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Completed

NCT Number: NCT05365269

Proactive Automatized Lifestyle Intervention

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.

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Key information

Conditions

Health Risk Behaviors Behavior Health Behavior

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proactive Automatized Lifestyle intervention

Behavioral

Multi-behavioral; including individually-tailored, theory-based, repetitive, ipsative and normative feedback.

Primary outcomes

  1. Intervention reach

    Time frame: Month 0

    Proportion of participants among all eligible patients

  2. Intervention retention

    Time frame: Month 1

    Proportion of participants who continue participation 1 month after hospitalization

  3. Intervention retention

    Time frame: Month 3

    Proportion of participants who continue participation 3 months after hospitalization

Secondary outcomes

  1. Satisfaction with intervention

    Time frame: 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)

  2. Change in physical activity

    Time frame: Month 0, 1, 3, 6

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

  3. Change in diet

    Time frame: 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

  4. Change in alcohol use

    Time frame: Month 0, 1, 3, 6

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

  5. Change in tobacco smoking

    Time frame: Month 0, 1, 3, 6

    Self-reported number of cigarettes per day; smoking status

  6. Change in sum of behavioral health risk factors

    Time frame: 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)

  7. Change in body-mass-index

    Time frame: Month 0, 6

    Obtained from self-reported body weight and height

  8. Change in general health

    Time frame: Month 0, 6

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

  9. Change in mental health

    Time frame: Month 0, 6

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

  10. Change in sick days

    Time frame: Month 0, 6

    Number of self-reported sick days past 6 months

  11. Change in stage of change

    Time frame: Month 0, 1, 3, 6

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

  12. Change in decisional balance

    Time frame: 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

  13. Change in self-efficacy

    Time frame: 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

  14. Change in processes of change

    Time frame: 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

Other outcomes

  1. Change in non-communicable diseases

    Time frame: Month 0, 6

    Self-reported cardio-vascular disease, chronic respiratory disease, cancer disease, diabetes

  2. Change in utilization of health care - general practitioner

    Time frame: Month 0, 6

    Self-reported consultation of general practitioners past 6 months (number)

  3. Change in utilization of health care - medical specialist

    Time frame: Month 0, 6

    Self-reported consultation of medical specialists past 6 months (number)

  4. Change in utilization of health care - physiotherapist

    Time frame: Month 0, 6

    Self-reported consultation of physiotherapists past 6 months (yes/no)

  5. Change in utilization of health care - psychologist/ psychotherapist/ psychiatrist

    Time frame: Month 0, 6

    Self-reported consultation of psychologist/ psychotherapist/ psychiatrist past 6 months (yes/no)

  6. Change in utilization of health care - inpatient

    Time frame: Month 0, 6

    Self-reported inpatient hospital care past 6 months (number of nights)

  7. Change in utilization of health care - outpatient

    Time frame: Month 0, 6

    Self-reported outpatient hospital care past 6 months (number of admissions)

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)
  • Robert Koch Institut
  • University Hospital Schleswig-Holstein

Registry information

Official study title

Proactive Automatized Lifestyle Intervention for Cancer Prevention

Acronym: PAL

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 9, 2022
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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