Physical ActivityNCT03272438
Schedule Intervention to Increase Sustainable Walking Activity in Midlife Working Adults
A study testing Accelerometer, Step goal and Consistent contexts in people with Physical Activity, run by Brandeis University at 1 site in United States.
Trial summary
While people commonly understand that regular physical exercise conveys many health benefits, only 20% of U.S. adults take regular exercise and they have difficulty maintaining new healthy behaviors. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Accelerometer, Step goal and Consistent contexts
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2018to 24 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- currently working 3 or more days (or 24 hours or more) per week;
- physically minimally active (as determined using the International Physical Activity Questionnaire (IPAQ)
Who cannot join
- a recent (within the past 6 months) cardiovascular event, or fall.
- anyone who already exercises regularly, 3 times a week or more for at least 30 minutes, will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Brandeis University
Waltham, Massachusetts, 02453-2728
About this study
Official title: Using a Schedule Intervention to Increase Sustainable Walking Activity in Midlife
While people commonly understand that regular physical exercise conveys many health benefits, only 20% of U.S. adults take regular exercise and they have difficulty maintaining new healthy behaviors. The goal of this study is to use a planning intervention to help establish and maintain a daily step regimen in working midlife adults. The investigators will ask participants to plan when, where, and how to act on a daily walking goal in conjunction with a scheduling intervention to increase the chances that they will maintain this new regimen. The effectiveness of three different scheduling interventions will be compared.
Read the detailed description
While people commonly understand that regular physical exercise conveys many health benefits, only 20% of U.S. adults take regular exercise and they have difficulty maintaining new healthy behaviors. The goal of this study is to use a planning intervention to help establish and maintain a daily step regimen in working midlife adults. The investigators will ask participants to plan when, where, and how to act on a daily walking goal in conjunction with a scheduling intervention to increase the chances that they will maintain this new regimen. Participants will be randomly assigned to one of three conditions: consistent schedule, inconsistent schedule, no schedule. All participants will be provided with an accelerometer to measure their daily activity and as a behavioral support for our intervention and they will be given a step goal. The goal given to each individual will be to increase immediately their daily steps to a level based on recommended guidelines (e.g., Hill, Wyatt, Reed, and Peters, 2003). The investigators will test which version of the scheduling intervention is most successful for increasing and maintaining step counts. It is predicted that participants in the consistent schedule condition will increase their step count more than those participants in the no schedule control condition, and that they will maintain this activity for a longer period after the intervention period is complete than those participants in the inconsistent schedule condition.
- Conditions
- Physical Activity
- Being tested
- Accelerometer, Step goal, Consistent contexts, Inconsistent contexts
- Keywords
- steps, goals
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometerDevice
Participants use an accelerometer to monitor their steps activity
Step goalBehavioural
Participants are given a daily step goal to aim for
Consistent contextsBehavioural
Participants plan to take steps in contexts that are similar from day to day
Inconsistent contextsBehavioural
Participants plan to take steps in contexts that vary from day to day
| Study group | Role | What they receive |
|---|---|---|
| No schedule control | Active comparator | This group will receive an accelerometer and daily step goal. They will monitor their steps over the 9 week duration of the study. They will also monitor their steps over the 9 week duration of the study. They will have the same level of contact as the other two conditions. Receives: Device: Accelerometer; Behavioral: Step goal |
| Consistent schedule condition | Experimental | This group will receive an accelerometer and daily step goal. They will monitor their steps over the 9 week duration of the study. They will have the same level of contact as the other two conditions. In addition they will plan when, where, and how they will take steps in consistent contexts, i.e., that are very similar from day to day. Receives: Device: Accelerometer; Behavioral: Step goal; Behavioral: Consistent contexts |
| Inconsistent schedule condition | Active comparator | This group will receive an accelerometer and daily step goal. They will monitor their steps over the 9 week duration of the study. They will have the same level of contact as the other two conditions. In addition they will plan when, where, and how they will take steps in inconsistent contexts, i.e., that vary from day to day. Receives: Device: Accelerometer; Behavioral: Step goal; Behavioral: Inconsistent contexts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Number of steps taken each day as measured on accelerometer
Measured: Daily for 9 weeks
Secondary outcomes (2)
Measures of well being
Feelings of satisfaction with life, perceived stress, mood and sleep quality
Measured: Before and after intervention (5 weeks apart), and at followup (4 weeks later)
Physical activity self-efficacy and ease
Perceived ability and ease of being physically active
Measured: Weekly for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start13 Apr 2018
- Primary completion24 Jul 2019
- Study completion24 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three between-subjects conditions: consistent schedule, inconsistent schedule, no schedule. The study is a longitudinal study over 9 weeks, including a baseline week, a 4-week intervention and a follow-up assessment 4 weeks after the intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brandeis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Ebert, Brandeis University
- Investigators
- Jane Ebert, PhD, Principal investigator, Brandeis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272438
- Sponsor's protocol ID
- BrandeisU
- Status last verified
- Sep 2022
- First submitted
- 25 Apr 2017
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hill JO, Wyatt HR, Reed GW, Peters JC. Obesity and the environment: where do we go from here? Science. 2003 Feb 7;299(5608):853-5. doi: 10.1126/science.1079857.
PubMed 12574618
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Schedule Intervention to Increase Sustainable Walking Activity in Midlife
- ClinicalTrials.gov ID
- NCT03272438
- Acronym / sponsor ID
- BrandeisU
- Conditions
- Physical Activity
- Keywords
- steps, goals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Brandeis UniversityUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While people commonly understand that regular physical exercise conveys many health benefits, only 20% of U.S. adults take regular exercise and they have difficulty maintaining new healthy behaviors. The goal of this study is to use a planning intervention to help establish and maintain a daily step regimen in working midlife adults. The investigators will ask participants to plan when, where, and how to act on a daily walking goal in conjunction with a scheduling intervention to increase the chances that they will maintain this new regimen. The effectiveness of three different scheduling interventions will be compared.
Detailed description
While people commonly understand that regular physical exercise conveys many health benefits, only 20% of U.S. adults take regular exercise and they have difficulty maintaining new healthy behaviors. The goal of this study is to use a planning intervention to help establish and maintain a daily step regimen in working midlife adults. The investigators will ask participants to plan when, where, and how to act on a daily walking goal in conjunction with a scheduling intervention to increase the chances that they will maintain this new regimen. Participants will be randomly assigned to one of three conditions: consistent schedule, inconsistent schedule, no schedule. All participants will be provided with an accelerometer to measure their daily activity and as a behavioral support for our intervention and they will be given a step goal. The goal given to each individual will be to increase immediately their daily steps to a level based on recommended guidelines (e.g., Hill, Wyatt, Reed, and Peters, 2003). The investigators will test which version of the scheduling intervention is most successful for increasing and maintaining step counts. It is predicted that participants in the consistent schedule condition will increase their step count more than those participants in the no schedule control condition, and that they will maintain this activity for a longer period after the intervention period is complete than those participants in the inconsistent schedule condition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three between-subjects conditions: consistent schedule, inconsistent schedule, no schedule. The study is a longitudinal study over 9 weeks, including a baseline week, a 4-week intervention and a follow-up assessment 4 weeks after the intervention.
| Arm | Type | Receives |
|---|---|---|
| No schedule control | Active comparator | Device: Accelerometer, Behavioral: Step goalThis group will receive an accelerometer and daily step goal. They will monitor their steps over the 9 week duration of the study. They will also monitor their steps over the 9 week duration of the study. They will have the same level of contact as the other two conditions. |
| Consistent schedule condition | Experimental | Device: Accelerometer, Behavioral: Step goal, Behavioral: Consistent contextsThis group will receive an accelerometer and daily step goal. They will monitor their steps over the 9 week duration of the study. They will have the same level of contact as the other two conditions. In addition they will plan when, where, and how they will take steps in consistent contexts, i.e., that are very similar from day to day. |
| Inconsistent schedule condition | Active comparator | Device: Accelerometer, Behavioral: Step goal, Behavioral: Inconsistent contextsThis group will receive an accelerometer and daily step goal. They will monitor their steps over the 9 week duration of the study. They will have the same level of contact as the other two conditions. In addition they will plan when, where, and how they will take steps in inconsistent contexts, i.e., that vary from day to day. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- currently working 3 or more days (or 24 hours or more) per week;
- physically minimally active (as determined using the International Physical Activity Questionnaire (IPAQ)
Key exclusion criteria (2 listed)
- a recent (within the past 6 months) cardiovascular event, or fall.
- anyone who already exercises regularly, 3 times a week or more for at least 30 minutes, will be excluded
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 |
|---|---|---|
| AccelerometerParticipants use an accelerometer to monitor their steps activity | Device | Consistent schedule condition, Inconsistent schedule condition, No schedule control |
| Step goalParticipants are given a daily step goal to aim for | Behavioural | Consistent schedule condition, Inconsistent schedule condition, No schedule control |
| Consistent contextsParticipants plan to take steps in contexts that are similar from day to day | Behavioural | Consistent schedule condition |
| Inconsistent contextsParticipants plan to take steps in contexts that vary from day to day | Behavioural | Inconsistent schedule condition |
Primary outcome
Physical activity
Time frame: Daily for 9 weeks
Number of steps taken each day as measured on accelerometer
2 secondary outcomes
Measures of well being
Time frame: Before and after intervention (5 weeks apart), and at followup (4 weeks later)
Physical activity self-efficacy and ease
Time frame: Weekly for 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Background: PubMed 12574618Hill JO, Wyatt HR, Reed GW, Peters JC. Obesity and the environment: where do we go from here? Science. 2003 Feb 7;299(5608):853-5. doi: 10.1126/science.1079857.
- Individual participant dataSharing planned: No
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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.
Jane Ebert, PhD principal investigator
Brandeis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerometer, Step goal and Consistent contexts in people with Physical Activity, run by Brandeis University at 1 site in United States.
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 2 inclusion and 2 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 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical activity (time frame: Daily for 9 weeks). 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 NCT03272438, which also lists 1 linked publication.
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 17 Feb 2025.