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CompletedNCT03320551Updated Jul 11, 2019

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

An interventional study of Immersion program in Behavior, sponsored by University of Florida. Completed at 2 sites in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-11.

Sponsored by University of Florida · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Behavior

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Keywords

  • Education
03

In context

Behavior

1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.

This study's enrollment of 73 is below the median of 120 across 1,197 interventional studies indexed under Behavior.

Browse Behavior studies →

Lead sponsor

University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

-unwilling to provide consent

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
73 participants (actual)

Study arms

  • Experimental
    Nutrition Education Immersion Program

    Assessing if a one week lifestyle interventions can lead to long term health benefits.

    Behavioral: Immersion program

Interventions

  • BehavioralImmersion 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

06

What researchers measure

Primary outcomes

  1. Weight

    Self Reported by participating subject

    Time frame: Up to 6 months

Secondary outcomes

  1. 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

    Time frame: Up to 6 months

  2. 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.

    Time frame: Up to 6 months

  3. 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.

    Time frame: Up to 6 months

07

Study locations

2 sites
  • UF Health
    Gainesville, Florida 32610, United States
  • Naples Beach Hotel and Golf Club
    Naples, Florida 34102-5332, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03320551
Collaborators
Whole Foods, Inc.
Responsible party
Sponsor
First posted
Oct 25, 2017
Start date
Oct 16, 2017
Primary completion
Apr 18, 2018
Completion
Oct 15, 2018
Last update
Jul 11, 2019

Study contacts

Monica Aggarwal, MD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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