Proactive Automatized Lifestyle Intervention

NCT ID: NCT05365269

Last Updated: 2023-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2023-04-24

Brief Summary

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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

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Conditions

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Health Risk Behaviors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

By nature, the participants, investigators and outcomes assessors of the single arm study are informed that an intervention is being (or has been) delivered.

Study Groups

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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

Group Type EXPERIMENTAL

Proactive Automatized Lifestyle intervention

Intervention Type BEHAVIORAL

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

Interventions

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Proactive Automatized Lifestyle intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsche Krebshilfe e.V., Bonn (Germany)

OTHER

Sponsor Role collaborator

Robert Koch Institut

OTHER_GOV

Sponsor Role collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role collaborator

University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennis Freyer-Adam, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald, Institute of Medical Psychology

Ulrich John, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald, Institute CM, Department of Prevention Research and Social Medicine

Locations

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University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 40101761 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39425090 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36123081 (View on PubMed)

Other Identifiers

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D8 5000 0001

Identifier Type: -

Identifier Source: org_study_id

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