- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00808574
Screening for Obstructive Sleep Apnea Among Members of an Internet Weight Loss Community
December 12, 2008 updated by: The University of Texas Health Science Center, Houston
Effect of a Web-Based Presentation on Communication With Healthcare Providers
The current study was a pilot, double blind, randomized controlled trial to (1) evaluate the feasibility of an online obstructive sleep apnea (OSA) screening intervention, (2) estimate effect size for planning of future studies, and (3) test the hypothesis that the intervention, compared to a control condition, would lead more individuals to discuss OSA with their healthcare provider.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
168
Phase
- Early Phase 1
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
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas Medical School, Houston
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Member of SparkPeople.com community and logged on within previous month
- Live in the US
Exclusion Criteria:
- Prior diagnosis of OSA
- Prior discussions with healthcare provider about OSA
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: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Brief, theory-based, online assessment of OSA risk followed by risk-tailed OSA presentation.
|
Brief, theory-based, online assessment of OSA risk followed by risk-tailed OSA presentation.
|
No Intervention: Control
No risk assessment or presentation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Online questionnaire asking whether subject has discussed OSA with healthcare provider since enrolling in study
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Online questionnaire asking whether subject has plans to discuss OSA with healthcare provider, if not done already
Time Frame: 12 weeks
|
12 weeks
|
Online questionnaire asking whether subject has undergone testing and treatment for OSA since enrolling in study
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kevin O Hwang, MD, MPH, University of Texas Medical School, Houston
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, 2008
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
December 12, 2008
First Submitted That Met QC Criteria
December 12, 2008
First Posted (Estimate)
December 16, 2008
Study Record Updates
Last Update Posted (Estimate)
December 16, 2008
Last Update Submitted That Met QC Criteria
December 12, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-08-0346
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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