Body Worlds 3 Nutrition Display

September 27, 2011 updated by: Jackilen Shannon, Oregon Health and Science University

Body Worlds 3 - Nutrition and College of Pharmacy Weeks Exhibit and Lifestyle Intervention

Primary Aim # 1: Determine the willingness of the public to participate in an intervention trial - NutritionQuest's Alive!TM - available in a public forum.

Aim #1 Hypotheses: Less than 10% of individuals visiting the NutritionWeek site will register to participate in the Alive!TM Intervention; 70% of these individuals will complete the full intervention.

Primary Aim # 2: To determine among individuals enrolled in the Alive!TM intervention, changes in measurements of body composition from pre- to post-intervention.

Aim #2 Hypotheses: Participation in Alive!TM will result in positive changes in body composition, including reduction of body weight, percent body fat and blood LDL and an increase in blood HDL cholesterol.

Purposes:

Educate the public on the relationship between diet, weight and chronic disease
Collect data for future research
For participants of the Oregon Museum of Science and Industry (OMSI) portion of this study, we also provide a diet assessment and optional 3-month intervention

Recruitment:

Researchers will have a display at OMSI coincidental with the Body Worlds 3 exhibit and at local health fairs. Participants will be recruited from the attendees of the OMSI Body Worlds 3 exhibit as well as general OMSI visitors from July through October 2007 and from health fairs at later dates.

Subject procedures:

No identifiable information will be collected; only gender, year of birth, race and ethnicity are collected on any participant.

Subjects under age 18 can participate in any or all of the following: a brief online, touch-screen assessment of eating and physical activity (health screening for immediate, printed feedback), physiologic measurements (height, weight, hip and waist circumference, percent body fat, blood pressure).

Subjects who are age 18 and over can participate in any or all of the following: a brief online, touch-screen assessment of eating and physical activity (health screening for immediate, printed feedback), physiologic measurements (height, weight, hip and waist circumference, percent body fat, blood pressure), finger prick to assess blood glucose and lipid levels as well as DNA sample (mouthwash swish).

For participants of the OMSI portion of this study, adults may also choose to join a 3-month online lifestyle intervention (Alive!™). Participants who enroll in the 3-month intervention will receive 12 intervention messages over a 3-month period. Each of the messages will take about 5 to 10 minutes to read. At the end of this 3-month period, participants will receive a post-assessment health screening at the Oregon Health & Science University (OHSU) Clinical and Translational Research Center. This post-assessment will include completion of a diet and physical activity assessment, fasting blood measures of glucose and lipids, blood pressure, weight and height.

All visitors to the display area and all research subjects will be offered educational materials.

Instruments used, for OMSI participants only:

The Alive!TM lifestyle intervention is a web-based diet assessment program designed to help individuals evaluate their diet and make healthy changes via tailored e-mail correspondence. This program is operated by NutritionQuest out of Berkeley, California; utilizing the Block questionnaires, designed and validated over many years by Dr. Gladys Block, and now in use by researchers and health practitioners world-wide.

Data analysis:

De-identified data will be stored for future analyses and will be used in descriptive analyses to provide information on the distribution of body size variables and how they relate to reported dietary intake. DNA data from cheek cell samples will be linked by identification number to dietary intake and physiologic measures. Though de-identified, this data may still be used to identify genetic profiles of individuals with various physiologic parameters.

For OMSI participants only:

Alive!TM lifestyle intervention data will be used to determine predictors of change in physiologic and reported intake measures pre and post-intervention, using analysis of variance. At the time of analyses ALL data (including Alive!TM participant data) will be de-identified.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: Lifestyle intervention

Study Type

Interventional

Enrollment (Actual)

3188

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Oregon
  - Portland, Oregon, United States, 97239
    - Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Attendees of public health fairs
General population
Under the age of 18
Above the age of 18

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine the willingness of the public to participate in an intervention trial - NutritionQuest's Alive!TM - available in a public forum. Time Frame: pre-intervention	pre-intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine among individuals enrolled in the Alive!TM intervention, changes in measurements of body composition from pre- to post-intervention. Time Frame: pre- and post-intervention	pre- and post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

Principal Investigator: Jackilen Shannon, PhD, OHSU Center for Research on Occupational and Environmental Toxicology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

April 28, 2008

First Submitted That Met QC Criteria