Communicating Multiple Disease Risks: A Translation of Risk Prediction Science

NCT03255291 | Completed Results

• 2 other identifiers: 201706063R01CA190391
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

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

  Baseline and up to 90 days

• 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

• 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

• 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 Outcomes (8)

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

  90 days

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

  90 days

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

  90 days

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

  90 days

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

  90 days

Study Arms (6)

Risk Display Format:Risk Ladder:Imagery Behavior:Exercise

EXPERIMENTAL

* 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; Other: Surveys; Behavioral: Audio Recording - Exercise; Other: Text message reminders; Other: Text Message Survey

Risk Display Format:Risk Ladder:Imagery Behavior:Sleep

EXPERIMENTAL

* 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; Behavioral: Audio Recording - Sleep; Other: Surveys; Other: Text message reminders; Other: Text Message Survey

Risk Display Format:Table:Imagery Behavior:Exercise

EXPERIMENTAL

* 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; Other: Surveys; Behavioral: Audio Recording - Exercise; Other: Text message reminders; Other: Text Message Survey

Risk Display Format:Table: Imagery Behavior:Sleep

EXPERIMENTAL

* 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; Behavioral: Audio Recording - Sleep; Other: Surveys; Other: Text message reminders; Other: Text Message Survey

Risk Display Format:Text:Imagery Behavior:Exercise

EXPERIMENTAL

* 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; Other: Surveys; Behavioral: Audio Recording - Exercise; Other: Text message reminders; Other: Text Message Survey

Risk Display Format:Text:Imagery Behavior:Sleep

EXPERIMENTAL

* 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; Behavioral: Audio Recording - Sleep; Other: Surveys; Other: Text message reminders; Other: Text Message Survey

Interventions

Risk Assessment App BEHAVIORAL

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

Risk Display Format:Risk Ladder:Imagery Behavior:Exercise; Risk Display Format:Risk Ladder:Imagery Behavior:Sleep; Risk Display Format:Table: Imagery Behavior:Sleep; Risk Display Format:Table:Imagery Behavior:Exercise; Risk Display Format:Text:Imagery Behavior:Exercise; Risk Display Format:Text:Imagery Behavior:Sleep

Audio Recording - Sleep BEHAVIORAL

-Participants imagine themselves improving sleep hygiene

Risk Display Format:Risk Ladder:Imagery Behavior:Sleep; Risk Display Format:Table: Imagery Behavior:Sleep; Risk Display Format:Text:Imagery Behavior:Sleep

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.

Risk Display Format:Risk Ladder:Imagery Behavior:Exercise; Risk Display Format:Risk Ladder:Imagery Behavior:Sleep; Risk Display Format:Table: Imagery Behavior:Sleep; Risk Display Format:Table:Imagery Behavior:Exercise; Risk Display Format:Text:Imagery Behavior:Exercise; Risk Display Format:Text:Imagery Behavior:Sleep

Audio Recording - Exercise BEHAVIORAL

Participants imagine themselves improving exercise

Risk Display Format:Risk Ladder:Imagery Behavior:Exercise; Risk Display Format:Table:Imagery Behavior:Exercise; Risk Display Format:Text:Imagery Behavior:Exercise

Text message reminders OTHER

-Reminders to practice mental imagery

Risk Display Format:Risk Ladder:Imagery Behavior:Exercise; Risk Display Format:Risk Ladder:Imagery Behavior:Sleep; Risk Display Format:Table: Imagery Behavior:Sleep; Risk Display Format:Table:Imagery Behavior:Exercise; Risk Display Format:Text:Imagery Behavior:Exercise; Risk Display Format:Text:Imagery Behavior:Sleep

Text Message Survey OTHER

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

Risk Display Format:Risk Ladder:Imagery Behavior:Exercise; Risk Display Format:Risk Ladder:Imagery Behavior:Sleep; Risk Display Format:Table: Imagery Behavior:Sleep; Risk Display Format:Table:Imagery Behavior:Exercise; Risk Display Format:Text:Imagery Behavior:Exercise; Risk Display Format:Text:Imagery Behavior:Sleep

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Erika Waters, MPH, Ph.D.
• Organization: Washington University School of Medicine

waterse@wustl.edu

314-286-2757

Study Officials

• Erika Waters, MPH, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The research staff will be blinded to participants' risk display format conditions, but they will be unblinded to mental imagery behavior condition
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 21, 2017
• Study Start: June 27, 2017
• Primary Completion: January 3, 2019
• Study Completion: January 3, 2019
• Last Updated: January 18, 2020
• Results First Posted: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)