Study Stopped
Online program required re-design
Effectiveness of an Eight Week Online Mediterranean Based Diet
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2012
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2011
CompletedFirst Posted
Study publicly available on registry
February 14, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedMay 11, 2022
May 1, 2022
4 months
September 23, 2011
May 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Weight Loss
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
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
Secondary Outcomes (6)
Effect on Oxidative Stress
12 weeks
Correlation between MA Support and Program Utilization
12 weeks
Effect on Physical and Mental Health
12 weeks
Sustainability of Weight Loss
24 weeks
Dietary Improvements
12 weeks
- +1 more secondary outcomes
Study Arms (3)
Control Group
NO INTERVENTIONNo 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).
GFFY-1 without weekly MA support
ACTIVE COMPARATORUtilization 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
ACTIVE COMPARATORUtilization of the 8-week online nutrition program combined with weekly contact from the staff at the medical provider's office.
Interventions
* 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.
* 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Coordinator
Study Record Dates
First Submitted
September 23, 2011
First Posted
February 14, 2012
Study Start
April 1, 2012
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
May 11, 2022
Record last verified: 2022-05