Communicating Multiple Disease Risks: A Translation of Risk Prediction Science

Healthy Volunteers Clinical Trial

Official title:

Communicating Multiple Disease Risks: A Translation of Risk Prediction Science

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03255291
• Other study ID #: 201706063
• Secondary ID: R01CA190391
• Status: Completed
• Phase: N/A
• Start date: June 27, 2017
• Est. completion date: January 3, 2019

Study information

• Verified date: January 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: January 3, 2019
• Est. primary completion date: January 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Behavioral:
• Risk Assessment App
The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.
• Audio Recording - Sleep
-Participants imagine themselves improving sleep hygiene

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise		Baseline and up to 90 days
Primary	Difference in Gist Comprehension of Risk Information by Risk Display Format	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
Primary	Difference in Verbatim Comprehension of Risk Information by Risk Communication Strategy	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
Primary	Difference in Self-reported Intentions to Engage in Physical Activity by Risk Display Format	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	Effect of the Intervention on Physical Activity Levels as Measured by Maintenance Self-efficacy	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
Secondary	Effect of the Intervention on Physical Activity Levels as Measured by Recovery Self-efficacy	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
Secondary	Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Enjoying Behavior	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
Secondary	Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Thinking Behavior is Unpleasant	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
Secondary	Effect of the Intervention on Physical Activity Levels as Measured by Perceived Vividness of Self-regulatory Imagery	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
Secondary	Effect of the Intervention on Physical Activity Levels as Measured by Action Planning	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
Secondary	Effect of the Intervention on Physical Activity Levels as Measured by Coping Planning	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
Secondary	Effect of the Intervention on Physical Activity Levels as Measured by Action Self-efficacy	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

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine