Healthy VolunteersNCT03255291
Communicating Multiple Disease Risks: A Translation of Risk Prediction Science
A study testing Risk Assessment App, Audio Recording - Sleep and Surveys in people with Healthy Volunteers, run by Washington University School of Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Risk Assessment App, Audio Recording - Sleep and Surveys
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2017to 3 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
- Being tested
- Risk Assessment App, Audio Recording - Sleep, Surveys, Audio Recording - Exercise, Text message reminders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Assessment AppBehavioural
The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.
Audio Recording - SleepBehavioural
-Participants imagine themselves improving sleep hygiene
SurveysOther
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 - ExerciseBehavioural
Participants imagine themselves improving exercise
Text message remindersOther
-Reminders to practice mental imagery
Text Message SurveyOther
-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Risk Assessment App; Behavioral: Audio Recording - Sleep; Other: Surveys; Other: Text message reminders; Other: Text Message Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start27 Jun 2017
- Primary completion3 Jan 2019
- Study completion3 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Erika Waters, MPH, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255291
- Sponsor's protocol ID
- 201706063
- Other IDs
- R01CA190391
- Status last verified
- Jan 2020
- First submitted
- 7 Aug 2017
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communicating Multiple Disease Risks: A Translation of Risk Prediction Science
- ClinicalTrials.gov ID
- NCT03255291
- Acronym / sponsor ID
- 201706063
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Experimental | Behavioral: Risk Assessment App, Other: Surveys, Behavioral: Audio Recording - Exercise, Other: Text message reminders, Other: Text Message Survey* 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. |
| Risk Display Format:Risk Ladder:Imagery Behavior:Sleep | Experimental | Behavioral: Risk Assessment App, Behavioral: Audio Recording - Sleep, Other: Surveys, Other: Text message reminders, Other: Text Message Survey* 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. |
| Risk Display Format:Table:Imagery Behavior:Exercise | Experimental | Behavioral: Risk Assessment App, Other: Surveys, Behavioral: Audio Recording - Exercise, Other: Text message reminders, Other: Text Message Survey* 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. |
| Risk Display Format:Table: Imagery Behavior:Sleep | Experimental | Behavioral: Risk Assessment App, Behavioral: Audio Recording - Sleep, Other: Surveys, Other: Text message reminders, Other: Text Message Survey* 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. |
| Risk Display Format:Text:Imagery Behavior:Exercise | Experimental | Behavioral: Risk Assessment App, Other: Surveys, Behavioral: Audio Recording - Exercise, Other: Text message reminders, Other: Text Message Survey* 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. |
| Risk Display Format:Text:Imagery Behavior:Sleep | Experimental | Behavioral: Risk Assessment App, Behavioral: Audio Recording - Sleep, Other: Surveys, Other: Text message reminders, Other: Text Message Survey* 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. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk Assessment AppThe App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke. | Behavioural | 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-Participants imagine themselves improving sleep hygiene | Behavioural | Risk Display Format:Risk Ladder:Imagery Behavior:Sleep, Risk Display Format:Table: Imagery Behavior:Sleep, Risk Display Format:Text:Imagery Behavior:Sleep |
| SurveysAssesses information comprehension, intentions, perceived risk and severity worry, self- efficacy, response efficacy, affect, race, education, age, numeracy, graph literacy, and exercise and sleep behaviors. | Other | 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 - ExerciseParticipants imagine themselves improving exercise | Behavioural | 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-Reminders to practice mental imagery | Other | 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-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice. | Other | 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 |
Primary outcome
Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise
Time frame: Baseline and up to 90 days
Difference in Gist Comprehension of Risk Information by Risk Display Format
Time frame: Baseline
* 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.
Difference in Verbatim Comprehension of Risk Information by Risk Communication Strategy
Time frame: Baseline
* 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.
Difference in Self-reported Intentions to Engage in Physical Activity by Risk Display Format
Time frame: Baseline
* 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
8 secondary outcomes
Effect of the Intervention on Physical Activity Levels as Measured by Maintenance Self-efficacy
Time frame: 90 days
Effect of the Intervention on Physical Activity Levels as Measured by Recovery Self-efficacy
Time frame: 90 days
Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Enjoying Behavior
Time frame: 90 days
Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Thinking Behavior is Unpleasant
Time frame: 90 days
Effect of the Intervention on Physical Activity Levels as Measured by Perceived Vividness of Self-regulatory Imagery
Time frame: 90 days
Effect of the Intervention on Physical Activity Levels as Measured by Action Planning
Time frame: 90 days
Effect of the Intervention on Physical Activity Levels as Measured by Coping Planning
Time frame: 90 days
Effect of the Intervention on Physical Activity Levels as Measured by Action Self-efficacy
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Waters, MPH, Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk Assessment App, Audio Recording - Sleep and Surveys in people with Healthy Volunteers, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise (time frame: Baseline and up to 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.