Effectiveness of an Eight Week Online Mediterranean Based Diet
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|ClinicalTrials.gov Identifier: NCT01532258|
Recruitment Status : Withdrawn (Online program required re-design)
First Posted : February 14, 2012
Last Update Posted : July 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Go! Foods for You without Weekly MA Support. Behavioral: Go! Foods for You with Weekly MA Support.||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of an Eight Week Online Mediterranean Based Diet in an Overweight or Obese Outpatient Primary Care Population|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
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.
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.
- Weight Loss [ Time Frame: 12 weeks ]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 ]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.
- Effect on Oxidative Stress [ Time Frame: 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.
- Correlation between MA Support and Program Utilization [ Time Frame: 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.
- Effect on Physical and Mental Health [ Time Frame: 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).
- Sustainability of Weight Loss [ Time Frame: 24 weeks ]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 ]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 ]To see if participation in GFFY increases intake of a Mediterranean based diet as measured by a short Mediterranean diet questionnaires.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532258
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|