Skip to main content
OpenTrials
Completed

NCT Number: NCT03255291

Communicating Multiple Disease Risks: A Translation of Risk Prediction Science

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

30 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risk Assessment App

Behavioral

The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.

Audio Recording - Sleep

Behavioral

-Participants imagine themselves improving sleep hygiene

Surveys

Other

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.

Audio Recording - Exercise

Behavioral

Participants imagine themselves improving exercise

Text message reminders

Other

-Reminders to practice mental imagery

Text Message Survey

Other

-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.

Primary outcomes

  1. Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise

    Time frame: Baseline and up to 90 days

  2. 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.

  3. 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.

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2017
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.