Intervention reach	Proportion of participants among all eligible patients	Month 0
Primary	Intervention retention	Proportion of participants who continue participation 1 month after hospitalization	Month 1
Primary	Intervention retention	Proportion of participants who continue participation 3 months after hospitalization	Month 3
Secondary	Satisfaction with intervention	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)	Month 6
Secondary	Change in physical activity	European Health Interview Survey-Physical Activity Questionnaire, three additional items	Month 0, 1, 3, 6
Secondary	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) 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	Month 0, 1, 3, 6
Secondary	Change in alcohol use	Alcohol Use Disorder Identification Test - Consumption; alcohol use in past month	Month 0, 1, 3, 6
Secondary	Change in tobacco smoking	Self-reported number of cigarettes per day; smoking status	Month 0, 1, 3, 6
Secondary	Change in sum of behavioral health risk factors	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)	Month 0, 1, 3, 6
Secondary	Change in body-mass-index	Obtained from self-reported body weight and height	Month 0, 6
Secondary	Change in general health	1 item on self-reported health ranging between poor (0) and excellent (4)	Month 0, 6
Secondary	Change in mental health	5-item Mental Health Inventory; Higher scores indicate better mental health	Month 0, 6
Secondary	Change in sick days	Number of self-reported sick days past 6 months	Month 0, 6
Secondary	Change in stage of change	Behavior-specific staging algorithms based on the transtheoretical model of intentional behavior change (TTM)	Month 0, 1, 3, 6
Secondary	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	Month 0, 1, 3, 6
Secondary	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	Month 0, 1, 3, 6
Secondary	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	Month 0, 1, 3, 6