protocolSection identificationModule nctId: NCT06277232, orgStudyIdInfo id: HMV-2023-00504, secondaryIdInfos id: 2022-05364-02, type: OTHER, domain: The Swedish Ethical Review Authority, briefTitle: Nutrition Care in Patients Living With Chronic Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Linkoeping University, class: OTHER_GOV, collaborators name: Ostergotland County Council, Sweden, collaborators name: Fibromyalgia foundation, descriptionModule briefSummary: The investigators' purpose is to develop and test the feasibility, usability, and satisfaction of the Diet4painrelief app as a platform for implementing nutrition care in a specialist pain rehabilitation clinic. The Diet4painrelief will consist of two components: a) a screening tool for nutrition status b) an individually tailored behavior change program aiming to improve the dietary habits and behaviors of patients living with chronic pain.The study is planned to include 20 patients with complex chronic pain and non-optimal BMI (underweight or overweight/obesity) to examine the feasibility and outcomes of evidence-based Interdisciplinary Pain Rehabilitation Program (IPRP) integrated with nutrition care. The Diet4painrelief includes a screening tool to assess basic nutritional status as well as their intake of key unhealthy and healthy foods and drinks (through three 24hour-dietary recordings or food diary). Thereafter, the patients receive a personalized behavior change program for dietary optimization. The investigators will design and adapt 6 modules in the digital platform (Diet4painrelief app) based on the International Association for the Study of Pain (IASP) recommendations (6 aspects about 'nutrition and pain') and Sweden's food culture. Clinical outcomes using patient-reported data on socio-demographics, pain aspects, psychometric data, physical disability, and quality of life will be measured at three occasions: first appointment (Pre-IPRP), immediately after completing the rehabilitation program (Post-IPRP), and at a 12-month follow-up (FU-IPRP). Blood samples will be taken to identify biomarkers at the same occasions that provide objective information on metabolic and nutritional abnormalities and further to evaluate the effect of the dietary intervention on changing of pain rehabilitation outcomes., conditionsModule conditions: Nutrition Poor, conditions: Overweight and Obesity, conditions: Mobile Phone Use, conditions: Pain, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Repeated measures, single-subject withdrawal design. All subjects who enroll in the study will receive the intervention and there is no randomization., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Nutrition care, interventions name: Dialogue and education (part of Interdisciplinary Pain Rehabilitation Program), interventions name: activity training (part of Interdisciplinary Pain Rehabilitation Program), interventions name: meetings (part of Interdisciplinary Pain Rehabilitation Program), interventions name: Cognitive behavioral therapy (part of Interdisciplinary Pain Rehabilitation Program), interventions name: Relaxation techniques (part of Interdisciplinary Pain Rehabilitation Program), interventions name: Physical exercise (part of Interdisciplinary Pain Rehabilitation Program), outcomesModule primaryOutcomes measure: Pain intensity (numeric rating scale), primaryOutcomes measure: Pain interference (one aspect in Multidimensional Pain inventory), primaryOutcomes measure: Dietary habits (a lifestyle questionnaire), primaryOutcomes measure: Perceived Usability (System Usability Scale), primaryOutcomes measure: Perceived benefit (numeric rating scale), primaryOutcomes measure: Adherences/ compliances of nutritional care (numeric rating scale), secondaryOutcomes measure: Difficulty sleeping (Insomnia Severity Index), secondaryOutcomes measure: Emotional distress (The Hospital Anxiety and Depression Scale, HAD), secondaryOutcomes measure: Impact of chronic pain (Multidimensional Pain inventory), secondaryOutcomes measure: Health- related quality of life 1 (EQ-5D), secondaryOutcomes measure: Health- related quality of life 2 (RAND-36), secondaryOutcomes measure: Pain coping (Chronic Pain Acceptance Questionnaire, CPAQ), secondaryOutcomes measure: Fear of movement (Tampa scale for Kinesiophobia), secondaryOutcomes measure: Physical activity and sedentary behavior (self-estimated time, questionnaire), secondaryOutcomes measure: Body fatness (physiological parameter), secondaryOutcomes measure: Body weight (physiological parameter), secondaryOutcomes measure: Biomarkers explored from blood samples (physiological parameters such as proteins, lipids, metabolites and micro-RNA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False