Proactive Automatized Lifestyle Intervention

NCT05365269 | Completed

• 1 other identifier: D8 5000 0001
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Risk Behaviors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (14)

• Satisfaction with intervention

  Month 6

• Change in physical activity

  Month 0, 1, 3, 6

• Change in diet

  Month 0, 1, 3, 6

• Change in alcohol use

  Month 0, 1, 3, 6

• Change in tobacco smoking

  Month 0, 1, 3, 6

Other Outcomes (7)

• Change in non-communicable diseases

  Month 0, 6

• Change in utilization of health care - general practitioner

  Month 0, 6

• Change in utilization of health care - medical specialist

  Month 0, 6

Study Arms (1)

Computer-generated feedback on health risk behaviors

EXPERIMENTAL

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

Interventions

Proactive Automatized Lifestyle intervention BEHAVIORAL

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

Computer-generated feedback on health risk behaviors

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medicine Greifswald: lead
• Deutsche Krebshilfe e.V., Bonn (Germany): collaborator
• Robert Koch Institut: collaborator
• University Hospital Schleswig-Holstein: collaborator

Study Sites (1)

University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Related Publications (3)

• Spielmann M, Krolo-Wicovsky F, Tiede A, John U, Freyer-Adam J. Proactive automatized multiple health risk behavior change intervention: reach and retention among general hospital patients. Eur J Public Health. 2025 Aug 1;35(4):635-641. doi: 10.1093/eurpub/ckaf035.

  PMID: 40101761 DERIVED

• Timm C, Krolo-Wicovsky F, Tiede A, Spielmann M, Gaertner B, John U, Freyer-Adam J. General hospital patients' attitude towards systematic health risk behavior screening and intervention. BMC Public Health. 2024 Oct 18;24(1):2877. doi: 10.1186/s12889-024-20410-2.

  PMID: 39425090 DERIVED

• 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.

  PMID: 36123081 DERIVED

MeSH Terms

Conditions

Health Risk Behaviors

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: By nature, the participants, investigators and outcomes assessors of the single arm study are informed that an intervention is being (or has been) delivered.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 9, 2022
• Study Start: May 31, 2022
• Primary Completion: March 31, 2023
• Study Completion: April 24, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data won't be publicly available due to the German data protection law.
• 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.

Locations

DE (1)