OsteoporosisPhase 1NCT00464412
The Effect of a Short Educational Program on Young Women's Knowledge and Beliefs About Osteoporosis
A Phase 1 study testing Education in people with Osteoporosis, run by Valdosta State University.
Trial summary
The purpose of the study is to determine the effect of a short educational program on young women's knowledge and beliefs about osteoporosis. They hypothesis is that following the intervention women who receive the educational program will have greater knowledge and beliefs about osteoporosis. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Feb 2006
- Phase
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women enrolled in a mid-atlantic college physical activity course
Who cannot join
- Unable to partake in three survey's and one educational lesson
About this study
The purpose of the study is to determine the effect of a short educational program on young women's knowledge and beliefs about osteoporosis. They hypothesis is that following the intervention women who receive the educational program will have greater knowledge and beliefs about osteoporosis.
Read the detailed description
Objective. To determine the effect of a short osteoporosis educational program on young women's knowledge and beliefs about osteoporosis. Methods. Ten college physical activity classes enrolling 133 predominantly Caucasian women (age range 18 to 21 years) were randomized to an osteoporosis educational program or control. Knowledge and beliefs about osteoporosis were assessed at baseline and at one week and three weeks following the intervention using the Multiple Osteoporosis Prevention Survey. Knowledge was defined as the ability to identify correctly osteoporosis risk factors. Beliefs were measured with the use of a five point Likert type scale. The educational program was comprised of a lecture and printed materials developed by the National Osteoporosis Foundation. Chi-square and analysis of variance evaluated for between group differences. Alpha was set at 0.05.
- Conditions
- Osteoporosis
- Being tested
- Education
- Keywords
- Osteoporosis, Knowledge, Beliefs, Education, Women
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoporosis Knowledge
Measured: 7 days and 21 days post educational intervention
Osteoporosis Beliefs
Measured: 7 days and 21 days post educational intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2007 (estimated)
- Study startJan 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valdosta State University
- Sponsor type
- University, hospital or other
- Collaborators
- Roanoke College
- Investigators
- Mark J Kasper, EdD, Principal investigator, Valdosta State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464412
- Sponsor's protocol ID
- 1-Kasper
- Status last verified
- May 2007
- First submitted
- 19 Apr 2007
- Last updated
- 9 May 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Short Educational Program on Young Women's Knowledge and Beliefs About Osteoporosis
- ClinicalTrials.gov ID
- NCT00464412
- Acronym / sponsor ID
- 1-Kasper
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Knowledge, Beliefs, Education, Women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Valdosta State UniversityUniversity, hospital or other
- Collaborators
- Roanoke College
- Study start
- Jan 2006
- Study completion
- Feb 2006 (actual)
- First posted
- 23 Apr 2007 (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.
The purpose of the study is to determine the effect of a short educational program on young women's knowledge and beliefs about osteoporosis. They hypothesis is that following the intervention women who receive the educational program will have greater knowledge and beliefs about osteoporosis.
Detailed description
Objective. To determine the effect of a short osteoporosis educational program on young women's knowledge and beliefs about osteoporosis. Methods. Ten college physical activity classes enrolling 133 predominantly Caucasian women (age range 18 to 21 years) were randomized to an osteoporosis educational program or control. Knowledge and beliefs about osteoporosis were assessed at baseline and at one week and three weeks following the intervention using the Multiple Osteoporosis Prevention Survey. Knowledge was defined as the ability to identify correctly osteoporosis risk factors. Beliefs were measured with the use of a five point Likert type scale. The educational program was comprised of a lecture and printed materials developed by the National Osteoporosis Foundation. Chi-square and analysis of variance evaluated for between group differences. Alpha was set at 0.05.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women enrolled in a mid-atlantic college physical activity course
Key exclusion criteria (1 listed)
- Unable to partake in three survey's and one educational lesson
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 |
|---|---|---|
| Education | Behavioural | – |
Primary outcome
Osteoporosis Knowledge
Time frame: 7 days and 21 days post educational intervention
Osteoporosis Beliefs
Time frame: 7 days and 21 days post educational intervention
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 9 May 2007.
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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.
Mark J Kasper, EdD principal investigator
Valdosta State University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Education in people with Osteoporosis, run by Valdosta State University.
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 1 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 9 May 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Osteoporosis Knowledge (time frame: 7 days and 21 days post educational intervention). The study lists 2 primary outcomes in all. 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 9 May 2007.