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OpenTrials
Completed

NCT Number: NCT03320551

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.

Completed

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immersion program

Behavioral

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

Primary outcomes

  1. Weight

    Time frame: Up to 6 months

    Self Reported by participating subject

Secondary outcomes

  1. Mediterranean Diet Survey

    Time frame: Up to 6 months

    Diet Survey which is a standardized survey used to access patient nutritional intake Minimum Score is 0 points and Maximum Score is 15 points

  2. 36 Item Short Form Survey

    Time frame: Up to 6 months

    SF-36 Quality of Life questionnaire which is a set of generic, coherent and easily administered quality of life measures.

  3. Duke Activity Status Index

    Time frame: Up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Whole Foods, Inc.

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 25, 2017
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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