Clinical trial NCT01532258: Effectiveness of an Eight Week Online Mediterranean Based Diet
Official title: Effectiveness of an Eight Week Online Mediterranean Based Diet in an Overweight or Obese Outpatient Primary Care Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Keywords: BMI
Weight loss
Nutrition
Diet
Mediterranean diet
Online program
web-based program
Oxidative stress
F2 isoprostanes
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2012-02-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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)

Primary outcomes:
measure: Weight Loss
timeFrame: 12 weeks
measure: Effect of Weekly Communications on Adherence and Program Efficacy
timeFrame: 12 weeks
Secondary outcomes:
measure: Effect on Oxidative Stress
timeFrame: 12 weeks
measure: Correlation between MA Support and Program Utilization
timeFrame: 12 weeks
measure: Effect on Physical and Mental Health
timeFrame: 12 weeks
measure: Sustainability of Weight Loss
timeFrame: 24 weeks
measure: Dietary Improvements
timeFrame: 12 weeks
measure: Increase in Intake of a Mediterranean-based Diet
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
References: