A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis (MS)
18 maj 2018 uppdaterad av: Johns Hopkins University
A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis
This is a pragmatic, single-blinded randomized trial of improving adherence to dietary interventions in patients with MS who are receiving monthly natalizumab infusions.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
MS affects at least 400,000 people in the US alone, and its incidence has increased in the past 50 years, likely due to changing environmental risk factors. Recent research suggests that diet may be a critical factor in the development of MS. The "Western diet", high in sugar, fat, and salt, may influence MS risk and progression by directly affecting the immune system, altering gut bacteria, and changing metabolism.
Studying patients with MS who are overweight and obese may be relevant as obesity can cause chronic low-grade inflammation, potentially worsening MS symptoms. Diet modification represents an interesting potential therapy for MS, particularly calorie restriction and fasting, which have been associated with reduced markers of inflammation. In addition to these direct effects, weight optimization may lead to improvements in MS-related symptoms, like fatigue, and overall quality of life.
This is a single-blinded randomized trial of adherence to a dietary intervention in patients with MS who are receiving monthly natalizumab infusions. The study will evaluate how use of technology may help patients with MS adhere to a calorie restricted diet. It will also evaluate the effect of weight loss on fatigue and quality of life in patients with MS. A second part of the study will evaluate if shortening the period during the day in which people consume their typical food amounts leads to improvements in patient-reported outcomes.
Studietyp
Interventionell
Inskrivning (Faktisk)
54
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Body Mass Index (BMI) ≥ 25 kg/m^2 for calorie restriction study
- BMI < 25 kg/m^2, or ≥ 25 kg/m^2 if participant was unwilling to enroll in calorie restriction study
- Smartphone with the ability to download and use the LoseIt! application (calorie restriction only)
- Smartphone with the ability to take and store photos (calorie timing only)
Exclusion Criteria:
- History of diabetes requiring medication
- Currently pregnant or breastfeeding
- History of an eating disorder
- Currently taking warfarin
- History of major surgery within past 3 months
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Calorie Restriction - Frequent Patient Communication
MS patients receiving monthly natalizumab infusions will use the LoseIt!
smartphone application to log daily food consumption.
Data from the app will be collected at follow-up visits.
Patients will receive initial training in using the app, and then receive weekly supportive messages encouraging them to adhere to the calorie restriction diet between 3- and 6-month followup visits.
Results will be compared primarily to those collected from the Standard of Care arm.
|
Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
Patients will be trained by study staff to download the LoseIt!
application, and use it to log all food intake throughout the study duration.
Data collected from the application will be the primary measure of adherence to dietary changes.
|
|
Experimentell: Timing Restriction
MS patients receiving monthly natalizumab infusions who are ineligible for the calorie restriction portion of the study (the Frequent Patient Activation and Standard of Care arms) will be offered the option to enroll in the second part of the study, assessing differences in outcomes between daily 16-hour fasting periods and no dietary changes.
Patients in the second part of the study randomized to this arm will consume their normal daily food intake, but restrict eating to an 8-hour period during the day.
Results will be compared to patients who do not make any changes to their diet, the No Change arm.
|
Patients continue to follow their normal diet, but limit food intake to an 8-hour period during the day.
|
|
Placebo-jämförare: Calorie Restriction - Communication Standard of Care
MS patients receiving monthly natalizumab infusions will use the LoseIt!
smartphone application to log daily food consumption.
Data from the app will be collected at follow-up visits.
Besides initial training with the application and 3- and 6-month follow up exams, participants will not receive additional support or interaction from the study team.Results will be compared with those collected from the Frequent Patient Interaction arm.
|
Patients will be trained by study staff to download the LoseIt!
application, and use it to log all food intake throughout the study duration.
Data collected from the application will be the primary measure of adherence to dietary changes.
|
|
Inget ingripande: No Diet Change
MS patients receiving natalizumab infusions who were ineligible for the calorie restriction portion of the study (e.g.
body mass index < 25 kg/m^2) or did not wish to participate in calorie restriction, may elect to be part of the second portion of the study.
If so, they may be randomized to this arm, in which no changes are made to amount or timing of daily food intake.
Results will be compared with the experimental Timing arm
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Adherence
Tidsram: Baseline and 6 months
|
Number of participants adhering to the prescribed dietary intervention at the end of the 6-month study period.
|
Baseline and 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Body Mass Index (BMI)
Tidsram: Baseline and 6 months
|
Change in body mass index from baseline to 6 months.
|
Baseline and 6 months
|
|
Weight Change
Tidsram: Baseline and 6 months
|
Change in participant weight over the 6-month study period
|
Baseline and 6 months
|
|
Weight Change Among Adherent Participants
Tidsram: Baseline and 6 months
|
The change in weight over 6 months among participants were remained adherence to the calorie restriction diet versus those who admitted to non-compliance by the end of the study period.
|
Baseline and 6 months
|
|
Functional Assessment in MS Score
Tidsram: Baseline and 6 months
|
The Functional Assessment in Multiple Sclerosis (FAMS) is an instrument that measures quality of life among people with MS.
The instrument contains 44 questions scored on a 5-point Likert scale in 6 areas: mobility, symptoms, emotional wellbeing, general contentment, thanking/fatigue, and family/social wellbeing.
Subscores for each area is calculated as the sum of responses in that section, and the total FAMS score is the sum of all subscores.
Minimum total score is 0 and maximum total score is 176, where a higher score indicates better quality of life.
Increase in the FAMS score over the study period indicates a better outcome, or improved quality of life, among participants.
|
Baseline and 6 months
|
|
Fatigue
Tidsram: Baseline and 6 months
|
The Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue is a question bank of 95 items validated to evaluated fatigue in a variety of chronic conditions.
The PROMIS-FatigueMS is a subset of 8 questions from the question bank, which have been validated to measure fatigue in people with multiple sclerosis.
Individual items are scored on a 5-point Likert scale, and the total score is the sum of individual items, with a minimum score of 8 and maximum score of 40.
Lower scores indicate less fatigue, while higher scores indicate more fatigue.
Reduction in score over 6 months indicates a better outcome, or improved fatigue among participants.
|
Baseline and 6 months
|
|
Sleep Quality
Tidsram: Baseline and 6 months
|
The Pittsburgh Sleep Quality Index (PSQI) is an instrument used to measure the quality and sleeping pattern of adults.
It differentiates "poor" from "good" sleep quality, and the total score is calculated from the sum of seven components, each scored from 0 to 3. The minimum total score is 0 and the maximum total score is 21.
A total score equal to or greater than 5 units indicates "poor" quality sleep, while a score of 0-4 indicates "good" quality sleep; lower scores indicate better sleep quality.
Decrease in PSQI score indicates a better outcome, or improved sleep quality, among study participants.
|
Baseline and 6 months
|
|
Self-esteem
Tidsram: Baseline and 6 months
|
The Rosenberg Self-Esteem Scale (RSES) is a 10-item scale that measures global self-worth using a 4-point Likert scale to ask about negative and positive feelings about the self.
Individual items are summed to calculate the total score.
Minimum score is 0 and maximum score is 30.
Scores between 15 and 25 are considered within the normal range, while scores below 15 indicates poor self-esteem.
An increase in RSES score over 6 months indicates a better outcome, or improved self-esteem, among participants.
|
Baseline and 6 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Ellen Mowry, MD, Johns Hopkins University
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2016
Primärt slutförande (Faktisk)
1 juni 2017
Avslutad studie (Faktisk)
1 juli 2017
Studieregistreringsdatum
Först inskickad
20 juli 2016
Först inskickad som uppfyllde QC-kriterierna
22 juli 2016
Första postat (Uppskatta)
27 juli 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 juni 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 maj 2018
Senast verifierad
1 maj 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00105123
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Individual participant's data will not be shared
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