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OpenTrials
Completed

NCT Number: NCT00669500

Body Worlds 3 Nutrition Display

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:

1. Educate the public on the relationship between diet, weight and chronic disease 2. Collect data for future research 3. 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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Lifestyle Intervention

Behavioral

Alive!TM web-based, 12 week lifestyle intervention sent via NutritionQuest.

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 30, 2008
Registry last updated
Sep 28, 2011

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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