G35
Conditions
Interventions
Group 1: Intervention group 1: Access to NutriMS-Plus
Group 2: Intervention group 2: Access to NutriMS-Plus with additional personal counselling
Group 3: Wait list control group: Access to NutriMS-Plu
Sponsors
Universitätsklinikum Hamburg-Eppendorf, Institut für Neuroimmunologie und Multiple Sklerose
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Internet access, ability to read German, confirmed MS-diagnosis based on a physician's letter, signed informed consent
Exclusion criteria
Exclusion criteria: No internet access, no ability to read German, no ability to provide a physician’s letter or informed consent, high diet quality expressed as an short Diet Quality Screener (sDQS) score above 41, usage of NutriMS and/or participation in dietary counselling in the MS outpatient clinic of the UKE and/or participation in the validation study of a nutrition knowledge and food literacy questionnaire in the past, self-report of a current or past eating disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following feasibility categories will be assessed as key outcomes of the study: Demand - measured as recruitment duration and success as well as number of participants consented, randomized, withdrawn, lost to follow-up and retained Practicality - measured as number of participants who processed at least eight NutriMS-Plus modules after 12 weeks, number of participants who processed all NutriMS-Plus modules after 12 weeks and number of participants who completed all outcome inventories after 12 weeks Acceptability - measured with the 10-item System Usability Scale (SUS), five items of the Theoretical Framework of Acceptability (TFA) Questionnaire adapted to the intervention and a self-developed Acceptability Questionnaire (sAQ) assessing overall satisfaction as well as the perception of specific features of the intervention by study participants | — |
Secondary
| Measure | Time frame |
|---|---|
| Further outcomes (limited efficacy testing) assessed 12 weeks after randomization include: Diet quality measured using the short Diet Quality Screener (sDQS) MS-specific food literacy measures using the Multiple Sclerosis Food Literacy Questionnaire (MSFLQ) MS-specific nutrition knowledge measured using the Multiple Sclerosis Nutrition Knowledge Questionnaire (MSNKQ) Diet-related health-care behavior measured using the Treatment Self-Regulation Questionnaire subscale for dietary behavior (TRSQ-Diet), the Perceived Competence Scale (PCS) and the Health Care Climate Questionnaire (HCCQ) of the Health-Care Self-Determination Theory Questionnaire Packet | — |
Countries
Germany
Contacts
Public ContactNicole Krause
Universitätsklinikum Hamburg-Eppendorf, Institut für Neuroimmunologie und Multiple Sklerose
Outcome results
None listed