Clinical trial NCT03255291: Communicating Multiple Disease Risks: A Translation of Risk Prediction Science
Official title: Communicating Multiple Disease Risks: A Translation of Risk Prediction Science
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2017-08-21
Enrollment: 554
Sex: ALL
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants were randomly assigned by a computer algorithm to one of six intervention arms according to a 3 (risk display format: text, table, ladder) x 2 (imagery behavior: exercise, sleep) between-subjects factorial design. Although randomization was done at the same time and at the beginning of the study, participants received the risk display intervention first, then answered a survey containing two of the primary outcomes, then received the mental imagery intervention followed by another survey.
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise
timeFrame: Baseline and up to 90 days
measure: Difference in Gist Comprehension of Risk Information by Risk Display Format
timeFrame: Baseline
measure: Difference in Verbatim Comprehension of Risk Information by Risk Communication Strategy
timeFrame: Baseline
measure: Difference in Self-reported Intentions to Engage in Physical Activity by Risk Display Format
timeFrame: Baseline
Secondary outcomes:
measure: Effect of the Intervention on Physical Activity Levels as Measured by Maintenance Self-efficacy
timeFrame: 90 days
measure: Effect of the Intervention on Physical Activity Levels as Measured by Recovery Self-efficacy
timeFrame: 90 days
measure: Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Enjoying Behavior
timeFrame: 90 days
measure: Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Thinking Behavior is Unpleasant
timeFrame: 90 days
measure: Effect of the Intervention on Physical Activity Levels as Measured by Perceived Vividness of Self-regulatory Imagery
timeFrame: 90 days
measure: Effect of the Intervention on Physical Activity Levels as Measured by Action Planning
timeFrame: 90 days
measure: Effect of the Intervention on Physical Activity Levels as Measured by Coping Planning
timeFrame: 90 days
measure: Effect of the Intervention on Physical Activity Levels as Measured by Action Self-efficacy
timeFrame: 90 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Erika Waters, MPH, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: