A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis (MS)
18 de maio de 2018 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Real)
54
Estágio
- Não aplicável
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Comparador de 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.
|
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.
|
|
Sem intervenção: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adherence
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Body Mass Index (BMI)
Prazo: Baseline and 6 months
|
Change in body mass index from baseline to 6 months.
|
Baseline and 6 months
|
|
Weight Change
Prazo: Baseline and 6 months
|
Change in participant weight over the 6-month study period
|
Baseline and 6 months
|
|
Weight Change Among Adherent Participants
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Ellen Mowry, MD, Johns Hopkins University
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de agosto de 2016
Conclusão Primária (Real)
1 de junho de 2017
Conclusão do estudo (Real)
1 de julho de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
20 de julho de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de julho de 2016
Primeira postagem (Estimativa)
27 de julho de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
15 de junho de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de maio de 2018
Última verificação
1 de maio de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB00105123
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant's data will not be shared
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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