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NCT05365269 | Completed | Health Risk Behaviors


Proactive Automatized Lifestyle Intervention
Sponsor:

University Medicine Greifswald

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.

Condition or disease

Health Risk Behaviors

Intervention/treatment

Proactive Automatized Lifestyle intervention

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 175 participants
Masking: None (Open Label)
Masking Description: By nature, the participants, investigators and outcomes assessors of the single arm study are informed that an intervention is being (or has been) delivered.
Primary Purpose: Prevention
Official Title: Proactive Automatized Lifestyle Intervention for Cancer Prevention
Actual Study Start Date : May 31, 2022
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : April 24, 2023
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

Ages Eligible for Study: 18 Years to 64 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

Proactive Automatized Lifestyle Intervention

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Proactive Automatized Lifestyle Intervention

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Locations


Not yet recruiting

Germany, Mecklenburg-Vorpommern

University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany, 17475

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