Self-Affirmation: Construct Validity

August 27, 2021 updated by: National Cancer Institute (NCI)

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

Completed

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 Type

Observational

Enrollment (Actual)

3112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute (NCI), 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: William M Klein, Ph.D., National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2016

Primary Completion (Actual)

January 15, 2020

Study Completion (Actual)

August 27, 2021

Study Registration Dates

First Submitted

December 13, 2014

First Submitted That Met QC Criteria

December 13, 2014

First Posted (Estimate)

December 16, 2014

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

August 1, 2021

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.

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