Effectiveness of an Eight Week Online Mediterranean Based Diet
Effectiveness of an Eight Week Online Mediterranean Based Diet in an Overweight or Obese Outpatient Primary Care Population
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Ohio
-
Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic Foundation
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: 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).
|
|
|
Aktivní komparátor: 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.
|
|
|
Aktivní komparátor: 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.
|
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Weight Loss
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Effect on Oxidative Stress
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- IRB# 11-475
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .