Body Worlds 3 Nutrition Display
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|ClinicalTrials.gov Identifier: NCT00669500|
Recruitment Status : Completed
First Posted : April 30, 2008
Last Update Posted : September 28, 2011
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.
- 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
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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Hyperlipidemia||Behavioral: Lifestyle intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3188 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Body Worlds 3 - Nutrition and College of Pharmacy Weeks Exhibit and Lifestyle Intervention|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
Behavioral: Lifestyle intervention
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669500
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Jackilen Shannon, PhD||OHSU Center for Research on Occupational and Environmental Toxicology|