Effectiveness of an Eight Week Online Mediterranean Based Diet

Not Applicable

Withdrawn

• Conditions: Obesity
• Interventions: Behavioral: Go! Foods for You without Weekly MA Support.; Behavioral: Go! Foods for You with Weekly MA Support.

• Registration Number: NCT01532258
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2011-09-23
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-14
• Study Start: 2012-04
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GFFY-1 without weekly MA support	Go! Foods for You 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.
GFFY-2 with weekly MA support	Go! Foods for You 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.

Primary Outcome Measures

Name	Time	Method
Effect of Weekly Communications on Adherence and Program Efficacy	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.
Weight Loss	12 weeks	To see if the 8-week Mediterranean diet online program (GFFY) can lead to weight loss at 12 week.

Secondary Outcome Measures

Name	Time	Method
Dietary Improvements	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	12 weeks	To see if participation in GFFY increases intake of a Mediterranean based diet as measured by a short Mediterranean diet questionnaires.
Effect on Oxidative Stress	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	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.
Sustainability of Weight Loss	24 weeks	To see if weight loss from participation in the GFFY programs is sustained at 24 weeks (6 months) follow-up.
Effect on Physical and Mental Health	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).

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States