- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03272438
Schedule Intervention to Increase Sustainable Walking Activity in Midlife Working Adults
February 13, 2025 updated by: Jane Ebert, Brandeis University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
149
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Waltham, Massachusetts, United States, 02453-2728
- Brandeis University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
36 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: No schedule control
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.
|
Participants use an accelerometer to monitor their steps activity
Participants are given a daily step goal to aim for
|
|
Experimental: Consistent schedule condition
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.
|
Participants use an accelerometer to monitor their steps activity
Participants are given a daily step goal to aim for
Participants plan to take steps in contexts that are similar from day to day
|
|
Active Comparator: Inconsistent schedule condition
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.
|
Participants use an accelerometer to monitor their steps activity
Participants are given a daily step goal to aim for
Participants plan to take steps in contexts that vary from day to day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity
Time Frame: Daily for 9 weeks
|
Number of steps taken each day as measured on accelerometer
|
Daily for 9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measures of well being
Time Frame: Before and after intervention (5 weeks apart), and at followup (4 weeks later)
|
Feelings of satisfaction with life, perceived stress, mood and sleep quality
|
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
|
Perceived ability and ease of being physically active
|
Weekly for 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jane Ebert, PhD, Brandeis University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 13, 2018
Primary Completion (Actual)
July 24, 2019
Study Completion (Actual)
July 24, 2019
Study Registration Dates
First Submitted
April 25, 2017
First Submitted That Met QC Criteria
September 1, 2017
First Posted (Actual)
September 5, 2017
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 13, 2025
Last Verified
September 1, 2022
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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