Communicating Multiple Disease Risks: A Translation of Risk Prediction Science

Study Overview
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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.

Official Title
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Communicating Multiple Disease Risks: A Translation of Risk Prediction Science

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Behavioral: Risk Assessment App
* Behavioral: Audio Recording - Sleep
* Other: Surveys
* Behavioral: Audio Recording - Exercise
* Other: Text message reminders
* Other: Text Message Survey


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Risk Display Format:Risk Ladder:Imagery Behavior:Exercise<br>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<br>* The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.<br>Other: Surveys<br>* 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.<br>Behavioral: Audio Recording - Exercise<br>* Participants imagine themselves improving exercise<br>Other: Text message reminders<br>* -Reminders to practice mental imagery<br>Other: Text Message Survey<br>* -Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.<br>|
| Experimental: Risk Display Format:Risk Ladder:Imagery Behavior:Sleep<br>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<br>* The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.<br>Behavioral: Audio Recording - Sleep<br>* -Participants imagine themselves improving sleep hygiene<br>Other: Surveys<br>* 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.<br>Other: Text message reminders<br>* -Reminders to practice mental imagery<br>Other: Text Message Survey<br>* -Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.<br>|
| Experimental: Risk Display Format:Table:Imagery Behavior:Exercise<br>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<br>* The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.<br>Other: Surveys<br>* 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.<br>Behavioral: Audio Recording - Exercise<br>* Participants imagine themselves improving exercise<br>Other: Text message reminders<br>* -Reminders to practice mental imagery<br>Other: Text Message Survey<br>* -Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.<br>|
| Experimental: Risk Display Format:Table: Imagery Behavior:Sleep<br>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<br>* The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.<br>Behavioral: Audio Recording - Sleep<br>* -Participants imagine themselves improving sleep hygiene<br>Other: Surveys<br>* 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.<br>Other: Text message reminders<br>* -Reminders to practice mental imagery<br>Other: Text Message Survey<br>* -Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.<br>|
| Experimental: Risk Display Format:Text:Imagery Behavior:Exercise<br>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<br>* The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.<br>Other: Surveys<br>* 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.<br>Behavioral: Audio Recording - Exercise<br>* Participants imagine themselves improving exercise<br>Other: Text message reminders<br>* -Reminders to practice mental imagery<br>Other: Text Message Survey<br>* -Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.<br>|
| Experimental: Risk Display Format:Text:Imagery Behavior:Sleep<br>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<br>* The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.<br>Behavioral: Audio Recording - Sleep<br>* -Participants imagine themselves improving sleep hygiene<br>Other: Surveys<br>* 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.<br>Other: Text message reminders<br>* -Reminders to practice mental imagery<br>Other: Text Message Survey<br>* -Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |