Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
3188 participants
INTERVENTIONAL
2007-07-31
2008-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lifestyle intervention
Alive!TM web-based, 12 week lifestyle intervention sent via NutritionQuest.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* General population
* Under the age of 18
* Above the age of 18
Exclusion Criteria
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oregon Health and Science University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jackilen Shannon
PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jackilen Shannon, PhD
Role: PRINCIPAL_INVESTIGATOR
OHSU Center for Research on Occupational and Environmental Toxicology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oregon Health & Science University
Portland, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OHSU eIRB3694
Identifier Type: -
Identifier Source: org_study_id