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The study goal is to design an intervention utilizing implementation intentions to help participants prospectively plan and visualize ways to increase activity for the next day among working adults who do not currently exercise or use an activity monitor. Investigators will assess the level of and changes in physical activity, and how this relates to various individual factors that are related to exercise and health, including self-efficacy, control beliefs, and cognition.
The 5-week study consists of a 1-week baseline, where participants are asked to wear a Fitbit to document the number of steps taken that day to establish an objective measurement of steps before the intervention began. In the intervention condition, after the baseline week, during weeks 2 to 5, this condition is prompted with an email each evening for four weeks to review their schedules for the following day and identify time slots where they could add activity. They are given instructions for providing a detailed calendar of appointments and open slots for the next day using a simple daily planner. The planning implementation intention manipulation involves recording specific information about when, where, and how they will add steps to their day. They are provided with maps near their home and work with specific information about distances, estimated time to walk between different points, and number of steps for specific routes to help them in planning for specific routes.The control condition is matched for how much contact they have with the research staff (called and emailed the same amount of times) and also wear the Fitbit daily. The only difference from the intervention group is that they do not get the daily planning instructions or maps for the implementation intention strategy treatment. All activity data from the Fitbit was deidentified and aggregated with an online platform called Fitabase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Experimental | Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. |
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| Implementation Intention Condition | Experimental | Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Group | Behavioral | Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. |
| Measure | Description | Time Frame |
|---|---|---|
| Steps | Weekly average of daily step counts with Fitbit (averaged across 7 days at Week 1 and averaged across 7 days at Week 5). | Week 1 & Week 5 |
| Activity Intensity | Weekly average of daily time spent in moderate to vigorous intensity activity (averaged across 7 days at Week 1 and averaged across 7 days at Week 5). | Week 1 & Week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Composite Score | Z-score composite on the Brief Test of Adult Cognition by Telephone (BTACT). Individual tests scores were first standardized to z-scores. The z-score composite was calculated by averaging the z-scores of the 5 tests: word list immediate, word list delayed, backwards counting, digits backwards, and category fluency. Post-test z-scores were standardized based on the mean and s.d. of the pretest scores. A higher z-score is indicative of better cognitive functioning. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margie Lachman, Ph.D. | Brandeis University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28391279 | Background | Robinson SA, Lachman ME. Perceived Control and Aging: A Mini-Review and Directions for Future Research. Gerontology. 2017;63(5):435-442. doi: 10.1159/000468540. Epub 2017 Apr 8. | |
| Background | Robinson, S. A. & Lachman, M. E. (2016). Perceived Control and Behavior Change: A Personalized Approach. In F. Infurna & J. Reich (Eds.), Perceived Control: Theory, Research, and Practice in the First 50 Years (pp. 201-227). New York, New York: Oxford University Press. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. |
| FG001 | Implementation Intention Condition | Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Participants will wear a Fitbit Zip to record their daily activity data, which was deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Steps | Weekly average of daily step counts with Fitbit (averaged across 7 days at Week 1 and averaged across 7 days at Week 5). | Analysis population based on participants that successfully synced their Fitbit and did not withdraw before the start of the study. | Posted | Mean | Standard Deviation | Daily Steps | Week 1 & Week 5 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. Assigned Intervention - Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Margie E. Lachman | Brandeis University | 7817363255 | lachman@brandeis.edu |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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The participants are aware of the nature of the intervention. They are not aware if they are the experimental or control group.
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| Implementation Intention Condition | Behavioral | Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire. |
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| Baseline (Pre-Test) and Week 5 (Post-Test ) |
| Exercise Control Beliefs | Degree of perceived control over Exercise. Range from 1 (Strongly agree) to 5 (strongly agree). Reverse coded so that a higher number indicates more perceived control over exercise. | Baseline (Pre-Test) and Week 5 (Post-Test ) |
| Exercise Self-efficacy | Amount of confidence in ability to exercise. | Baseline (Pre-Test) and Week 5 (Post-Test ) |
| Exercise Self-efficacy Beliefs - Time Composite | Amount of confidence in ability to exercise when facing time constraints. Range from 1 (Very Sure) to 4 (Not sure at all). Reverse coded so that a higher number indicates more self-efficacy. 3 items, summed to form time-relevant composite scale. | Baseline (Pre-Test) and Week 5 (Post-Test ) |
| BG001 | Implementation Intention Condition | Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Implementation Intention Condition | Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire. |
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| Primary | Activity Intensity | Weekly average of daily time spent in moderate to vigorous intensity activity (averaged across 7 days at Week 1 and averaged across 7 days at Week 5). | Analysis population based on participants that successfully synced their Fitbit and did not withdraw before the start of the study. | Posted | Mean | Standard Deviation | Minutes | Week 1 & Week 5 |
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| Secondary | Cognitive Composite Score | Z-score composite on the Brief Test of Adult Cognition by Telephone (BTACT). Individual tests scores were first standardized to z-scores. The z-score composite was calculated by averaging the z-scores of the 5 tests: word list immediate, word list delayed, backwards counting, digits backwards, and category fluency. Post-test z-scores were standardized based on the mean and s.d. of the pretest scores. A higher z-score is indicative of better cognitive functioning. | Analysis population based on those who completed cognitive test at each testing point. | Posted | Mean | Standard Deviation | Z-score | Baseline (Pre-Test) and Week 5 (Post-Test ) |
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| Secondary | Exercise Control Beliefs | Degree of perceived control over Exercise. Range from 1 (Strongly agree) to 5 (strongly agree). Reverse coded so that a higher number indicates more perceived control over exercise. | Analysis population based on those who completed Control Beliefs over Exercise questionnaire at each testing point. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pre-Test) and Week 5 (Post-Test ) |
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| Secondary | Exercise Self-efficacy | Amount of confidence in ability to exercise. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pre-Test) and Week 5 (Post-Test ) |
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| Secondary | Exercise Self-efficacy Beliefs - Time Composite | Amount of confidence in ability to exercise when facing time constraints. Range from 1 (Very Sure) to 4 (Not sure at all). Reverse coded so that a higher number indicates more self-efficacy. 3 items, summed to form time-relevant composite scale. | Analysis population based on those who completed Exercise Self-efficacy Beliefs questionnaire at each testing point. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pre-Test) and Week 5 (Post-Test ) |
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| 32 |
| 0 |
| 32 |
| EG001 | Implementation Intention Condition | Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire. | 0 | 30 | 0 | 30 |
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| D008722 | Methods |