- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02317367
Self-Affirmation: Construct Validity
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI), 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
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).
EXCLUSION CRITERIA:
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intentions to reduce alcohol consumption
Time Frame: Immediately post-intervention
|
Intentions to reduce alcohol consumption
|
Immediately post-intervention
|
|
Intentions to increase physical activity
Time Frame: immediately post-intervention
|
Intentions to increase physical activity
|
immediately post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William M Klein, Ph.D., National Cancer Institute (NCI)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 999915032
- 15-C-N032
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.
Clinical Trials on Risk Reduction Behavior
-
University of California, San FranciscoNational Institute of Allergy and Infectious Diseases (NIAID); University of... and other collaboratorsCompletedRisk ReductionSouth Africa
-
University of California, San FranciscoUniversity of MiamiCompletedRisk ReductionUnited States
-
University of California, San FranciscoNational Institute of Allergy and Infectious Diseases (NIAID); University of... and other collaboratorsCompleted
-
Hadassah Medical OrganizationCompletedHealth Behavior | Food Habits | Lifestyle Risk ReductionIsrael
-
Colorado State UniversityUniversity of Colorado, Denver; United States Department of Agriculture (USDA) and other collaboratorsRecruitingMental Health Wellness | Lifestyle Risk Reduction | Family ResearchUnited States
-
Istituto per la Ricerca e l'Innovazione BiomedicaFondazione Don Carlo Gnocchi Onlus; Universita degli Studi di Palermo; Medilink...RecruitingHealth Promotion | Life Style, Healthy | Risk ReductionItaly
-
National Taiwan University HospitalCompletedLifestyle Risk Reduction | Elderly Adults | Community DwellingTaiwan
-
Hadassah Medical OrganizationHebrew University of JerusalemNot yet recruitingHealth Behavior | Food Habits | Lifestyle Risk Reduction
-
University of California, San FranciscoUniversity of California, Berkeley; National Institute of Environmental Health... and other collaboratorsCompletedRisk Reduction | Children, Only | Environmental ExposureUnited States
-
University of PittsburghNational Institute of Environmental Health Sciences (NIEHS)RecruitingAsthma Exacerbation | Childhood Asthma | Air Pollution, Risk Reduction Behaviors | Asthma ControlUnited States