Effectiveness of an Eight Week Online Mediterranean Based Diet
6. Mai 2022 aktualisiert von: 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.
Studienübersicht
Status
Zurückgezogen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Ohio
-
Cleveland, Ohio, Vereinigte Staaten, 44195
- Cleveland Clinic Foundation
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: 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).
|
|
|
Aktiver Komparator: 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.
|
|
|
Aktiver Komparator: 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.
|
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Weight Loss
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Effect on Oxidative Stress
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. April 2012
Primärer Abschluss (Tatsächlich)
1. August 2012
Studienabschluss (Tatsächlich)
1. August 2012
Studienanmeldedaten
Zuerst eingereicht
23. September 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Februar 2012
Zuerst gepostet (Schätzen)
14. Februar 2012
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
11. Mai 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
6. Mai 2022
Zuletzt verifiziert
1. Mai 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- IRB# 11-475
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .