Effectiveness of an Eight Week Online Mediterranean Based Diet

NCT ID: NCT01532258

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-08-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Go! Foods for You without Weekly MA Support.

Intervention Type: BEHAVIORAL

• 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.

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.

Group Type: ACTIVE_COMPARATOR

Go! Foods for You with Weekly MA Support.

Intervention Type: BEHAVIORAL

• 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Linda Libertini

Research Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

IRB# 11-475

Identifier Type: -

Identifier Source: org_study_id