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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA190391 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Experimental |
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| Risk Display Format:Risk Ladder:Imagery Behavior:Sleep | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk Assessment App | Behavioral | The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke. |
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| 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 |
| Baseline |
| Difference in Verbatim Comprehension of Risk Information by Risk Communication Strategy |
| Baseline |
| Difference in Self-reported Intentions to Engage in Physical Activity by Risk Display Format |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the Intervention on Physical Activity Levels as Measured by Maintenance Self-efficacy |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erika Waters, MPH, Ph.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise |
|
| FG001 | Risk Display Format:Risk Ladder:Imagery Behavior:Sleep |
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| FG002 | Risk Display Format:Table:Imagery Behavior:Exercise |
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| FG003 | Risk Display Format:Table: Imagery Behavior:Sleep |
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| FG004 | Risk Display Format:Text:Imagery Behavior:Exercise |
|
| FG005 | Risk Display Format:Text:Imagery Behavior:Sleep |
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise | Additional participants who did not complete the 90 day follow up survey or completed the survey over 8 weeks late, were inattentive responders, had text messaging errors, or were considered an outlier (>99th percentile) in change in minutes of exercise per week were excluded for analysis | Posted | Least Squares Mean | Standard Error | minutes | Baseline and up to 90 days |
|
Adverse events were not collected for this study.
Adverse events were not collected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erika Waters, MPH, Ph.D. | Washington University School of Medicine | 314-286-2757 | waterse@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2017 | Nov 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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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.
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The research staff will be blinded to participants' risk display format conditions, but they will be unblinded to mental imagery behavior condition
| Risk Display Format:Table:Imagery Behavior:Exercise | Experimental |
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| Risk Display Format:Table: Imagery Behavior:Sleep | Experimental |
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| Risk Display Format:Text:Imagery Behavior:Exercise | Experimental |
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| Risk Display Format:Text:Imagery Behavior:Sleep | Experimental |
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| Audio Recording - Sleep | Behavioral | -Participants imagine themselves improving sleep hygiene |
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| 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. |
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| Audio Recording - Exercise | Behavioral | Participants imagine themselves improving exercise |
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| Text message reminders | Other | -Reminders to practice mental imagery |
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| Text Message Survey | Other | -Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice. |
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| Baseline |
| 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 |
| Effect of the Intervention on Physical Activity Levels as Measured by Action Planning |
| 90 days |
| Effect of the Intervention on Physical Activity Levels as Measured by Coping Planning |
| 90 days |
| Effect of the Intervention on Physical Activity Levels as Measured by Action Self-efficacy |
| 90 days |
| Baseline data collection issues |
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| BG001 | Risk Display Format:Risk Ladder:Imagery Behavior:Sleep |
|
| BG002 | Risk Display Format:Table:Imagery Behavior:Exercise |
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| BG003 | Risk Display Format:Table:Imagery Behavior:Sleep |
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| BG004 | Risk Display Format:Text:Imagery Behavior:Exercise |
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| BG005 | Risk Display Format:Text:Imagery Behavior:Sleep |
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| BG006 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Vocational-technical training or less | Count of Participants | Participants |
|
| Body mass index (BMI) - Obese | -Having a BMI of 30 or greater | Count of Participants | Participants |
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| Body mass index (BMI) - Overweight | -Having a BMI of 25 - less than 30 | Count of Participants | Participants |
|
| 1+ comorbidity | -Does the participant have one more serious comorbidities (cancer, diabetes, heart disease, stroke)? | Count of Participants | Participants |
|
| Baseline Exercise (minutes per week in last 7 days) | Mean | Standard Deviation | minutes |
|
| Self-Reported Health | -Self-reported health consisted of question asking "In general, would you say that your health is." with choices of Excellent, Very good, Good, Fair, or Poor. Measured on a scale of 1-5, with 5 being higher self-reported health. | Mean | Standard Deviation | units on a scale |
|
| Numeracy |
| Mean | Standard Deviation | units on a scale |
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| Graph literacy |
| Mean | Standard Deviation | units on a scale |
|
| OG001 | Risk Display Format:Risk Ladder:Imagery Behavior:Sleep |
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| OG002 | Risk Display Format:Table:Imagery Behavior:Exercise |
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| OG003 | Risk Display Format:Table: Imagery Behavior:Sleep |
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| OG004 | Risk Display Format:Text:Imagery Behavior:Exercise |
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| OG005 | Risk Display Format:Text:Imagery Behavior:Sleep |
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| Primary | Difference in Gist Comprehension of Risk Information by Risk Display Format |
| This study was designed as a 3X2 factorial design & only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline |
|
|
|
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| Primary | Difference in Verbatim Comprehension of Risk Information by Risk Communication Strategy |
| This study was designed as a 3X2 factorial design & only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline |
|
|
|
|
| Primary | Difference in Self-reported Intentions to Engage in Physical Activity by Risk Display Format |
| This study was designed as a 3X2 factorial design & only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline |
|
|
|
|
| Secondary | Effect of the Intervention on Physical Activity Levels as Measured by Maintenance Self-efficacy |
| Due to the limitations of data collection & concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related maintenance self-efficacy among participants who engaged in the exercise-related mental imagery condition. | Posted | Mean | Standard Error | score on a scale | 90 days |
|
|
|
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| Secondary | Effect of the Intervention on Physical Activity Levels as Measured by Recovery Self-efficacy |
| Due to the limitations of data collection & concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related recovery self-efficacy among participants who engaged in the exercise-related mental imagery condition. | Posted | Mean | Standard Error | score on a scale | 90 days |
|
|
|
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| Secondary | Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Enjoying Behavior |
| Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related affective attitudes among participants who engaged in the exercise-related mental imagery condition. | Posted | Mean | Standard Error | score on a scale | 90 days |
|
|
|
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| Secondary | Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Thinking Behavior is Unpleasant |
| Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related affective attitudes among participants who engaged in the exercise-related mental imagery condition. | Posted | Mean | Standard Error | score on a scale | 90 days |
|
|
|
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| Secondary | Effect of the Intervention on Physical Activity Levels as Measured by Perceived Vividness of Self-regulatory Imagery |
| Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related perceived vividness of self-regulatory imagery among participants who engaged in the exercise-related mental imagery condition. | Posted | Mean | Standard Error | score on a scale | 90 days |
|
|
|
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| Secondary | Effect of the Intervention on Physical Activity Levels as Measured by Action Planning |
| Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related action planning among participants who engaged in the exercise-related mental imagery condition. | Posted | Mean | Standard Error | score on a scale | 90 days |
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| Secondary | Effect of the Intervention on Physical Activity Levels as Measured by Coping Planning |
| Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related coping planning among participants who engaged in the exercise-related mental imagery condition. | Posted | Mean | Standard Error | score on a scale | 90 days |
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|
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| Secondary | Effect of the Intervention on Physical Activity Levels as Measured by Action Self-efficacy |
| Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related action self-efficacy among participants who engaged in the exercise-related mental imagery condition. | Posted | Mean | Standard Error | score on a scale | 90 days |
|
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| 0 |
| 80 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Risk Display Format:Risk Ladder:Imagery Behavior:Sleep |
| 0 | 78 | 0 | 0 | 0 | 0 |
| EG002 | Risk Display Format:Table:Imagery Behavior:Exercise |
| 0 | 85 | 0 | 0 | 0 | 0 |
| EG003 | Risk Display Format:Table:Imagery Behavior:Sleep |
| 0 | 84 | 0 | 0 | 0 | 0 |
| EG004 | Risk Display Format:Text:Imagery Behavior:Exercise |
| 0 | 88 | 0 | 0 | 0 | 0 |
| EG005 | Risk Display Format:Text:Imagery Behavior:Sleep |
| 0 | 85 | 0 | 0 | 0 | 0 |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |