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

Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320551
• Other study ID #: IRB201702439
• Status: Completed
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: October 15, 2018

Study information

• Verified date: July 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: October 15, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior

Intervention

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

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida
United States	Naples Beach Hotel and Golf Club	Naples	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Whole Foods, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Self Reported by participating subject	Up to 6 months
Secondary	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
Secondary	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
Secondary	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