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Effectiveness of an Eight Week Online Mediterranean Based Diet

6 de maio de 2022 atualizado por: Linda Libertini, The Cleveland Clinic

Effectiveness of an Eight Week Online Mediterranean Based Diet in an Overweight or Obese Outpatient Primary Care Population

This research is examining whether an 8-week online nutritional programming based on a Mediterranean diet can achieve meaningful increase intake of a Mediterranean based diet and improvements in measures of body weight and laboratory measures of oxidative stress, a risk marker for cardiovascular disease. This study will also examine whether weekly short support and communication from a medical assistant (MA) in a primary care setting in addition to the online program will result in better program adherence and have a positive impact on health.

Visão geral do estudo

Status

Retirado

Condições

Intervenção / Tratamento

Descrição detalhada

Eligible participants will be identified by primary care providers or their staff at clinical outpatient site(s). Study is 3-arm randomized control trial where participants will be randomized to 1) Control group (CTL)-will not receive access to online program nor intervention for first 12 weeks; 2) GFFY-1-will receive access to online program without MA intervention 3) GFFY-2-will receive access to online program and MA intervention with weekly phone call. The core of the intervention is an 8-week Mediterranean diet and behavioral online program called "Go! Foods for You (GFFY)" which is offered on the Cleveland Clinic's 360.5.com website. The research will last for 24 weeks. Questionnaire data and biometric measurements will be collected at pre and post intervention (0-8 weeks) and at followup (12 and 24 weeks). Regardless of randomization, participants will be asked to provide their weight every week and an activity log at the end of each week of the program. A urine sample to measure F2-isoprostane will be collected at week 0 and 12 for GFFY-2 and CTL groups.

A preparatory phase requiring the involvement of MAs to provide weekly support to participants is necessary to test process and communication with MAs. Enrollment of 10-20 volunteers for the preparatory phase is desired. Data collected during this phase will not be part of study analysis. To test data collection process, we may ask a few participants to complete baseline questionnaire only.

Tipo de estudo

Intervencional

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
        • Cleveland Clinic Foundation

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 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Body Mass Index (BMI) of 25 or greater.
  • Age 18 to 70 years old.
  • Patient of a participating Internal Medicine or Family Medicine primary care provider at a Cleveland Clinic Family Health Center.
  • Registered on the Cleveland Clinic's electric medical records, My Chart.

Exclusion Criteria:

  • Women who are pregnant or planning to be pregnant in the next 6 months.
  • No easy internet and email access at place of residence.
  • No access to a scale at place of residence for weekly weight measurement.
  • Sudden unintentional weight loss or weight gain in the past 3 months due to medical illness
  • Currently involved in a weight loss program
  • unwilling to be in the wait-list control group where participant will not have access to the program for 3 months
  • unwilling to log onto the internet on a regular basis for the duration of the study (3-4 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: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Control Group
No intervention provided. These participants will receive access to the Go! Foods for You program after the research trial has been completed (12 weeks after registration).
Comparador Ativo: GFFY-1 without weekly MA support
Utilization of the 8-week online nutrition program Go! Foods for You without weekly contact from staff at the medical provider's office.
Comportamental: Go! Foods for You without Weekly MA Support.
  • Participants access and utilize an 8-week online program which provides educational materials and weekly activities based on a Mediterranean diet and dietary "practices" that have been associated with healthy weights.
  • Each day participants receive educational materials related to the nutritional science of a Mediterranean diet. Each week (1) a new theme for the daily educational materials is presented and (2) participants are asked to schedule "activities" on a built in calendar and practice the activity throughout the week.
Comparador Ativo: GFFY-2 with weekly MA support
Utilization of the 8-week online nutrition program combined with weekly contact from the staff at the medical provider's office.
Comportamental: Go! Foods for You with Weekly MA Support.
  • Participants access and utilize an 8-week online program which provides educational materials and weekly activities based on a Mediterranean diet and dietary "practices" that have been associated with healthy weights.
  • In addition to the 8-week online program, participants receive weekly support by Medical Assistants (MA) over the phone or by email to establish a relationship and maintain program adherence by discussing the previous week's behavioral goals and setting weekly behavioral goals.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Weight Loss
Prazo: 12 weeks
To see if the 8-week Mediterranean diet online program (GFFY) can lead to weight loss at 12 week.
12 weeks
Effect of Weekly Communications on Adherence and Program Efficacy
Prazo: 12 weeks
To see if extension of the patient/medical provider relationship through weekly emails by a medical assistant who addresses the program behavioral goals set by the patient leads to greater weight loss.
12 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Effect on Oxidative Stress
Prazo: 12 weeks
To see if the program reduces bio markers of oxidative stress (F2 isoprostanes) for participants in the GFFY-2 compared to the CTL group.
12 weeks
Correlation between MA Support and Program Utilization
Prazo: 12 weeks
To see if participation in GFFY with MA support can improve program participation as measured by 8-week program completion rate and average weekly activities completed during the 8-week program.
12 weeks
Effect on Physical and Mental Health
Prazo: 12 weeks
To see if an 8-week Mediterranean diet online program help improve overall physical and mental health as measured by the RAND Corporation Health Survey tool (SF36Rand).
12 weeks
Sustainability of Weight Loss
Prazo: 24 weeks
To see if weight loss from participation in the GFFY programs is sustained at 24 weeks (6 months) follow-up.
24 weeks
Dietary Improvements
Prazo: 12 weeks
To see if participation in GFFY increases fiber intake, percentage fat and fruit and vegetable consumption as measured by a brief online food screening questionnaire
12 weeks
Increase in Intake of a Mediterranean-based Diet
Prazo: 12 weeks
To see if participation in GFFY increases intake of a Mediterranean based diet as measured by a short Mediterranean diet questionnaires.
12 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

The Cleveland Clinic

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 abril de 2012

Conclusão Primária (Real)

1 de agosto de 2012

Conclusão do estudo (Real)

1 de agosto de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

23 de setembro de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de fevereiro de 2012

Primeira postagem (Estimativa)

14 de fevereiro de 2012

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de maio de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de maio de 2022

Última verificação

1 de maio de 2022

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • IRB# 11-475

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