Proactive Automatized Lifestyle Intervention (PAL)

Proactive Automatized Lifestyle Intervention for Cancer Prevention

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.

Study Overview

• Status: Completed
• Conditions: Health Risk Behaviors
• Intervention / Treatment: Behavioral: Proactive Automatized Lifestyle intervention

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Mecklenburg-Vorpommern
    • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
      • University Medicine Greifswald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computer-generated feedback on health risk behaviors; Proactive Automatized Lifestyle intervention Frequency: 3 times (month 0, 1, 3) Dosage: Individually tailored feedback corresponding to about 1-6 pages Duration: 3 months	Behavioral: Proactive Automatized Lifestyle intervention; Multi-behavioral; including individually-tailored, theory-based, repetitive, ipsative and normative feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention reach	Proportion of participants among all eligible patients	Month 0
Intervention retention	Proportion of participants who continue participation 1 month after hospitalization	Month 1
Intervention retention	Proportion of participants who continue participation 3 months after hospitalization	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in physical activity	European Health Interview Survey-Physical Activity Questionnaire, three additional items	Month 0, 1, 3, 6
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
Change in alcohol use	Alcohol Use Disorder Identification Test - Consumption; alcohol use in past month	Month 0, 1, 3, 6
Change in tobacco smoking	Self-reported number of cigarettes per day; smoking status	Month 0, 1, 3, 6
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
Change in body-mass-index	Obtained from self-reported body weight and height	Month 0, 6
Change in general health	1 item on self-reported health ranging between poor (0) and excellent (4)	Month 0, 6
Change in mental health	5-item Mental Health Inventory; Higher scores indicate better mental health	Month 0, 6
Change in sick days	Number of self-reported sick days past 6 months	Month 0, 6
Change in stage of change	Behavior-specific staging algorithms based on the transtheoretical model of intentional behavior change (TTM)	Month 0, 1, 3, 6
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in non-communicable diseases	Self-reported cardio-vascular disease, chronic respiratory disease, cancer disease, diabetes	Month 0, 6
Change in utilization of health care - general practitioner	Self-reported consultation of general practitioners past 6 months (number)	Month 0, 6
Change in utilization of health care - medical specialist	Self-reported consultation of medical specialists past 6 months (number)	Month 0, 6
Change in utilization of health care - physiotherapist	Self-reported consultation of physiotherapists past 6 months (yes/no)	Month 0, 6
Change in utilization of health care - psychologist/ psychotherapist/ psychiatrist	Self-reported consultation of psychologist/ psychotherapist/ psychiatrist past 6 months (yes/no)	Month 0, 6
Change in utilization of health care - inpatient	Self-reported inpatient hospital care past 6 months (number of nights)	Month 0, 6
Change in utilization of health care - outpatient	Self-reported outpatient hospital care past 6 months (number of admissions)	Month 0, 6

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Collaborators: University Hospital Schleswig-Holstein; Deutsche Krebshilfe e.V., Bonn (Germany); Robert Koch Institut
• Investigators: Principal Investigator: Jennis Freyer-Adam, Prof. Dr., University Medicine Greifswald, Institute of Medical Psychology; Principal Investigator: Ulrich John, Prof. Dr., University Medicine Greifswald, Institute CM, Department of Prevention Research and Social Medicine

Publications and helpful links

General Publications

• Freyer-Adam J, Krolo F, Tiede A, Goeze C, Sadewasser K, Spielmann M, Krause K, John U. Proactive automatised lifestyle intervention (PAL) in general hospital patients: study protocol of a single-group trial. BMJ Open. 2022 Sep 19;12(9):e065136. doi: 10.1136/bmjopen-2022-065136.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): April 24, 2023

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: D8 5000 0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that underlie results in a publication may be shared
• IPD Sharing Time Frame: The data won't be publicly available due to the German data protection law.
• IPD Sharing Access Criteria: The data may be made available on reasonable request that complies with the study purpose, the participants' informed consent and the German data protection law. The request will be reviewed by the principle investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No