Healthy Volunteers
Conditions
Brief 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.
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
-Reminders to practice mental imagery
OTHERText Message Survey
-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
The research staff will be blinded to participants' risk display format conditions, but they will be unblinded to mental imagery behavior condition
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 64 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | * 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of the Intervention on Physical Activity Levels as Measured by Perceived Vividness of Self-regulatory Imagery | 90 days | * 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 |
| Effect of the Intervention on Physical Activity Levels as Measured by Action Planning | 90 days | * 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 |
| Effect of the Intervention on Physical Activity Levels as Measured by Maintenance Self-efficacy | 90 days | * 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 |
| Effect of the Intervention on Physical Activity Levels as Measured by Action Self-efficacy | 90 days | * 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 |
| Effect of the Intervention on Physical Activity Levels as Measured by Coping Planning | 90 days | * 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 |
| Effect of the Intervention on Physical Activity Levels as Measured by Recovery Self-efficacy | 90 days | * 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 |
| Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Enjoying Behavior | 90 days | * 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 |
| Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Thinking Behavior is Unpleasant | 90 days | * 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 80 |
| 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. | 78 |
| 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. | 85 |
| 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. | 84 |
| 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. | 88 |
| 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. | 85 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Baseline data collection issues | 3 | 0 | 0 | 0 | 2 | 0 |
| Overall Study | Determined to be ineligible | 10 | 12 | 6 | 6 | 5 | 10 |
Baseline characteristics
| Characteristic | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Total | Risk Display Format:Text:Imagery Behavior:Sleep | Risk Display Format:Text:Imagery Behavior:Exercise | Risk Display Format:Table:Imagery Behavior:Sleep | Risk Display Format:Table:Imagery Behavior:Exercise | Risk Display Format:Risk Ladder:Imagery Behavior:Sleep |
|---|---|---|---|---|---|---|---|
| 1+ comorbidity | 14 Participants | 92 Participants | 15 Participants | 19 Participants | 17 Participants | 21 Participants | 6 Participants |
| Age, Continuous | 47.2 years STANDARD_DEVIATION 9.8 | 48.1 years STANDARD_DEVIATION 10 | 47.2 years STANDARD_DEVIATION 10.5 | 46.8 years STANDARD_DEVIATION 10.7 | 49.8 years STANDARD_DEVIATION 9.9 | 50.3 years STANDARD_DEVIATION 9.9 | 47.3 years STANDARD_DEVIATION 8.7 |
| Baseline Exercise (minutes per week in last 7 days) | 56.7 minutes STANDARD_DEVIATION 44.8 | 52.3 minutes STANDARD_DEVIATION 44.7 | 56.0 minutes STANDARD_DEVIATION 43.4 | 41.3 minutes STANDARD_DEVIATION 41.1 | 50.2 minutes STANDARD_DEVIATION 45.4 | 53.9 minutes STANDARD_DEVIATION 47.4 | 56.9 minutes STANDARD_DEVIATION 45.1 |
| Body mass index (BMI) - Obese | 38 Participants | 258 Participants | 42 Participants | 48 Participants | 52 Participants | 46 Participants | 32 Participants |
| Body mass index (BMI) - Overweight | 21 Participants | 127 Participants | 25 Participants | 24 Participants | 15 Participants | 19 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 17 Participants | 2 Participants | 4 Participants | 5 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants | 483 Participants | 83 Participants | 84 Participants | 79 Participants | 84 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Graph literacy | 2.5 units on a scale STANDARD_DEVIATION 1.1 | 2.3 units on a scale STANDARD_DEVIATION 1.1 | 2.6 units on a scale STANDARD_DEVIATION 1 | 2.2 units on a scale STANDARD_DEVIATION 1.2 | 2.3 units on a scale STANDARD_DEVIATION 1.1 | 2.2 units on a scale STANDARD_DEVIATION 1.2 | 2.1 units on a scale STANDARD_DEVIATION 1.2 |
| Numeracy | 1.6 units on a scale STANDARD_DEVIATION 1 | 1.5 units on a scale STANDARD_DEVIATION 1 | 1.6 units on a scale STANDARD_DEVIATION 1 | 1.5 units on a scale STANDARD_DEVIATION 1.1 | 1.5 units on a scale STANDARD_DEVIATION 1.1 | 1.7 units on a scale STANDARD_DEVIATION 1 | 1.3 units on a scale STANDARD_DEVIATION 0.9 |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 1 Participants | 6 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Black/African American | 27 Participants | 185 Participants | 23 Participants | 37 Participants | 37 Participants | 26 Participants | 35 Participants |
| Race/Ethnicity, Customized Multiracial/Other | 2 Participants | 23 Participants | 4 Participants | 4 Participants | 7 Participants | 6 Participants | 0 Participants |
| Race/Ethnicity, Customized White/Caucasian | 49 Participants | 284 Participants | 56 Participants | 46 Participants | 40 Participants | 50 Participants | 43 Participants |
| Region of Enrollment United States | 80 participants | 500 participants | 85 participants | 88 participants | 84 participants | 85 participants | 78 participants |
| Self-Reported Health | 3.0 units on a scale STANDARD_DEVIATION 1 | 3.0 units on a scale STANDARD_DEVIATION 0.9 | 3.0 units on a scale STANDARD_DEVIATION 0.9 | 3.0 units on a scale STANDARD_DEVIATION 0.9 | 3.1 units on a scale STANDARD_DEVIATION 0.9 | 3.0 units on a scale STANDARD_DEVIATION 1 | 3.1 units on a scale STANDARD_DEVIATION 0.9 |
| Sex: Female, Male Female | 63 Participants | 407 Participants | 73 Participants | 69 Participants | 67 Participants | 68 Participants | 67 Participants |
| Sex: Female, Male Male | 17 Participants | 93 Participants | 12 Participants | 19 Participants | 17 Participants | 17 Participants | 11 Participants |
| Vocational-technical training or less | 20 Participants | 97 Participants | 14 Participants | 15 Participants | 14 Participants | 14 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 78 | 0 / 85 | 0 / 84 | 0 / 88 | 0 / 85 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise
Time frame: Baseline and up to 90 days
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise | 92.2 minutes | Standard Error 12.7 |
| Risk Display Format:Risk Ladder:Imagery Behavior:Sleep | Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise | 37.5 minutes | Standard Error 13.4 |
| Risk Display Format:Table:Imagery Behavior:Exercise | Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise | 63.1 minutes | Standard Error 12.4 |
| Risk Display Format:Table: Imagery Behavior:Sleep | Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise | 60.0 minutes | Standard Error 12.9 |
| Risk Display Format:Text:Imagery Behavior:Exercise | Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise | 50.1 minutes | Standard Error 12.5 |
| Risk Display Format:Text:Imagery Behavior:Sleep | Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise | 49.3 minutes | Standard Error 13 |
Comparison: The investigators tested whether weekly minutes of exercise at 90 day follow-up was higher in the exercise mental imagery condition than in the sleep mental imagery conditionp-value: 0.0288ANCOVA
Comparison: -The investigators tested whether weekly minutes of exercise differed among the three risk display formats: risk ladder, table, and alphanumeric text.p-value: 0.3329ANCOVA
Comparison: -The investigators tested whether weekly minutes of exercise was influenced by an interaction between risk display format and mental imagery behaviorp-value: 0.0215ANCOVA
Primary
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
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Difference in Gist Comprehension of Risk Information by Risk Display Format | 3.6 score on a scale | Standard Error 0.1 |
| Risk Display Format:Risk Ladder:Imagery Behavior:Sleep | Difference in Gist Comprehension of Risk Information by Risk Display Format | 3.4 score on a scale | Standard Error 0.1 |
| Risk Display Format:Table:Imagery Behavior:Exercise | Difference in Gist Comprehension of Risk Information by Risk Display Format | 3.2 score on a scale | Standard Error 0.1 |
Comparison: -This study was designed as a 3X2 factorial design and 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. A Dunnett adjustment was used to adjust for multiple comparisons.p-value: 0.0333ANCOVA
Primary
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
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Difference in Self-reported Intentions to Engage in Physical Activity by Risk Display Format | 3.9 score on a scale | Standard Error 0.1 |
| Risk Display Format:Risk Ladder:Imagery Behavior:Sleep | Difference in Self-reported Intentions to Engage in Physical Activity by Risk Display Format | 4.0 score on a scale | Standard Error 0.1 |
| Risk Display Format:Table:Imagery Behavior:Exercise | Difference in Self-reported Intentions to Engage in Physical Activity by Risk Display Format | 3.8 score on a scale | Standard Error 0.1 |
Comparison: 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.p-value: 0.1397ANCOVA
Primary
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
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Difference in Verbatim Comprehension of Risk Information by Risk Communication Strategy | 1.6 score on a scale | Standard Error 0.1 |
| Risk Display Format:Risk Ladder:Imagery Behavior:Sleep | Difference in Verbatim Comprehension of Risk Information by Risk Communication Strategy | 1.6 score on a scale | Standard Error 0.1 |
| Risk Display Format:Table:Imagery Behavior:Exercise | Difference in Verbatim Comprehension of Risk Information by Risk Communication Strategy | 1.5 score on a scale | Standard Error 0.1 |
Comparison: 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.p-value: 0.4946ANCOVA
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Effect of the Intervention on Physical Activity Levels as Measured by Action Planning | 3.52 score on a scale | Standard Error 0.03 |
Comparison: The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise action planning). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.p-value: 0.0711Mixed Models Analysis
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Effect of the Intervention on Physical Activity Levels as Measured by Action Self-efficacy | 3.36 score on a scale | Standard Error 0.04 |
Comparison: The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise action self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.p-value: 0.1511Mixed Models Analysis
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Enjoying Behavior | 3.05 score on a scale | Standard Error 0.05 |
Comparison: The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise affective attitudes). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.p-value: 0.4673Mixed Models Analysis
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Thinking Behavior is Unpleasant | 3.19 score on a scale | Standard Error 0.05 |
Comparison: The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise unpleasant feelings). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.p-value: 0.1916Mixed Models Analysis
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Effect of the Intervention on Physical Activity Levels as Measured by Coping Planning | 2.98 score on a scale | Standard Error 0.04 |
Comparison: The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise coping planning). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.p-value: 0.0365Mixed Models Analysis
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Effect of the Intervention on Physical Activity Levels as Measured by Maintenance Self-efficacy | 2.95 score on a scale | Standard Error 0.05 |
Comparison: The secondary outcomes are hypothesized mediators of the effect of exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise maintenance self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichtomous mental imagery variable in this analysis.p-value: 0.007Mixed Models Analysis
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Effect of the Intervention on Physical Activity Levels as Measured by Perceived Vividness of Self-regulatory Imagery | 3.36 score on a scale | Standard Error 0.04 |
Comparison: The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise imagery vividness). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.p-value: 0.8661Mixed Models Analysis
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Effect of the Intervention on Physical Activity Levels as Measured by Recovery Self-efficacy | 3.26 score on a scale | Standard Error 0.05 |
Comparison: The secondary outcomes are hypothesized mediators of the effect of exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise recovery self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichtomous mental imagery variable in this analysis.p-value: 0.8793Mixed Models Analysis