To determine the effect size of the difference in nutritional intake (carbohydrates, calories, fiber) of MASLD patients before and after playing the serious game. In addition, information provision, information needs, physical activity, response…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is the effect size of the difference in calorie,
carbohydrate and fiber intake before and after using the serious game.
Secondary outcome
Secondary outcome measures include information provision, information needs,
response efficacy, self-efficacy, motivation to change lifestyle, exercise
according to exercise norm, clinical outcomes (such as BMI and liver enzymes)
and fatigue. Users' experiences with the game, actual game use and study
procedures will also be evaluated during the study.
Background summary
Although lifestyle modification is currently the only remedy for improving
metabolic dysfunction-associated steatotic liver disease (MASLD), in practice
patients find it difficult to change lifestyle and maintain the new behaviors.
A lack of knowledge about MASLD among patients plays an important role in this.
As does the lack of time among healthcare providers to invest sufficient time
in knowledge transfer and patient empowerment. eHealth offers the opportunity
to share reliable information with a large group of patients in the patient's
own time and in their own home environment. A serious game is an example of
this. Serious games have shown to be effective in supporting behavior change
and factors related to it, such as increasing awareness, knowledge and
motivation. Therefore, a serious game has been developed for MASLD patients.
The preparations for developing the serious game consisted of a nationwide
survey of 450 MASLD patients. This revealed, among other things, that patients
would like to receive broad information about MASLD. Regarding eHealth,
patients again indicated a need for information on MASLD, practical examples
and referral to relevant websites/apps. The input from this survey was included
in the development of the serious game.
Study objective
To determine the effect size of the difference in nutritional intake
(carbohydrates, calories, fiber) of MASLD patients before and after playing the
serious game. In addition, information provision, information needs, physical
activity, response efficacy, self-efficacy, motivation, clinical outcomes (such
as BMI and liver values) and fatigue before and after using the serious game
will be examined. Users' experiences with the game, actual game use and study
procedures will also be evaluated during the study.
Study design
Pilot study consisting of three aspects: 1) pre-post test, 2) in-depth
interviews and 3) analysis of log data.
Intervention
Each participant uses the serious game for 6 weeks in addition to usual care.
The serious game consists of 5 levels with quiz questions and a nutrition game.
Study burden and risks
The study requires some effort from the participant in the form of using the
app (i.e. playing the quizzes), three 24h recalls and completing three
questionnaires and possibly an interview. No physical exercise is required and
the questionnaires do not contain burdensome questions. Also, the participant
does not need to visit the hospital more often and no additional blood tests
are performed. Participation in the study can be beneficial as the serious game
can give the participant insight into his/her condition and also explain what
possibilities there are to improve the condition by adapting to a healthy
lifestyle. There are no risks associated with the use of the serious game
itself.
Koningstraat 1
Enschede 7512 KZ
AF
Koningstraat 1
Enschede 7512 KZ
AF
Listed location countries
Age
Inclusion criteria
- Dutch adults diagnosed with MASLD in accordance with the current guideline
(FMS, 2024).
- Age 18-70 years
- Referred to the MDL outpatient clinic of MST Enschede due to MASLD.
- Patients with and without MASLD-related liver cirrhosis.
- Proficiency in Dutch
Exclusion criteria
- Compensated liver cirrhosis
- Expected survival < 6 months
- Diabetes mellitus type I or II and medication use (except monotherapy with
metformin).
- Cognitive impairment
- Severe visual impairment that makes reading text on a smartphone difficult.
- Not having access to a recently updated Android (version 13) or Apple
(version 16) smartphone and mobile internet
- Having no or insufficient experience in using a smartphone.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87269.100.24 |