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Effectiveness of an Eight Week Online Mediterranean Based Diet

6 mai 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Retiré

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Ohio
      • Cleveland, Ohio, États-Unis, 44195
        • Cleveland Clinic Foundation

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: 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).
Comparateur actif: 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.
Comportemental: 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.
Comparateur actif: 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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Weight Loss
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Effect on Oxidative Stress
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The Cleveland Clinic

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2012

Achèvement primaire (Réel)

1 août 2012

Achèvement de l'étude (Réel)

1 août 2012

Dates d'inscription aux études

Première soumission

23 septembre 2011

Première soumission répondant aux critères de contrôle qualité

9 février 2012

Première publication (Estimation)

14 février 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 mai 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 mai 2022

Dernière vérification

1 mai 2022

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • IRB# 11-475

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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