NCT03255291

Communicating Multiple Disease Risks: A Translation of Risk Prediction Science

Completed NA Results posted Last updated 18 January 2020

What this trial tests

NA trial testing Risk Assessment App in Healthy Volunteers in 554 participants. Completed in 3 January 2019.

Timeline

27 June 2017

Primary endpoint
3 January 2019

3 January 2019

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	prevention
Enrollment	554
Start date	27 June 2017
Primary completion	3 January 2019
Estimated completion	3 January 2019
Sites	1 location across United States

Drugs / interventions tested

• Risk Assessment App
• Audio Recording - Sleep
• Surveys
• Audio Recording - Exercise
• Text message reminders
• Text Message Survey

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Washington University School of Medicine

Who can join

Adults 30 to 64, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise Primary · Baseline and up to 90 days

Group	Value	95% CI
Risk Display Format:Risk Ladder:Imagery Behavior:Exercise	92.2	± 12.7
Risk Display Format:Risk Ladder:Imagery Behavior:Sleep	37.5	± 13.4
Risk Display Format:Table:Imagery Behavior:Exercise	63.1	± 12.4
Risk Display Format:Table: Imagery Behavior:Sleep	60.0	± 12.9
Risk Display Format:Text:Imagery Behavior:Exercise	50.1	± 12.5
Risk Display Format:Text:Imagery Behavior:Sleep	49.3	± 13.0

Difference in Gist Comprehension of Risk Information by Risk Display Format Primary · 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 incor

Group	Value	95% CI
Risk Display Format: Risk Ladder	3.6	± 0.1
Risk Display Format: Table	3.4	± 0.1
Risk Display Format: Text	3.2	± 0.1

Difference in Verbatim Comprehension of Risk Information by Risk Communication Strategy Primary · 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. *

Group	Value	95% CI
Risk Display Format: Risk Ladder	1.6	± 0.1
Risk Display Format: Table	1.6	± 0.1
Risk Display Format: Text	1.5	± 0.1

Difference in Self-reported Intentions to Engage in Physical Activity by Risk Display Format Primary · 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

Group	Value	95% CI
Risk Display Format: Risk Ladder	3.9	± 0.1
Risk Display Format: Table	4.0	± 0.1
Risk Display Format: Text	3.8	± 0.1

Effect of the Intervention on Physical Activity Levels as Measured by Maintenance Self-efficacy Secondary · 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

Group	Value	95% CI
Mental Imagery Behavior: Exercise	2.95	± 0.05

Effect of the Intervention on Physical Activity Levels as Measured by Recovery Self-efficacy Secondary · 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

Group	Value	95% CI
Mental Imagery Behavior: Exercise	3.26	± 0.05

Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Enjoying Behavior Secondary · 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

Group	Value	95% CI
Mental Imagery Behavior: Exercise	3.05	± 0.05

Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Thinking Behavior is Unpleasant Secondary · 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

Group	Value	95% CI
Mental Imagery Behavior: Exercise	3.19	± 0.05

Effect of the Intervention on Physical Activity Levels as Measured by Perceived Vividness of Self-regulatory Imagery Secondary · 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

Group	Value	95% CI
Mental Imagery Behavior: Exercise	3.36	± 0.04

Effect of the Intervention on Physical Activity Levels as Measured by Action Planning Secondary · 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

Group	Value	95% CI
Mental Imagery Behavior: Exercise	3.52	± 0.03

Effect of the Intervention on Physical Activity Levels as Measured by Coping Planning Secondary · 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

Group	Value	95% CI
Mental Imagery Behavior: Exercise	2.98	± 0.04

Effect of the Intervention on Physical Activity Levels as Measured by Action Self-efficacy Secondary · 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

Group	Value	95% CI
Mental Imagery Behavior: Exercise	3.36	± 0.04

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Risk Ladder, Table, or Bulleted List? Identifying Formats That Effectively Communicate Personalized Risk and Risk Reduction Information for Multiple Diseases.
   Waters EA, Maki J, Liu Y, Ackermann N, et al · · 2021 · cited 14× · PMID 33106087 · DOI 10.1177/0272989x20968070
2. Mental imagery-based self-regulation: Effects on physical activity behaviour and its cognitive and affective precursors over time.
   Ackermann N, Cameron LD, Maki J, Carter CR, et al · · 2022 · cited 4× · PMID 34523193 · DOI 10.1111/bjhp.12558