Processing Health InformationEarly Phase 1NCT00775008
Media Effects Study on Health-Related Content
A Early Phase 1 study testing electronic health information in people with Processing Health Information, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
A media lab study will be conducted to determine the mechanism by which podcasting may exert an effect. This study will examine both physiological (heart rate, skin conductance, etc.) and psychosocial (knowledge, perceived control, elaboration, etc.) measures in participants listening to a podcast on health versus… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Processing Health Information
- What is being tested?
- electronic health information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Nov 2008
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Be willing to be randomized to either the podcast or Web condition
- Able to attend the intervention session
Who cannot join
- Not living in the Chapel Hill area
Trial locations and contacts
1 site in 1 country.
About this study
A media lab study will be conducted to determine the mechanism by which podcasting may exert an effect. This study will examine both physiological (heart rate, skin conductance, etc.) and psychosocial (knowledge, perceived control, elaboration, etc.) measures in participants listening to a podcast on health versus reading health content on the Web. We hypothesize that podcasting will create a greater physiological response than the Web. There will also be more elaboration in the podcasting group. Podcasting will produce greater feelings of control. Changes in knowledge will be greater in the Web group.
- Conditions
- Processing Health Information
- Being tested
- electronic health information
- Keywords
- weight loss, health information, e-health
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic health informationBehavioural
Participants will receive weight loss information via 1 of 2 different mediums.
| Study group | Role | What they receive |
|---|---|---|
| podcast | Experimental | Not described Receives: Behavioral: electronic health information |
| Web group | Active comparator | Not described Receives: Behavioral: electronic health information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological response
Measured: 1 hour
Secondary outcomes (1)
Psychosocial response
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Processing Health InformationStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775008
- Sponsor's protocol ID
- 07-0430-02
- Status last verified
- Mar 2009
- First submitted
- 15 Oct 2008
- Last updated
- 3 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Media Effects Study on Health-Related Content
- ClinicalTrials.gov ID
- NCT00775008
- Acronym / sponsor ID
- 07-0430-02
- Conditions
- Processing Health Information
- Keywords
- weight loss, health information, e-health
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A media lab study will be conducted to determine the mechanism by which podcasting may exert an effect. This study will examine both physiological (heart rate, skin conductance, etc.) and psychosocial (knowledge, perceived control, elaboration, etc.) measures in participants listening to a podcast on health versus reading health content on the Web. We hypothesize that podcasting will create a greater physiological response than the Web. There will also be more elaboration in the podcasting group. Podcasting will produce greater feelings of control. Changes in knowledge will be greater in the Web group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| podcast | Experimental | Behavioral: electronic health information |
| Web group | Active comparator | Behavioral: electronic health information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Be willing to be randomized to either the podcast or Web condition
- Able to attend the intervention session
Key exclusion criteria (1 listed)
- Not living in the Chapel Hill area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic health informationParticipants will receive weight loss information via 1 of 2 different mediums. | Behavioural | Web group, podcast |
Primary outcome
Physiological response
Time frame: 1 hour
1 secondary outcome
Psychosocial response
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing electronic health information in people with Processing Health Information, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological response (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2009.