CClinicalTrials.gg
CompletedNCT03255291Updated Jan 18, 2020Results posted

Communicating Multiple Disease Risks: A Translation of Risk Prediction Science

An interventional study of Risk Assessment App and Audio Recording - Sleep in Healthy Volunteers, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 30 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-18.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
554
Allocation
Randomized
Ages
30 Years to 64 Years
Sex
All
01

Study summary

Epidemiology seeks to improve public health by identifying risk factors for cancer and other diseases and conveying that information to relevant audiences (e.g., physicians, the public). The audience is presumed to understand and use that information to make appropriate decisions about lifestyle behaviors and medical treatments. Yet, even though a single risk factor can affect the risk of multiple health outcomes, this information is seldom communicated to people in a way that optimizes their understanding of the importance of engaging in a single healthy behavior. Providing individuals with the ability to understand how a single behavior (obtaining sufficient physical activity) could affect their risk of developing multiple diseases could foster a more coherent and meaningful picture of the behavior's importance in reducing health risks, increase motivation and intentions to engage in the behavior, and over time improve public health.

The proposed study translates epidemiological data about five diseases that cause significant morbidity and mortality (i.e., colon cancer, breast cancer (women), heart disease, diabetes, and stroke) into a visual display that conveys individualized risk estimates in a comprehensible, meaningful, and useful way to diverse lay audiences.

02

Conditions studied

  • Healthy Volunteers
03

Who can participate

Ages eligible
30 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Investigator)
Enrollment
554 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Risk Assessment App · Other: Surveys · Behavioral: Audio Recording - Exercise · Other: Text message reminders · Other: Text Message Survey

  • Experimental
    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.

    Behavioral: Risk Assessment App · Behavioral: Audio Recording - Sleep · Other: Surveys · Other: Text message reminders · Other: Text Message Survey

  • Experimental
    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.

    Behavioral: Risk Assessment App · Other: Surveys · Behavioral: Audio Recording - Exercise · Other: Text message reminders · Other: Text Message Survey

  • Experimental
    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.

    Behavioral: Risk Assessment App · Behavioral: Audio Recording - Sleep · Other: Surveys · Other: Text message reminders · Other: Text Message Survey

  • Experimental
    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.

    Behavioral: Risk Assessment App · Other: Surveys · Behavioral: Audio Recording - Exercise · Other: Text message reminders · Other: Text Message Survey

  • Experimental
    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.

    Behavioral: Risk Assessment App · Behavioral: Audio Recording - Sleep · Other: Surveys · Other: Text message reminders · Other: Text Message Survey

Interventions

  • BehavioralRisk Assessment App

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

  • BehavioralAudio Recording - Sleep

    -Participants imagine themselves improving sleep hygiene

  • OtherSurveys

    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.

  • BehavioralAudio Recording - Exercise

    Participants imagine themselves improving exercise

  • OtherText message reminders

    -Reminders to practice mental imagery

  • OtherText Message Survey

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

05

What researchers measure

Primary outcomes

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

    Time frame: Baseline and up to 90 days

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. 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

    Time frame: Baseline

Secondary outcomes

  1. 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

    Time frame: 90 days

  2. 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

    Time frame: 90 days

  3. 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

    Time frame: 90 days

  4. 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

    Time frame: 90 days

  5. 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

    Time frame: 90 days

  6. 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

    Time frame: 90 days

  7. 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

    Time frame: 90 days

  8. 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

    Time frame: 90 days

06

Results

Posted Jan 18, 2020

Participant flow

Participant flow — Overall Study
MilestoneRisk Display Format:Risk Ladder:Imagery Behavior:ExerciseRisk Display Format:Risk Ladder:Imagery Behavior:SleepRisk Display Format:Table:Imagery Behavior:ExerciseRisk Display Format:Table: Imagery Behavior:SleepRisk Display Format:Text:Imagery Behavior:ExerciseRisk Display Format:Text:Imagery Behavior:Sleep
Started939091909595
Completed807885848885
Not completed131266710
Withdrew: Determined to be ineligible101266510
Withdrew: Baseline data collection issues300020

Outcome measures

PrimaryChange From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise
Time frame:
Baseline and up to 90 days
Reported as:
Least squares mean · minutes
Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise
minutesRisk Display Format:Risk Ladder:Imagery Behavior:ExerciseRisk Display Format:Risk Ladder:Imagery Behavior:SleepRisk Display Format:Table:Imagery Behavior:ExerciseRisk Display Format:Table: Imagery Behavior:SleepRisk Display Format:Text:Imagery Behavior:ExerciseRisk Display Format:Text:Imagery Behavior:Sleep
Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise92.2 ± 12.737.5 ± 13.463.1 ± 12.460.0 ± 12.950.1 ± 12.549.3 ± 13.0
Statistical analysis
  • Risk Display Format:Risk Ladder:Imagery Behavior:Sleep vs Risk Display Format:Table: Imagery Behavior:Sleep vs Risk Display Format:Text:Imagery Behavior:Sleep · ANCOVA · p = 0.0288Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.
  • Risk Display Format:Text:Imagery Behavior:Exercise vs Risk Display Format:Text:Imagery Behavior:Sleep · ANCOVA · p = 0.3329Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.
  • Risk Display Format:Text:Imagery Behavior:Sleep · ANCOVA · p = 0.0215Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.
PrimaryDifference 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.

Time frame:
Baseline
Reported as:
Least squares mean · score on a scale
Difference in Gist Comprehension of Risk Information by Risk Display Format
score on a scaleRisk Display Format: Risk LadderRisk Display Format: TableRisk Display Format: Text
Difference in Gist Comprehension of Risk Information by Risk Display Format3.6 ± 0.13.4 ± 0.13.2 ± 0.1
Statistical analysis
  • Risk Display Format: Risk Ladder vs Risk Display Format: Table vs Risk Display Format: Text · ANCOVA · p = 0.0333 (-A Dunnett adjustment was used to adjust for multiple comparisons)Covariates were sex, race, age, education, numeracy, and graph literacy.
PrimaryDifference 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.

Time frame:
Baseline
Reported as:
Least squares mean · score on a scale
Difference in Verbatim Comprehension of Risk Information by Risk Communication Strategy
score on a scaleRisk Display Format: Risk LadderRisk Display Format: TableRisk Display Format: Text
Difference in Verbatim Comprehension of Risk Information by Risk Communication Strategy1.6 ± 0.11.6 ± 0.11.5 ± 0.1
Statistical analysis
  • Risk Display Format: Risk Ladder vs Risk Display Format: Table vs Risk Display Format: Text · ANCOVA · p = 0.4946 (-A Dunnett adjustment was used to adjust for multiple comparisons)Covariates were sex, race, age, education, numeracy, and graph literacy.
PrimaryDifference 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

Time frame:
Baseline
Reported as:
Least squares mean · score on a scale
Difference in Self-reported Intentions to Engage in Physical Activity by Risk Display Format
score on a scaleRisk Display Format: Risk LadderRisk Display Format: TableRisk Display Format: Text
Difference in Self-reported Intentions to Engage in Physical Activity by Risk Display Format3.9 ± 0.14.0 ± 0.13.8 ± 0.1
Statistical analysis
  • Risk Display Format: Risk Ladder vs Risk Display Format: Table vs Risk Display Format: Text · ANCOVA · p = 0.1397Covariates were sex, race, age, education, numeracy, and graph literacy.
SecondaryEffect 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

Time frame:
90 days
Reported as:
Mean · score on a scale
Effect of the Intervention on Physical Activity Levels as Measured by Maintenance Self-efficacy
score on a scaleMental Imagery Behavior: Exercise
Effect of the Intervention on Physical Activity Levels as Measured by Maintenance Self-efficacy2.95 ± 0.05
Statistical analysis
  • Mental Imagery Behavior: Exercise · Mixed Models Analysis · p = 0.0070 (Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise)
SecondaryEffect 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

Time frame:
90 days
Reported as:
Mean · score on a scale
Effect of the Intervention on Physical Activity Levels as Measured by Recovery Self-efficacy
score on a scaleMental Imagery Behavior: Exercise
Effect of the Intervention on Physical Activity Levels as Measured by Recovery Self-efficacy3.26 ± 0.05
Statistical analysis
  • Mental Imagery Behavior: Exercise · Mixed Models Analysis · p = 0.8793 (Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise)
SecondaryEffect 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

Time frame:
90 days
Reported as:
Mean · score on a scale
Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Enjoying Behavior
score on a scaleMental Imagery Behavior: Exercise
Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Enjoying Behavior3.05 ± 0.05
Statistical analysis
  • Mental Imagery Behavior: Exercise · Mixed Models Analysis · p = 0.4673 (Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise)
SecondaryEffect 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

Time frame:
90 days
Reported as:
Mean · score on a scale
Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Thinking Behavior is Unpleasant
score on a scaleMental Imagery Behavior: Exercise
Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Thinking Behavior is Unpleasant3.19 ± 0.05
Statistical analysis
  • Mental Imagery Behavior: Exercise · Mixed Models Analysis · p = 0.1916 (Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise)
SecondaryEffect 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

Time frame:
90 days
Reported as:
Mean · score on a scale
Effect of the Intervention on Physical Activity Levels as Measured by Perceived Vividness of Self-regulatory Imagery
score on a scaleMental Imagery Behavior: Exercise
Effect of the Intervention on Physical Activity Levels as Measured by Perceived Vividness of Self-regulatory Imagery3.36 ± 0.04
Statistical analysis
  • Mental Imagery Behavior: Exercise · Mixed Models Analysis · p = 0.8661 (Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise)
SecondaryEffect 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

Time frame:
90 days
Reported as:
Mean · score on a scale
Effect of the Intervention on Physical Activity Levels as Measured by Action Planning
score on a scaleMental Imagery Behavior: Exercise
Effect of the Intervention on Physical Activity Levels as Measured by Action Planning3.52 ± 0.03
Statistical analysis
  • Mental Imagery Behavior: Exercise · Mixed Models Analysis · p = 0.0711 (Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise)
SecondaryEffect 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

Time frame:
90 days
Reported as:
Mean · score on a scale
Effect of the Intervention on Physical Activity Levels as Measured by Coping Planning
score on a scaleMental Imagery Behavior: Exercise
Effect of the Intervention on Physical Activity Levels as Measured by Coping Planning2.98 ± 0.04
Statistical analysis
  • Mental Imagery Behavior: Exercise · Mixed Models Analysis · p = 0.0365 (Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise)
SecondaryEffect 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

Time frame:
90 days
Reported as:
Mean · score on a scale
Effect of the Intervention on Physical Activity Levels as Measured by Action Self-efficacy
score on a scaleMental Imagery Behavior: Exercise
Effect of the Intervention on Physical Activity Levels as Measured by Action Self-efficacy3.36 ± 0.04
Statistical analysis
  • Mental Imagery Behavior: Exercise · Mixed Models Analysis · p = 0.1511 (Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise)

Adverse events

Collected over Adverse events were not collected for this study.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Risk Display Format:Risk Ladder:Imagery Behavior:Exercise0/80 (0%)——
Risk Display Format:Risk Ladder:Imagery Behavior:Sleep0/78 (0%)——
Risk Display Format:Table:Imagery Behavior:Exercise0/85 (0%)——
Risk Display Format:Table:Imagery Behavior:Sleep0/84 (0%)——
Risk Display Format:Text:Imagery Behavior:Exercise0/88 (0%)——
Risk Display Format:Text:Imagery Behavior:Sleep0/85 (0%)——

Baseline characteristics

Age, Continuous
Age, Continuous(years)Risk Display Format:Risk Ladder:Imagery Behavior:ExerciseRisk Display Format:Risk Ladder:Imagery Behavior:SleepRisk Display Format:Table:Imagery Behavior:ExerciseRisk Display Format:Table:Imagery Behavior:SleepRisk Display Format:Text:Imagery Behavior:ExerciseRisk Display Format:Text:Imagery Behavior:SleepTotal
Mean47.2 ± 9.847.3 ± 8.750.3 ± 9.949.8 ± 9.946.8 ± 10.747.2 ± 10.548.1 ± 10.0
Sex: Female, Male
Sex: Female, Male(Participants)Risk Display Format:Risk Ladder:Imagery Behavior:ExerciseRisk Display Format:Risk Ladder:Imagery Behavior:SleepRisk Display Format:Table:Imagery Behavior:ExerciseRisk Display Format:Table:Imagery Behavior:SleepRisk Display Format:Text:Imagery Behavior:ExerciseRisk Display Format:Text:Imagery Behavior:SleepTotal
Female636768676973407
Male17111717191293
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Risk Display Format:Risk Ladder:Imagery Behavior:ExerciseRisk Display Format:Risk Ladder:Imagery Behavior:SleepRisk Display Format:Table:Imagery Behavior:ExerciseRisk Display Format:Table:Imagery Behavior:SleepRisk Display Format:Text:Imagery Behavior:ExerciseRisk Display Format:Text:Imagery Behavior:SleepTotal
Hispanic or Latino41154217
Not Hispanic or Latino767784798483483
Unknown or Not Reported0000000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Risk Display Format:Risk Ladder:Imagery Behavior:ExerciseRisk Display Format:Risk Ladder:Imagery Behavior:SleepRisk Display Format:Table:Imagery Behavior:ExerciseRisk Display Format:Table:Imagery Behavior:SleepRisk Display Format:Text:Imagery Behavior:ExerciseRisk Display Format:Text:Imagery Behavior:SleepTotal
American Indian/Alaskan Native1010002
Asian/Pacific Islander1020126
Black/African American273526373723185
White/Caucasian494350404656284
Multiracial/Other20674423
Region of Enrollment
Region of Enrollment(participants)Risk Display Format:Risk Ladder:Imagery Behavior:ExerciseRisk Display Format:Risk Ladder:Imagery Behavior:SleepRisk Display Format:Table:Imagery Behavior:ExerciseRisk Display Format:Table:Imagery Behavior:SleepRisk Display Format:Text:Imagery Behavior:ExerciseRisk Display Format:Text:Imagery Behavior:SleepTotal
United States807885848885500
Vocational-technical training or less
Vocational-technical training or less(Participants)Risk Display Format:Risk Ladder:Imagery Behavior:ExerciseRisk Display Format:Risk Ladder:Imagery Behavior:SleepRisk Display Format:Table:Imagery Behavior:ExerciseRisk Display Format:Table:Imagery Behavior:SleepRisk Display Format:Text:Imagery Behavior:ExerciseRisk Display Format:Text:Imagery Behavior:SleepTotal
Count of participants20201414151497
Body mass index (BMI) - Obese
Body mass index (BMI) - Obese(Participants)Risk Display Format:Risk Ladder:Imagery Behavior:ExerciseRisk Display Format:Risk Ladder:Imagery Behavior:SleepRisk Display Format:Table:Imagery Behavior:ExerciseRisk Display Format:Table:Imagery Behavior:SleepRisk Display Format:Text:Imagery Behavior:ExerciseRisk Display Format:Text:Imagery Behavior:SleepTotal
Count of participants383246524842258
Body mass index (BMI) - Overweight
Body mass index (BMI) - Overweight(Participants)Risk Display Format:Risk Ladder:Imagery Behavior:ExerciseRisk Display Format:Risk Ladder:Imagery Behavior:SleepRisk Display Format:Table:Imagery Behavior:ExerciseRisk Display Format:Table:Imagery Behavior:SleepRisk Display Format:Text:Imagery Behavior:ExerciseRisk Display Format:Text:Imagery Behavior:SleepTotal
Count of participants212319152425127

5 further baseline measures are reported on the registry.

07

Study locations

1 site
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · May 4, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03255291
Lead sponsor
Washington University School of Medicine
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 21, 2017
Start date
Jun 27, 2017
Primary completion
Jan 3, 2019
Completion
Jan 3, 2019
Results posted
Jan 18, 2020
Last update
Jan 18, 2020

Study contacts

Erika Waters, MPH, Ph.D.
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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