Lifestyle interventions for patients with non-alcoholic steato-hepatitis-Design, rationale and protocol of the study "target group-specific optimisation of lifestyle interventions for behavior change in non-alcoholic steato-hepatitis (OPTI-NASH)"

PLoS One. 2023 Jul 27;18(7):e0288905. doi: 10.1371/journal.pone.0288905. eCollection 2023.

Abstract

Background: Non-alcoholic steato-hepatitis (NASH) is the inflammatory, progressive form of non-alcoholic fatty liver disease (NAFLD). A delayed diagnose interval is typical for the majority of the patients because of the asymptomatic natural course. However, serious sequelae may develop such as cirrhosis or hepatocellular carcinoma. NASH is also associated with an increased risk of metabolic diseases. Obesity developed due to a lack of exercise or a disadvantageous diet often leads to NAFLD or NASH, thereby interventions including enhanced physical activity and calorie reduction form the actual gold standard of treatment. To date, patients rarely use these. The project aims to model lifestyle interventions based on the preferences of the NASH patients.

Methods: Based on a systematic review and focus group discussions, two discrete choice experiments (DCE) will be designed, one on aspects influencing successful uptake of lifestyle interventions and one to analyses parameters contributing to long-term participation. An online survey will be used to elicit patient's preferences on program design and on motivational aspects in a cross-sectional design. The recruitment will take place in nine certified specialist practices and hospital outpatient clinics aiming to reach a sample size of n = 500 which is also required for the DCE design.

Discussion: The results will provide an overview of the NASH patient's preferences regarding the successful uptake and long-term implementation of lifestyle interventions. Recommendations for optimized lifestyle change programs will be derived and an intervention manual will be developed to facilitate target group-specific inclusion in programs in practice.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cross-Sectional Studies
  • Hepatitis, Alcoholic*
  • Humans
  • Life Style
  • Non-alcoholic Fatty Liver Disease* / diagnosis
  • Non-alcoholic Fatty Liver Disease* / therapy
  • Obesity
  • Systematic Reviews as Topic

Grants and funding

This study is funded (on the basis of a peer review) by the German Federal Joint Committee’s Innovation Fund (grant number 01VSF22032) from 1 January 2023 to 31 December 2025 (URL to sponsors’ website: https://innovationsfonds.g-ba.de/). The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.