Can A Nutrition Education Immersion Program Foster Sustainable Improvements in Clinical Parameters Over Time?

Nutrition and Education Immersion program sponsored by WholeFoods, Inc. for their employees.

Study Overview

• Status: Completed
• Conditions: Behavior
• Intervention / Treatment: Behavioral: Immersion program

Detailed Description

An ongoing Nutrition and Education Immersion program is currently ongoing that is supported by Whole Foods, Inc. for their employees. Eighty employees have previously agreed to attend a one week nutrition education and immersion program October 14-21, 2017. This program will involve nutrition education seminars, exercise and support classes that they are scheduled to attend. All meals are provided. They will all be 100% plant based with low oil. All employees will complete a dietary survey at the beginning of the study. Clinical parameters will be tested at start and end of the program. The majority of the lectures are CME certified by Rush University.

All participants will be approached for participation on day one to allow for the collection of the data being obtained as part of the existing project. In addition to the data from the program, this project will include a lab draw for nutritional markers at baseline and at the end of the immersion program, a dietary survey, SF-36, and DASI at baseline. Participants will be contacted by phone at months 3 and 6 and will be asked to complete the dietary survey, SF-36, and DASI. In addition, self-reported weight will be collected, and occurrence of health events (hospitalizations, new diagnoses). This will end their participation.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health
    • Naples, Florida, United States, 34102-5332
      • Naples Beach Hotel and Golf Club

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18yrs or older
• all comers with and without cardiovascular disease risk factors
• are attending the one week lifestyle immersion program sponsored by Whole Foods

Exclusion Criteria:

-unwilling to provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutrition Education Immersion Program; Assessing if a one week lifestyle interventions can lead to long term health benefits.	Behavioral: Immersion program; Evaluate the impact of an already established one week long lifestyle immersion program sponsored by Whole Foods, Inc for their employees on anthropomorphic, clinical labs such as lipid levels, blood sugar and other markers of nutrition, quality of life and activity levels at baseline, at the end of the program and at 3 and 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Self Reported by participating subject	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mediterranean Diet Survey	Diet Survey which is a standardized survey used to access patient nutritional intake Minimum Score is 0 points and Maximum Score is 15 points	Up to 6 months
36 Item Short Form Survey	SF-36 Quality of Life questionnaire which is a set of generic, coherent and easily administered quality of life measures.	Up to 6 months
Duke Activity Status Index	DASI(Duke Activity Status Index) which is a 12 item questionnaire that utilizes self reported physical capacity to estimate peak metabolic equivalents and has been shown to be a valid measurement of functional capacity. Score is based on the sum of "yes" replies and a value is given.	Up to 6 months

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Whole Foods, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): April 18, 2018
• Study Completion (Actual): October 15, 2018

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Education
• Other Study ID Numbers: IRB201702439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No