NCT03320551

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

October 18, 2017

Last Update Submit

July 10, 2019

Conditions

Behavior

Keywords

Education

Outcome Measures

Primary Outcomes (1)

  • Weight

    Self Reported by participating subject

    Up to 6 months

Secondary Outcomes (3)

  • Mediterranean Diet Survey

    Up to 6 months

  • 36 Item Short Form Survey

    Up to 6 months

  • Duke Activity Status Index

    Up to 6 months

Study Arms (1)

Nutrition Education Immersion Program

EXPERIMENTAL

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

Behavioral: Immersion program

Interventions

Immersion programBEHAVIORAL

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

Nutrition Education Immersion Program

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • unwilling to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UF Health

Gainesville, Florida, 32610, United States

Location

Naples Beach Hotel and Golf Club

Naples, Florida, 34102-5332, United States

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Monica Aggarwal, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 25, 2017

Study Start

October 16, 2017

Primary Completion

April 18, 2018

Study Completion

October 15, 2018

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)