Control Locus, Sedentary Lifestyle, Self Efficacy
Conditions
Keywords
Exercise, Health Behavior, Aging
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALControl Group
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.
BEHAVIORALImplementation Intention Condition
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.
Sponsors
Brandeis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
The participants are aware of the nature of the intervention. They are not aware if they are the experimental or control group.
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Currently working full time * Not engaged in regular exercise * 35 years of age or older
Exclusion criteria
* Not healthy enough to engage in a walking intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steps | Week 1 & Week 5 | Weekly average of daily step counts with Fitbit (averaged across 7 days at Week 1 and averaged across 7 days at Week 5). |
| Activity Intensity | Week 1 & Week 5 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Composite Score | Baseline (Pre-Test) and Week 5 (Post-Test ) | 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. |
| Exercise Control Beliefs | Baseline (Pre-Test) and Week 5 (Post-Test ) | 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. |
| Exercise Self-efficacy | Baseline (Pre-Test) and Week 5 (Post-Test ) | Amount of confidence in ability to exercise. |
| Exercise Self-efficacy Beliefs - Time Composite | Baseline (Pre-Test) and Week 5 (Post-Test ) | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 31 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Implementation Intention Condition | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 29 Participants | 59 Participants |
| Age, Continuous | 46.33 years STANDARD_DEVIATION 8.03 | 52.22 years STANDARD_DEVIATION 7.68 | 49.37 years STANDARD_DEVIATION 8.33 |
| Region of Enrollment United States | 31 participants | 32 participants | 63 participants |
| Sex: Female, Male Female | 22 Participants | 24 Participants | 46 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 30 |
| serious Total, serious adverse events | 0 / 32 | 0 / 30 |
Outcome results
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).
Time frame: Week 1 & Week 5
Population: Analysis population based on participants that successfully synced their Fitbit and did not withdraw before the start of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Activity Intensity | Week 5 | 18.51 Minutes | Standard Deviation 25.84 |
| Control Group | Activity Intensity | Week 1 | 18.71 Minutes | Standard Deviation 20.31 |
| Implementation Intention Condition | Activity Intensity | Week 1 | 22.25 Minutes | Standard Deviation 22.05 |
| Implementation Intention Condition | Activity Intensity | Week 5 | 32.23 Minutes | Standard Deviation 30.73 |
p-value: 0.034Mixed Models Analysis
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).
Time frame: Week 1 & Week 5
Population: Analysis population based on participants that successfully synced their Fitbit and did not withdraw before the start of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Steps | Week 1 | 6337.77 Daily Steps | Standard Deviation 2207.44 |
| Control Group | Steps | Week 5 | 6109.46 Daily Steps | Standard Deviation 3308.75 |
| Implementation Intention Condition | Steps | Week 1 | 6966.06 Daily Steps | Standard Deviation 2818.05 |
| Implementation Intention Condition | Steps | Week 5 | 8900.35 Daily Steps | Standard Deviation 4416.04 |
p-value: =0.006Mixed Models Analysis
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.
Time frame: Baseline (Pre-Test) and Week 5 (Post-Test )
Population: Analysis population based on those who completed cognitive test at each testing point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Cognitive Composite Score | Pre-Test | -.17 Z-score | Standard Deviation 0.7 |
| Control Group | Cognitive Composite Score | Post-Test | .21 Z-score | Standard Deviation 0.5 |
| Implementation Intention Condition | Cognitive Composite Score | Pre-Test | .17 Z-score | Standard Deviation 0.48 |
| Implementation Intention Condition | Cognitive Composite Score | Post-Test | .65 Z-score | Standard Deviation 0.52 |
p-value: 0.065Mixed Models Analysis
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.
Time frame: Baseline (Pre-Test) and Week 5 (Post-Test )
Population: Analysis population based on those who completed Control Beliefs over Exercise questionnaire at each testing point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Exercise Control Beliefs | Pre-Test | 4.26 units on a scale | Standard Deviation 0.52 |
| Control Group | Exercise Control Beliefs | Post-Test | 4.32 units on a scale | Standard Deviation 0.54 |
| Implementation Intention Condition | Exercise Control Beliefs | Pre-Test | 4.26 units on a scale | Standard Deviation 0.72 |
| Implementation Intention Condition | Exercise Control Beliefs | Post-Test | 3.90 units on a scale | Standard Deviation 0.85 |
p-value: 0.308Mixed Models Analysis
Secondary
Exercise Self-efficacy
Amount of confidence in ability to exercise.
Time frame: Baseline (Pre-Test) and Week 5 (Post-Test )
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Exercise Self-efficacy | Pre-test | 2.15 units on a scale | Standard Deviation 0.99 |
| Control Group | Exercise Self-efficacy | Post-test | 2.16 units on a scale | Standard Deviation 0.86 |
| Implementation Intention Condition | Exercise Self-efficacy | Pre-test | 2.19 units on a scale | Standard Deviation 0.81 |
| Implementation Intention Condition | Exercise Self-efficacy | Post-test | 2.29 units on a scale | Standard Deviation 0.92 |
p-value: 0.349ANOVA
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.
Time frame: Baseline (Pre-Test) and Week 5 (Post-Test )
Population: Analysis population based on those who completed Exercise Self-efficacy Beliefs questionnaire at each testing point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Exercise Self-efficacy Beliefs - Time Composite | Pre-Test | 1.96 units on a scale | Standard Deviation 1.05 |
| Control Group | Exercise Self-efficacy Beliefs - Time Composite | Post-Test | 1.94 units on a scale | Standard Deviation 0.89 |
| Implementation Intention Condition | Exercise Self-efficacy Beliefs - Time Composite | Pre-Test | 1.90 units on a scale | Standard Deviation 0.75 |
| Implementation Intention Condition | Exercise Self-efficacy Beliefs - Time Composite | Post-Test | 2.30 units on a scale | Standard Deviation 0.9 |
p-value: 0.022Mixed Models Analysis