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Effectiveness of an Eight Week Online Mediterranean Based Diet

6. mai 2022 oppdatert av: 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.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic Foundation

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: 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).
Aktiv 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.
Atferdsmessig: 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.
Aktiv 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Weight Loss
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Effect on Oxidative Stress
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Cleveland Clinic

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2012

Primær fullføring (Faktiske)

1. august 2012

Studiet fullført (Faktiske)

1. august 2012

Datoer for studieregistrering

Først innsendt

23. september 2011

Først innsendt som oppfylte QC-kriteriene

9. februar 2012

Først lagt ut (Anslag)

14. februar 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mai 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. mai 2022

Sist bekreftet

1. mai 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • IRB# 11-475

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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