Communicating Multiple Disease Risks: A Translation of Risk Prediction Science

January 9, 2020 updated by: Washington University School of Medicine

Epidemiology seeks to improve public health by identifying risk factors for cancer and other diseases and conveying that information to relevant audiences (e.g., physicians, the public). The audience is presumed to understand and use that information to make appropriate decisions about lifestyle behaviors and medical treatments. Yet, even though a single risk factor can affect the risk of multiple health outcomes, this information is seldom communicated to people in a way that optimizes their understanding of the importance of engaging in a single healthy behavior. Providing individuals with the ability to understand how a single behavior (obtaining sufficient physical activity) could affect their risk of developing multiple diseases could foster a more coherent and meaningful picture of the behavior's importance in reducing health risks, increase motivation and intentions to engage in the behavior, and over time improve public health.

The proposed study translates epidemiological data about five diseases that cause significant morbidity and mortality (i.e., colon cancer, breast cancer (women), heart disease, diabetes, and stroke) into a visual display that conveys individualized risk estimates in a comprehensible, meaningful, and useful way to diverse lay audiences.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
554

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 30-64 years of age
  • Less than (3) relevant comorbidities (diabetes, heart disease, stroke, and cancer, where cancer counts as (2) comorbidities for women but (1) for men)
  • Having a SMS capable mobile phone that is not shared with anyone else

Exclusion Criteria:

  • Not meeting national guidelines for aerobic physical activity (i.e., at least 150 minutes per week of moderate intensity aerobic physical activity)
  • Participants from HRPO# 201501028 will be ineligible for this study
  • Uses text messaging less than once per month

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Risk Display Format:Risk Ladder:Imagery Behavior:Exercise
  • With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.
  • Participants take Baseline Survey 1.
  • Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks.
  • Participants take Baseline Survey 2.
  • Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).
  • Participants take surveys via text at the end of each week for 4 weeks.
  • 90 days post-baseline, participants complete a survey sent through the mail.
  • Participants may be contacted for another survey 1 year later.
Behavioral: Risk Assessment App
The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.
Other: Surveys
Assesses information comprehension, intentions, perceived risk and severity worry, self- efficacy, response efficacy, affect, race, education, age, numeracy, graph literacy, and exercise and sleep behaviors.
Behavioral: Audio Recording - Exercise
Participants imagine themselves improving exercise
Other: Text message reminders
-Reminders to practice mental imagery
Other: Text Message Survey
-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.
Experimental: Risk Display Format:Risk Ladder:Imagery Behavior:Sleep
  • With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.
  • Participants take Baseline Survey 1.
  • Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks.
  • Participants take Baseline Survey 2.
  • Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).
  • Participants take surveys via text at the end of each week for 4 weeks.
  • 90 days post-baseline, participants complete a survey sent through the mail.
  • Participants may be contacted for another survey 1 year later.
Behavioral: Risk Assessment App
The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.
Other: Surveys
Assesses information comprehension, intentions, perceived risk and severity worry, self- efficacy, response efficacy, affect, race, education, age, numeracy, graph literacy, and exercise and sleep behaviors.
Other: Text message reminders
-Reminders to practice mental imagery
Other: Text Message Survey
-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.
Behavioral: Audio Recording - Sleep
-Participants imagine themselves improving sleep hygiene
Experimental: Risk Display Format:Table:Imagery Behavior:Exercise
  • With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.
  • Participants take Baseline Survey 1.
  • Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks.
  • Participants take Baseline Survey 2.
  • Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).
  • Participants take surveys via text at the end of each week for 4 weeks.
  • 90 days post-baseline, participants complete a survey sent through the mail.
  • Participants may be contacted for another survey 1 year later.
Behavioral: Risk Assessment App
The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.
Other: Surveys
Assesses information comprehension, intentions, perceived risk and severity worry, self- efficacy, response efficacy, affect, race, education, age, numeracy, graph literacy, and exercise and sleep behaviors.
Behavioral: Audio Recording - Exercise
Participants imagine themselves improving exercise
Other: Text message reminders
-Reminders to practice mental imagery
Other: Text Message Survey
-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.
Experimental: Risk Display Format:Table: Imagery Behavior:Sleep
  • With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.
  • Participants take Baseline Survey 1.
  • Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks.
  • Participants take Baseline Survey 2.
  • Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).
  • Participants take surveys via text at the end of each week for 4 weeks.
  • 90 days post-baseline, participants complete a survey sent through the mail.
  • Participants may be contacted for another survey 1 year later.
Behavioral: Risk Assessment App
The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.
Other: Surveys
Assesses information comprehension, intentions, perceived risk and severity worry, self- efficacy, response efficacy, affect, race, education, age, numeracy, graph literacy, and exercise and sleep behaviors.
Other: Text message reminders
-Reminders to practice mental imagery
Other: Text Message Survey
-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.
Behavioral: Audio Recording - Sleep
-Participants imagine themselves improving sleep hygiene
Experimental: Risk Display Format:Text:Imagery Behavior:Exercise
  • With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.
  • Participants take Baseline Survey 1.
  • Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks.
  • Participants take Baseline Survey 2.
  • Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).
  • Participants take surveys via text at the end of each week for 4 weeks.
  • 90 days post-baseline, participants complete a survey sent through the mail.
  • Participants may be contacted for another survey 1 year later.
Behavioral: Risk Assessment App
The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.
Other: Surveys
Assesses information comprehension, intentions, perceived risk and severity worry, self- efficacy, response efficacy, affect, race, education, age, numeracy, graph literacy, and exercise and sleep behaviors.
Behavioral: Audio Recording - Exercise
Participants imagine themselves improving exercise
Other: Text message reminders
-Reminders to practice mental imagery
Other: Text Message Survey
-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.
Experimental: Risk Display Format:Text:Imagery Behavior:Sleep
  • With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise.
  • Participants take Baseline Survey 1.
  • Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks.
  • Participants take Baseline Survey 2.
  • Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks).
  • Participants take surveys via text at the end of each week for 4 weeks.
  • 90 days post-baseline, participants complete a survey sent through the mail.
  • Participants may be contacted for another survey 1 year later.
Behavioral: Risk Assessment App
The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.
Other: Surveys
Assesses information comprehension, intentions, perceived risk and severity worry, self- efficacy, response efficacy, affect, race, education, age, numeracy, graph literacy, and exercise and sleep behaviors.
Other: Text message reminders
-Reminders to practice mental imagery
Other: Text Message Survey
-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.
Behavioral: Audio Recording - Sleep
-Participants imagine themselves improving sleep hygiene

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise
Time Frame: Baseline and up to 90 days
Baseline and up to 90 days
Difference in Gist Comprehension of Risk Information by Risk Display Format
Time Frame: Baseline
  • Risk display format = risk ladder, table, or text
  • Gist comprehension of risk information: being able to extract the bottom-line meaning of information provided by the website (e.g., if exercising decreased heath risk)
  • Measured by the sum of (4) questions coded as correctly comprehending risk information (1 point) or incorrectly comprehending risk information (0 points), with a total score range of 0=low comprehension to 4=high comprehension. Higher comprehension is considered a better outcome.
  • All comprehension questions have an additional "don't know" option, which is counted as incorrect.
  • To limit participant burden, the investigators assessed comprehension for diabetes only, instead of all diseases as planned.
  • Comprehension will not be assessed for people who report a history of diabetes because they are not given risk information.
Baseline
Difference in Verbatim Comprehension of Risk Information by Risk Communication Strategy
Time Frame: Baseline
  • Risk communication strategy = risk ladder, table, or text
  • Verbatim comprehension of risk information: being able to recall the exact information specific to diabetes risk and hours of recommended weekly physical activity
  • Measured by the sum of (3) questions coded as correctly comprehending information (1 point) or incorrectly comprehending information (0 points), with a total score range of 0=low comprehension to 3=high comprehension. Higher comprehension is considered a better outcome.
  • All comprehension questions have an additional "don't know" option, which is counted as incorrect.
  • To limit participant burden, the investigators assessed comprehension for diabetes only, instead of all diseases as planned.
  • Comprehension will not be assessed for people who report a history of diabetes because they are not given risk information.
Baseline
Difference in Self-reported Intentions to Engage in Physical Activity by Risk Display Format
Time Frame: Baseline
  • Risk display format = risk ladder, table, or text
  • Self-reported physical activity intentions is defined as intentions to engage in physical activity in the next 3 months
  • Measured as an average of three variables, each measured on a 5 point Likert Scale (range: 1=lower intentions to 5=higher intentions)
  • Higher intentions are considered a better outcome
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect of the Intervention on Physical Activity Levels as Measured by Maintenance Self-efficacy
Time Frame: 90 days
  • Maintenance Self-efficacy is defined as being sure one can engage in physical activity even when it is hard
  • Measured on a 4 point Likert Scale (range: 1=lower Maintenance Self-efficacy to 4=higher Maintenance Self-efficacy)
  • Higher maintenance self-efficacy is considered a better outcome
  • Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items
90 days
Effect of the Intervention on Physical Activity Levels as Measured by Recovery Self-efficacy
Time Frame: 90 days
  • Recovery Self-efficacy is defined as being sure one can re-engage in physical activity after putting it off
  • Measured on a 4 point Likert Scale (range: 1=lower recovery Self-efficacy to 4=higher recovery Self-efficacy)
  • Higher recovery self-efficacy is considered a better outcome
  • Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items
90 days
Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Enjoying Behavior
Time Frame: 90 days
  • Affective Attitudes to Exercise - Enjoying Behavior is defined as thinking getting regular exercise is enjoyable
  • Measured on a 4 point Likert Scale (range: 1=lower Affective Attitudes to Exercise to 4=higher Affective Attitudes to Exercise)
  • Higher Affective Attitudes to Exercise - Enjoying Behavior is considered a better outcome
  • Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items
90 days
Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Thinking Behavior is Unpleasant
Time Frame: 90 days
  • Affective Attitudes to Exercise - Thinking Behavior is Unpleasant is defined as not thinking getting regular exercise is unpleasant
  • Measured on a 4 point Likert Scale (range: 1=lower Affective Attitudes to Exercise to 4=higher Affective Attitudes to Exercise)
  • Higher Affective Attitudes to Exercise - Thinking Behavior is Unpleasant is considered a better outcome
  • Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items
90 days
Effect of the Intervention on Physical Activity Levels as Measured by Perceived Vividness of Self-regulatory Imagery
Time Frame: 90 days
  • Perceived Vividness of Self-regulatory Imagery is defined as having clear and vivid images of steps towards getting physical activity
  • Measured as an average of two variables measured on a 4 point Likert Scale (range: 1=lower Perceived Vividness of Self-regulatory Imagery to 4=higher Perceived Vividness of Self-regulatory Imagery)
  • Higher Perceived Vividness of Self-regulatory Imagery is considered a better outcome
  • Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items
90 days
Effect of the Intervention on Physical Activity Levels as Measured by Action Planning
Time Frame: 90 days
  • Action planning is defined as having a detailed plan about getting adequate physical activity
  • Measured as an average of three variables measured on a 4 point Likert Scale (range: 1=lower action planning to 4=higher action planning)
  • Higher action planning is considered a better outcome
  • Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items
90 days
Effect of the Intervention on Physical Activity Levels as Measured by Coping Planning
Time Frame: 90 days
  • Coping planning is defined as having a detailed plan of solving problems that may prevent getting adequate physical activity
  • Measured on a 4 point Likert Scale (range: 1=lower Coping Planning to 4=higher Coping Planning)
  • Higher coping planning is considered a better outcome
  • Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items
90 days
Effect of the Intervention on Physical Activity Levels as Measured by Action Self-efficacy
Time Frame: 90 days
  • Action self-efficacy is defined as having the confidence to engage in physical activity
  • Measured on a 4 point Likert Scale (range: 1=lower Action Self-efficacy to 4=higher Action Self-efficacy)
  • Higher Action Self-efficacy is considered a better outcome
  • Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items
90 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erika Waters, MPH, Ph.D., Washington University School of Medicine

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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 3, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 3, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201706063
  • R01CA190391 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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