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A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis (MS)

18 maggio 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

54

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: Frequent Patient Interaction
Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
Dispositivo: LoseIt! Smartphone Application
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.
Sperimentale: 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.
Comportamentale: Timing Restriction
Patients continue to follow their normal diet, but limit food intake to an 8-hour period during the day.
Comparatore placebo: 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.
Dispositivo: LoseIt! Smartphone Application
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.
Nessun intervento: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adherence
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Body Mass Index (BMI)
Lasso di tempo: Baseline and 6 months
Change in body mass index from baseline to 6 months.
Baseline and 6 months
Weight Change
Lasso di tempo: Baseline and 6 months
Change in participant weight over the 6-month study period
Baseline and 6 months
Weight Change Among Adherent Participants
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Johns Hopkins University

Investigatori

  • Investigatore principale: Ellen Mowry, MD, Johns Hopkins University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2016

Completamento primario (Effettivo)

1 giugno 2017

Completamento dello studio (Effettivo)

1 luglio 2017

Date di iscrizione allo studio

Primo inviato

20 luglio 2016

Primo inviato che soddisfa i criteri di controllo qualità

22 luglio 2016

Primo Inserito (Stima)

27 luglio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 giugno 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 maggio 2018

Ultimo verificato

1 maggio 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB00105123

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant's data will not be shared

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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