Sedentary LifestyleNCT03124563
Planning the Next Steps: Using an Implementation Intention Approach to Increase Daily Walking
A study testing Implementation Intention Condition in people with Sedentary Lifestyle and Self Efficacy, run by Brandeis University.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Self Efficacy, Control Locus
- What is being tested?
- Implementation Intention Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently working full time
- Not engaged in regular exercise
- 35 years of age or older
Who cannot join
- Not healthy enough to engage in a walking intervention
About this study
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.
Read the 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.
- Conditions
- Sedentary Lifestyle, Self Efficacy, Control Locus
- Being tested
- Control Group, Implementation Intention Condition
- Keywords
- Exercise, Health Behavior, Aging
- Medical subject headings
- Sedentary Behavior, Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupBehavioural
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.
Implementation Intention ConditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Control Group |
| 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. Receives: Behavioral: Implementation Intention Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps
Weekly average of daily step counts with Fitbit (averaged across 7 days at Week 1 and averaged across 7 days at Week 5).
Measured: 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).
Measured: Week 1 & Week 5
Secondary outcomes (4)
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.
Measured: 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.
Measured: Baseline (Pre-Test) and Week 5 (Post-Test )
Exercise Self-efficacy
Amount of confidence in ability to exercise.
Measured: 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.
Measured: Baseline (Pre-Test) and Week 5 (Post-Test )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study startJun 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brandeis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margie Lachman, Ph.D., Principal investigator, Brandeis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124563
- Sponsor's protocol ID
- WalkingIntentions #15147
- Status last verified
- Jul 2018
- First submitted
- 13 Apr 2017
- Last updated
- 14 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28391279Robinson, 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Planning the Next Steps: Using an Implementation Intention Approach to Increase Daily Walking
- ClinicalTrials.gov ID
- NCT03124563
- Acronym / sponsor ID
- WalkingIntentions #15147
- Conditions
- Sedentary Lifestyle, Self Efficacy, Control Locus
- Keywords
- Exercise, Health Behavior, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Brandeis UniversityUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Posted 14 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Behavioral: Control GroupParticipants 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. |
| Implementation Intention Condition | Experimental | Behavioral: Implementation Intention ConditionParticipants 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently working full time
- Not engaged in regular exercise
- 35 years of age or older
Key exclusion criteria (1 listed)
- Not healthy enough to engage in a walking intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control GroupParticipants 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. | Behavioural | Control group |
| Implementation Intention ConditionParticipants 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. | Behavioural | Implementation Intention Condition |
Primary outcome
Steps
Time frame: 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
Time frame: 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).
4 secondary outcomes
Cognitive Composite Score
Time frame: Baseline (Pre-Test) and Week 5 (Post-Test )
Exercise Control Beliefs
Time frame: Baseline (Pre-Test) and Week 5 (Post-Test )
Exercise Self-efficacy
Time frame: Baseline (Pre-Test) and Week 5 (Post-Test )
Exercise Self-efficacy Beliefs - Time Composite
Time frame: Baseline (Pre-Test) and Week 5 (Post-Test )
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28391279Robinson 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.
- BackgroundRobinson, 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.
- Individual participant dataSharing planned: No
Related trials for Sedentary Lifestyle
Recruiting
Real-time Engagement for Learning to Effectively Control Type 2 Diabetes
Diabetes Mellitus, Type 2, Lifestyle
Not yet recruitingEarly Phase 1
Kava Aging and Mobility Study
Old Adults, Sleep Quality
Recruiting
Polarized Aerobic Training and Vascular Adaptations in Apparently Healthy Individuals
Sedentary Lifestyle
Recruiting
Families Implementing Good Health Traditions for Life
Diabetes, Chronic Disease
Not yet recruitingObservational study
Effects of Sustainable Exercise Habits in University Students
Sedentary Lifestyle, Physical Activity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margie Lachman, Ph.D. principal investigator
Brandeis University
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Intention Condition in people with Sedentary Lifestyle and Self Efficacy, run by Brandeis University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steps (time frame: Week 1 & Week 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03124563, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019; AzTrials last refreshed its copy on 27 Oct 2026.