Communicating Multiple Disease Risks: A Translation of Risk Prediction Science

NCT ID: NCT03255291

Last Updated: 2020-01-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

554 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-27

Study Completion Date

2019-01-03

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
The research staff will be blinded to participants' risk display format conditions, but they will be unblinded to mental imagery behavior condition

Study Groups

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Risk Display Format:Risk Ladder:Imagery Behavior:Exercise

* 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.

Group Type EXPERIMENTAL

Risk Assessment App

Intervention Type BEHAVIORAL

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

Surveys

Intervention Type 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

Intervention Type BEHAVIORAL

Participants imagine themselves improving exercise

Text message reminders

Intervention Type OTHER

-Reminders to practice mental imagery

Text Message Survey

Intervention Type OTHER

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

Risk Display Format:Risk Ladder:Imagery Behavior:Sleep

* 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.

Group Type EXPERIMENTAL

Risk Assessment App

Intervention Type BEHAVIORAL

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

Audio Recording - Sleep

Intervention Type BEHAVIORAL

-Participants imagine themselves improving sleep hygiene

Surveys

Intervention Type 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.

Text message reminders

Intervention Type OTHER

-Reminders to practice mental imagery

Text Message Survey

Intervention Type OTHER

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

Risk Display Format:Table:Imagery Behavior:Exercise

* 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.

Group Type EXPERIMENTAL

Risk Assessment App

Intervention Type BEHAVIORAL

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

Surveys

Intervention Type 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

Intervention Type BEHAVIORAL

Participants imagine themselves improving exercise

Text message reminders

Intervention Type OTHER

-Reminders to practice mental imagery

Text Message Survey

Intervention Type OTHER

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

Risk Display Format:Table: Imagery Behavior:Sleep

* 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.

Group Type EXPERIMENTAL

Risk Assessment App

Intervention Type BEHAVIORAL

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

Audio Recording - Sleep

Intervention Type BEHAVIORAL

-Participants imagine themselves improving sleep hygiene

Surveys

Intervention Type 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.

Text message reminders

Intervention Type OTHER

-Reminders to practice mental imagery

Text Message Survey

Intervention Type OTHER

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

Risk Display Format:Text:Imagery Behavior:Exercise

* 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.

Group Type EXPERIMENTAL

Risk Assessment App

Intervention Type BEHAVIORAL

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

Surveys

Intervention Type 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

Intervention Type BEHAVIORAL

Participants imagine themselves improving exercise

Text message reminders

Intervention Type OTHER

-Reminders to practice mental imagery

Text Message Survey

Intervention Type OTHER

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

Risk Display Format:Text:Imagery Behavior:Sleep

* 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.

Group Type EXPERIMENTAL

Risk Assessment App

Intervention Type BEHAVIORAL

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

Audio Recording - Sleep

Intervention Type BEHAVIORAL

-Participants imagine themselves improving sleep hygiene

Surveys

Intervention Type 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.

Text message reminders

Intervention Type OTHER

-Reminders to practice mental imagery

Text Message Survey

Intervention Type OTHER

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

Interventions

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Risk Assessment App

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

Intervention Type BEHAVIORAL

Audio Recording - Sleep

-Participants imagine themselves improving sleep hygiene

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Audio Recording - Exercise

Participants imagine themselves improving exercise

Intervention Type BEHAVIORAL

Text message reminders

-Reminders to practice mental imagery

Intervention Type OTHER

Text Message Survey

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erika Waters, MPH, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.siteman.wustl.edu

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

Other Identifiers

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R01CA190391

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201706063

Identifier Type: -

Identifier Source: org_study_id

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