HealthyNCT00458172
Lay Theories of Health in Young and Middle Aged American Adults
An observational study of Healthy, run by University of Michigan at 1 site in United States.
Trial summary
This study is the second empirical investigation in a series of studies, examining what everyday people believe that it means to be healthy. Part of this research also involves examining whether these lay theories of health vary according to various demographic classifications. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Assessment of beliefs and attitudes
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 302 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Sep 2007
- Phase
- Observational
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- English primary language
- U.S. residency (but not necessarily citizenship)
Who cannot join
- Only by age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study 1 of Lay Theories of Health: Conceptualizations of Physical, Mental, and Social Health in Young and Middle-Aged Adults
This study is the second empirical investigation in a series of studies, examining what everyday people believe that it means to be healthy. Part of this research also involves examining whether these lay theories of health vary according to various demographic classifications.
Read the detailed description
In the journal "Science," Engel (1977) proposed the term "biopsychosocial model" to recognize the social and psychological factors impacting health and illness. Psychologists have played a significant role in contributing to current evidence for this model, including understanding how individuals think about their health.
Work in this area has corresponded to work on the implicit theories of individuals, and how those implicit theories have an impact upon cognition, affect, and behavior. Implicit theories are mental constructions about specific phenomena which, while often elaborate in structure, content, and function, are not well articulated by those who hold them.
A failure to thoroughly investigate lay theories of health has implications for the biopsychosocial model of health and illness, which states that it is not only the knowledge of the physician, but also the beliefs of the patient, that have consequences for the patient's experience of health and illness. Research on individual beliefs regarding illness has been accumulating for some time, and it is becoming apparent that these beliefs have significant consequences for individual health behavior. However, current studies assessing lay theories regarding illness may be inadequate to achieving the goal of fully learning how lay theories have an impact upon health. The methodologies utilized rarely distinguish whether the implicit theories under study should be attributed to laypeople or to experts, and tend to assume that health and illness have perfect reciprocal correspondence with one another in the minds of laypeople. If researchers hope to understand laypeople's theories about health, exclusively investigating lay theories of illness will not suffice to answer the question.
The present series of studies seeks to investigate a number of unanswered questions in the existing literature on lay theories of health. In a Prestudy, we investigated how adult laypeople define what it is to be healthy through open-ended survey questions. At the present time (the focus of the current IRB application) we hope to have participants rate the importance of each of the previously-gathered items to their concept of health (Study 1). We will then present the most important items in pairs to a second sample, and ask those participants to rate how similar or dissimilar the items are to one another. From these ratings, we will determine the structure of lay theories of health through scaling procedures. After determining the structure of lay theories (e.g., in terms of dimensions), we will focus on developing a comprehensive measure of lay theories of health. We will at that time conduct a series of validation studies to determine whether and how these dimensions of lay theories differ from those of experts, do or do not correspond with existing constructs measuring well-being, and are utilized by laypeople in making health judgments and decisions (which will be reviewed and conducted at a later date).
- Conditions
- Healthy
- Being tested
- Assessment of beliefs and attitudes
- Keywords
- lay theories, health concepts, survey, internet research, Ideas about health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of beliefs and attitudesBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Principal investigator, Christina A. Downey, University of Michigan
- Investigators
- Christina A Downey, M.S., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458172
- Sponsor's protocol ID
- HUM00011805
- Status last verified
- Jul 2016
- First submitted
- 4 Apr 2007
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study 1 of Lay Theories of Health: Conceptualizations of Physical, Mental, and Social Health in Young and Middle-Aged Adults
- ClinicalTrials.gov ID
- NCT00458172
- Acronym / sponsor ID
- HUM00011805
- Conditions
- Healthy
- Keywords
- lay theories, health concepts, survey, internet research, Ideas about health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Study start
- Apr 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 9 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.
This study is the second empirical investigation in a series of studies, examining what everyday people believe that it means to be healthy. Part of this research also involves examining whether these lay theories of health vary according to various demographic classifications.
Detailed description
In the journal "Science," Engel (1977) proposed the term "biopsychosocial model" to recognize the social and psychological factors impacting health and illness. Psychologists have played a significant role in contributing to current evidence for this model, including understanding how individuals think about their health.
Work in this area has corresponded to work on the implicit theories of individuals, and how those implicit theories have an impact upon cognition, affect, and behavior. Implicit theories are mental constructions about specific phenomena which, while often elaborate in structure, content, and function, are not well articulated by those who hold them.
A failure to thoroughly investigate lay theories of health has implications for the biopsychosocial model of health and illness, which states that it is not only the knowledge of the physician, but also the beliefs of the patient, that have consequences for the patient's experience of health and illness. Research on individual beliefs regarding illness has been accumulating for some time, and it is becoming apparent that these beliefs have significant consequences for individual health behavior. However, current studies assessing lay theories regarding illness may be inadequate to achieving the goal of fully learning how lay theories have an impact upon health. The methodologies utilized rarely distinguish whether the implicit theories under study should be attributed to laypeople or to experts, and tend to assume that health and illness have perfect reciprocal correspondence with one another in the minds of laypeople. If researchers hope to understand laypeople's theories about health, exclusively investigating lay theories of illness will not suffice to answer the question.
The present series of studies seeks to investigate a number of unanswered questions in the existing literature on lay theories of health. In a Prestudy, we investigated how adult laypeople define what it is to be healthy through open-ended survey questions. At the present time (the focus of the current IRB application) we hope to have participants rate the importance of each of the previously-gathered items to their concept of health (Study 1). We will then present the most important items in pairs to a second sample, and ask those participants to rate how similar or dissimilar the items are to one another. From these ratings, we will determine the structure of lay theories of health through scaling procedures. After determining the structure of lay theories (e.g., in terms of dimensions), we will focus on developing a comprehensive measure of lay theories of health. We will at that time conduct a series of validation studies to determine whether and how these dimensions of lay theories differ from those of experts, do or do not correspond with existing constructs measuring well-being, and are utilized by laypeople in making health judgments and decisions (which will be reviewed and conducted at a later date).
Study design
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- English primary language
- U.S. residency (but not necessarily citizenship)
Key exclusion criteria (1 listed)
- Only by age
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 |
|---|---|---|
| Assessment of beliefs and attitudes | Behavioural | – |
Primary outcome
Not reported in the source record.
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 29 Jul 2016.
- Study website - please click link to participate in this 15-minute study now.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Christina A Downey, M.S. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Michigan 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 2 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 29 Jul 2016. 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.
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.
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 29 Jul 2016.