Effectiveness of an Eight Week Online Mediterranean Based Diet

This study has been withdrawn prior to enrollment.
(Online program required re-design)
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01532258
First received: September 23, 2011
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Go! Foods for You without Weekly MA Support.
Behavioral: Go! Foods for You with Weekly MA Support.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effectiveness of an Eight Week Online Mediterranean Based Diet in an Overweight or Obese Outpatient Primary Care Population

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To see if the 8-week Mediterranean diet online program (GFFY) can lead to weight loss at 12 week.

  • Effect of Weekly Communications on Adherence and Program Efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Effect on Oxidative Stress [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To see if the program reduces bio markers of oxidative stress (F2 isoprostanes) for participants in the GFFY-2 compared to the CTL group.

  • Correlation between MA Support and Program Utilization [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Effect on Physical and Mental Health [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Sustainability of Weight Loss [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    To see if weight loss from participation in the GFFY programs is sustained at 24 weeks (6 months) follow-up.

  • Dietary Improvements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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

  • Increase in Intake of a Mediterranean-based Diet [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To see if participation in GFFY increases intake of a Mediterranean based diet as measured by a short Mediterranean diet questionnaires.


Enrollment: 0
Study Start Date: April 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No 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).
Active Comparator: 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.
Behavioral: 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.
Active Comparator: 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.
Behavioral: 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532258

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01532258     History of Changes
Other Study ID Numbers: IRB# 11-475
Study First Received: September 23, 2011
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
BMI
Weight loss
Nutrition
Diet
Mediterranean diet
Online program
web-based program
Oxidative stress
F2 isoprostanes

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014