Feasibility of a Diet Intervention for Juvenile Arthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorThe Hospital for Sick Children
About this trial
Families of children with arthritis are highly interested in the benefits of diet to improve their child's disease and future health outcomes. Previous research shows that the germs - bacteria and other organisms - that live in the intestines (gut microbiome) are important to how well immune systems work, and that what people eat changes their gut microbiome. The investigators want to study whether a certain diet - based on the principles of the Mediterranean Diet - will improve arthritis for children and whether it was changes in the microbiome that led to improvement.
Fifty-four participants in this study will change their diet for an 8-week period, and will have the option of remaining on the diet for an additional 4 weeks. At three time points during the study (beginning, 8 weeks, and 12 weeks), participants will provide stool and blood samples, will complete questionnaires about diet and other aspects of lifestyle and health, and will complete a disease assessment by a clinician. From collecting all these samples and information, the investigators will be able to determine if the diet was successful in improving disease activity in children with arthritis and if the gut microbiome was changed as well.
This study will help the investigators figure out if a larger, and more definitive, study like this is possible to do in children with arthritis and will help the investigators design a bigger multinational study to confirm how diet affects disease outcomes and the microbiome in children with arthritis. If successful, this research will provide scientific knowledge to help families make their way through this difficult to- navigate topic.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 8-18 years
Diagnosis of JIA (excluding systemic JIA, enthesitis-related arthritis, and rheumatoid factor (RF) positive polyarthritis) as per International League of Associations for Rheumatology (ILAR) criteria. (For this feasibility study, there will be no requirement for any particular level of disease activity.)
Subjects on stable treatment - i.e., any medical treatment with disease-modifying antirheumatic drugs (DMARDs) and/or systemic or intraarticular corticosteroids, has been unchanged for 8 weeks, and is unlikely to change for 12 weeks as judged by the treating physician.
Willingness to provide stool samples.
Disqualifiers
Documented specific food allergies, celiac disease.
Co-morbidities that might impact the tolerability of the study diet, e.g., type I diabetes, peptic ulcer disease, etc.
Trial design
Design model
Single group
Treatments tested in this trial
Diet intervention
Other interventionA diet based on the principles of the Mediterranean Diet (MedDiet): consists of an abundance of plant foods - unrefined cereals, fruit, vegetables, and extra-virgin olive oil - a moderate consumption of poultry, dairy products, eggs, and low consumption of sweets and red meats. All subjects will be instructed to follow the MedDiet for 8 weeks by the study team. Families will be given the option to continue for 12 weeks if they wish to do so.
Treatment groups
54 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
(Feasibility 1) Participant accrual rate:
The proportion of all subjects who are approached that enroll and the accrual frequency at each site.
Time frame
8-12 weeks2
(Feasibility 2) The proportion of subjects who complete all the various measurement steps
Including return of the fecal samples, gender identification, completion rate of the food diary, etc. The proportion of subjects who continue in the 12-week extension will be recorded.
Time frame
8-12 weeks3
(Feasibility 3) Nutrient intake
Measured by the participants completing an ecologic momentary assessment (EMA) food diary and the corresponding Prospective Urban Rural Epidemiology (PURE) scores. The PURE score is calculated based on what the subjects entered in their EMA food diary. The score is from 0-6, with a higher score representing a healthier diet.
Time frame
8-12 weeks4
(Feasibility 4) Adherence to the MedDiet
Measured by Mediterranean Diet Quality Index in children and adolescents (KIDMED) a questionnaire that measures adherence to the MedDiet scores. The index ranges from 0-12. The values are classified into three levels: \> 8 is optimal MedDiet, 4-7 means improvement needed to adjust intake to MedDiet patterns, and ≤ 3 is low diet quality.
Time frame
8-12 weeksSecondary outcomes
1
(Confounder 1) Sleep quality
Measured by FitBit accelerometry
Time frame
8-12 weeks2
(Confounder 2) Patient-reported Sleep Quality
Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbances questionnaire. The total score ranges from 0-40 with a higher score representing a poor sleep quality.
Time frame
8-12 weeks3
(Confounder 3) Physical activity
Measured by the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GODIN) exercise questionnaire. A total score of 24 or more is active, 14 - 23 is moderately active, and less than 14 units is sedentary.
Time frame
8-12 weeks4
(Confounder 4) Sex
Results will be stratified by sex at birth.
Time frame
8-12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Hospital for Sick Children
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov