NCT02317367

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,112

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 16, 2014

Completed
1.6 years until next milestone

Study Start

First participant enrolled

July 31, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

3.5 years

First QC Date

December 13, 2014

Last Update Submit

August 27, 2021

Conditions

Keywords

Construct ValiditySelf-AffirmationAlcohol ConsumptionBreast Cancer

Outcome Measures

Primary Outcomes (2)

  • Intentions to reduce alcohol consumption

    Intentions to reduce alcohol consumption

    Immediately post-intervention

  • Intentions to increase physical activity

    Intentions to increase physical activity

    immediately post-intervention

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • Study 1:
  • Study 2:
  • Study 3:

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • 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.

    PMID: 18727791BACKGROUND

MeSH Terms

Conditions

Risk Reduction BehaviorAlcohol DrinkingBreast Neoplasms

Condition Hierarchy (Ancestors)

BehaviorDrinking BehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • William M Klein, Ph.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2014

First Posted

December 16, 2014

Study Start

July 31, 2016

Primary Completion

January 15, 2020

Study Completion

August 27, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Locations