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Body Worlds 3 Nutrition Display

Primary Purpose

Obesity, Hyperlipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring dietary intake, genetic predisposition, body composition

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Oregon Health & Science University

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 28, 2008
Last Updated
September 27, 2011
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT00669500
Brief Title
Body Worlds 3 Nutrition Display
Official Title
Body Worlds 3 - Nutrition and College of Pharmacy Weeks Exhibit and Lifestyle Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hyperlipidemia
Keywords
dietary intake, genetic predisposition, body composition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3188 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention Description
Alive!TM web-based, 12 week lifestyle intervention sent via NutritionQuest.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Attendees of public health fairs General population Under the age of 18 Above the age of 18 Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jackilen Shannon, PhD
Organizational Affiliation
OHSU Center for Research on Occupational and Environmental Toxicology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Body Worlds 3 Nutrition Display

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