Risk Reduction BehaviorNCT02317367
Self-Affirmation: Construct Validity
An observational study of Risk Reduction Behavior, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: People respond differently when asked about their values. They also respond differently when they learn about how their actions affect their lives and health. Researchers want to learn more about these differences. This can help them improve public health messages. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Risk Reduction Behavior
- How many people
- 3,112 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2016to 27 Aug 2021
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Convenience sample of online panelists in Amazon's mTurk pool (female alcohol drinkers only for study 1; guidelines/fruit and vegetable consumption guidelines for study 3).Convenience sample of online panelists in Prolific's pool (males and females who do not meet physical activity for Study 2)
Who may be able to join
- Study 1:
- Amazon mTurk workers will be invited to participate if they are women over the age of 18. They will also be screened to meet alcohol consumption inclusion criteria. Women will be eligible to complete the study if they drink seven or more drinks per week (consistent with the alcohol consumption level the health message links to increased breast cancer risk (which is based on evidence in the extant breast cancer risk literature). If women report drinking 7 or more drinks in a sitting, they will be eligible regardless of how many times they drank in the past year. If they report drinking less than 7 drinks in a sitting, an average will be calculated to determine whether they meet inclusion criteria. For example, women who report drinking twice per week on average, and who drink an average of 4 drinks in a sitting, would be eligible for the study.
- Study 2:
- Prolific participants will be invited to take part in the study if they are over the age of 18. They will also be screened to meet fruit and vegetable consumption inclusion criteria. Individuals will be eligible to complete the study if they eat fewer than 5 servings of fruits and vegetables per day, on average (consistent with the consumption level the health message, and consistent with US consumption recommendations).
- Study 3:
- Amazon mTurk workers will be invited to participate if they are over the age of 18. They will also be screened to meet fruit and vegetable consumption inclusion criteria. Individuals will be eligible to complete the study if they eat fewer than 5 servings of fruits and vegetables per day, on average (consistent with the consumption level the health message, and consistent with US consumption recommendations).
Who cannot join
- Study1
- All men, and women who report a lower threshold of alcohol consumption, will be excluded.
- Study 2
- All individuals who report a higher threshold of physical activity will be excluded
- Study3
- All individuals who report a higher threshold of fruit and vegetable. consumption, will be excluded. All individuals who participated in Studies 1 and 2 will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- People respond differently when asked about their values. They also respond differently when they learn about how their actions affect their lives and health. Researchers want to learn more about these differences. This can help them improve public health messages.
Read more
Objective:
- To see how people respond differently to questions about their values and to information about alcohol and breast cancer.
Eligibility:
Study 1
- Women age 18 and older.
Study 2 \& Study 3
-Women and men aged 18 and older to take part in these studies if they do not meet the US recommendations of eating 5 or more servings of fruits and vegetables per week.
Design:
- This study will take place online.
- Participants will be randomly assigned to a group that will complete a certain task.
- Researchers will ask participants to complete 2 small studies:
- Values Study. Some participants may write briefly about a value that is important to them or to someone they are close to. Some participants will complete a short questionnaire instead of the writing exercise.
- Study 1:
Alcohol and Breast Cancer Study. Participants will read a health message. This will be about the link between alcohol use and increased breast cancer risk. Participants will then answer questions about what they read and their beliefs about alcohol and breast cancer.
-Study 2:
Fruit and Vegetable Consumption and Health Study. Participants will read a health message about the fruit and vegetable consumption. Participants will then answer questions about what they read and their beliefs about fruit and vegetable consumption.
-Study 3:
Fruit and Vegetable Consumption and Health Study. Participants will read a health message about the fruit and vegetable consumption. Participants will then answer questions about what they read and their beliefs about fruit and vegetable consumption. Complete a follow-up survey that will be emailed to you through the mTurk system a week after you complete the main study.
- Both studies in either Study 1, Study 2 and Study 3 should take about 30 minutes.
Read the detailed description
Self-affirmation, a process by which individuals reflect on cherished personal values is a potent means of augmenting the effectiveness of threatening health communications. Individuals tend to be defensive against information suggesting their behavior puts them at risk for disease or negative health. Previous evidence suggests that self-affirmation may reduce defensiveness to threatening health information, increasing openness to the message and resulting in increased disease risk perceptions, disease-related worry, intentions to engage in preventive behavior, and actual behavioral change. Understanding the mechanisms that explain these robust effects would yield evidence important for dissemination, including ways to refine self-affirmation interventions and make them more potent, which could change the ways that public health messages are constructed. Thus, we aim to elucidate potential mechanisms underlying the effectiveness of self-affirmation, including self-activation, general affirmation, and domain-specific affirmation. In study 1, female human subjects will be randomly assigned to one of eleven affirmation or self- activation conditions. Following the affirmation or activation task, subjects will read about the documented link between alcohol and breast cancer. Finally, they will be asked a series of questions about their intentions to reduce drinking, their perceived risk of breast cancer, and their worry about breast cancer. Study 2 will replicate study 1, but in a different behavioral domain (physical activity) and a different sample (both males and females who do not meet physical activity recommendations). Study 3 will extend Studies 1 and 2 by examining whether the most effective self-affirmations identified in these studies produce short-term increases in fruit and vegetable consumption. Drawing on previous research, we hypothesize these inductions will be effective to the degree that they involve a self-affirmation, but will not be effective if they involve only other-affirmation or self-activation.
- Conditions
- Risk Reduction Behavior
- Keywords
- Construct Validity, Self-Affirmation, Alcohol Consumption, Breast Cancer
- Medical subject headings
- Risk Reduction Behavior, Alcohol Drinking, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| adult women | Women who drink seven or more drinks per week | |
| adults a | Individuals who eat fewer than five servings of fruits and vegetables per day, on average, based on an NCI screener for fruit and vegetable consumption. | |
| adults b | Individuals who exercise (moderate or vigorous intensity) less than 75 minutes per week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intentions to reduce alcohol consumption
Intentions to reduce alcohol consumption
Measured: Immediately post-intervention
Intentions to increase physical activity
Intentions to increase physical activity
Measured: immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study start31 Jul 2016
- Primary completion15 Jan 2020
- Study completion27 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Risk Reduction BehaviorStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 3,112 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- William M Klein, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317367
- Sponsor's protocol ID
- 999915032
- Other IDs
- 15-C-N032
- Status last verified
- Aug 2021
- First submitted
- 13 Dec 2014
- Last updated
- 30 Aug 2021
- Results posted
- No
Publications
Crocker J, Niiya Y, Mischkowski D. Why does writing about important values reduce defensiveness? Self-affirmation and the role of positive other-directed feelings. Psychol Sci. 2008 Jul;19(7):740-7. doi: 10.1111/j.1467-9280.2008.02150.x.
PubMed 18727791
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Affirmation: Construct Validity
- ClinicalTrials.gov ID
- NCT02317367
- Acronym / sponsor ID
- 999915032
- Conditions
- Risk Reduction Behavior
- Keywords
- Construct Validity, Self-Affirmation, Alcohol Consumption, Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,112 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 31 Jul 2016 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 16 Dec 2014 (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.
Background:
- People respond differently when asked about their values. They also respond differently when they learn about how their actions affect their lives and health. Researchers want to learn more about these differences. This can help them improve public health messages.
Objective:
- To see how people respond differently to questions about their values and to information about alcohol and breast cancer.
Eligibility:
Study 1
- Women age 18 and older.
Study 2 \& Study 3
-Women and men aged 18 and older to take part in these studies if they do not meet the US recommendations of eating 5 or more servings of fruits and vegetables per week.
Design:
- This study will take place online.
- Participants will be randomly assigned to a group that will complete a certain task.
- Researchers will ask participants to complete 2 small studies:
- Values Study. Some participants may write briefly about a value that is important to them or to someone they are close to. Some participants will complete a short questionnaire instead of the writing exercise.
- Study 1:
Alcohol and Breast Cancer Study. Participants will read a health message. This will be about the link between alcohol use and increased breast cancer risk. Participants will then answer questions about what they read and their beliefs about alcohol and breast cancer.
-Study 2:
Fruit and Vegetable Consumption and Health Study. Participants will read a health message about the fruit and vegetable consumption. Participants will then answer questions about what they read and their beliefs about fruit and vegetable consumption.
-Study 3:
Fruit and Vegetable Consumption and Health Study. Participants will read a health message about the fruit and vegetable consumption. Participants will then answer questions about what they read and their beliefs about fruit and vegetable consumption. Complete a follow-up survey that will be emailed to you through the mTurk system a week after you complete the main study.
- Both studies in either Study 1, Study 2 and Study 3 should take about 30 minutes.
Detailed description
Self-affirmation, a process by which individuals reflect on cherished personal values is a potent means of augmenting the effectiveness of threatening health communications. Individuals tend to be defensive against information suggesting their behavior puts them at risk for disease or negative health. Previous evidence suggests that self-affirmation may reduce defensiveness to threatening health information, increasing openness to the message and resulting in increased disease risk perceptions, disease-related worry, intentions to engage in preventive behavior, and actual behavioral change. Understanding the mechanisms that explain these robust effects would yield evidence important for dissemination, including ways to refine self-affirmation interventions and make them more potent, which could change the ways that public health messages are constructed. Thus, we aim to elucidate potential mechanisms underlying the effectiveness of self-affirmation, including self-activation, general affirmation, and domain-specific affirmation. In study 1, female human subjects will be randomly assigned to one of eleven affirmation or self- activation conditions. Following the affirmation or activation task, subjects will read about the documented link between alcohol and breast cancer. Finally, they will be asked a series of questions about their intentions to reduce drinking, their perceived risk of breast cancer, and their worry about breast cancer. Study 2 will replicate study 1, but in a different behavioral domain (physical activity) and a different sample (both males and females who do not meet physical activity recommendations). Study 3 will extend Studies 1 and 2 by examining whether the most effective self-affirmations identified in these studies produce short-term increases in fruit and vegetable consumption. Drawing on previous research, we hypothesize these inductions will be effective to the degree that they involve a self-affirmation, but will not be effective if they involve only other-affirmation or self-activation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| adult women | – | –Women who drink seven or more drinks per week |
| adults a | – | –Individuals who eat fewer than five servings of fruits and vegetables per day, on average, based on an NCI screener for fruit and vegetable consumption. |
| adults b | – | –Individuals who exercise (moderate or vigorous intensity) less than 75 minutes per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Convenience sample of online panelists in Amazon's mTurk pool (female alcohol drinkers only for study 1; guidelines/fruit and vegetable consumption guidelines for study 3).Convenience sample of online panelists in Prolific's pool (males and females who do not meet physical activity for Study 2)
Key inclusion criteria (6 listed)
- Amazon mTurk workers will be invited to participate if they are women over the age of 18. They will also be screened to meet alcohol consumption inclusion criteria. Women will be eligible to complete the study if they drink seven or more drinks per week (consistent with the alcohol consumption level the health message links to increased breast cancer risk (which is based on evidence in the extant breast cancer risk literature). If women report drinking 7 or more drinks in a sitting, they will be eligible regardless of how many times they drank in the past year. If they report drinking less than 7 drinks in a sitting, an average will be calculated to determine whether they meet inclusion criteria. For example, women who report drinking twice per week on average, and who drink an average of 4 drinks in a sitting, would be eligible for the study.
- Prolific participants will be invited to take part in the study if they are over the age of 18. They will also be screened to meet fruit and vegetable consumption inclusion criteria. Individuals will be eligible to complete the study if they eat fewer than 5 servings of fruits and vegetables per day, on average (consistent with the consumption level the health message, and consistent with US consumption recommendations).
- Amazon mTurk workers will be invited to participate if they are over the age of 18. They will also be screened to meet fruit and vegetable consumption inclusion criteria. Individuals will be eligible to complete the study if they eat fewer than 5 servings of fruits and vegetables per day, on average (consistent with the consumption level the health message, and consistent with US consumption recommendations).
Key exclusion criteria (6 listed)
- Study1
- All men, and women who report a lower threshold of alcohol consumption, will be excluded.
- Study 2
- All individuals who report a higher threshold of physical activity will be excluded
- Study3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intentions to reduce alcohol consumption
Time frame: Immediately post-intervention
Intentions to reduce alcohol consumption
Intentions to increase physical activity
Time frame: immediately post-intervention
Intentions to increase physical activity
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 30 Aug 2021.
- Background: PubMed 18727791Crocker J, Niiya Y, Mischkowski D. Why does writing about important values reduce defensiveness? Self-affirmation and the role of positive other-directed feelings. Psychol Sci. 2008 Jul;19(7):740-7. doi: 10.1111/j.1467-9280.2008.02150.x.
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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.
William M Klein, Ph.D. principal investigator
National Cancer Institute (NCI)
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 Risk Reduction Behavior, run by National Cancer Institute (NCI) 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 6 inclusion and 6 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 30 Aug 2021. 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.
What does the primary outcome measure?
Intentions to reduce alcohol consumption (time frame: Immediately post-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?
On the ClinicalTrials.gov record for NCT02317367, which also lists 1 linked publication.
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 30 Aug 2021.