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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
149

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Accelerometer
Participants use an accelerometer to monitor their steps activity
Behavioral: Step goal
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.
Device: Accelerometer
Participants use an accelerometer to monitor their steps activity
Behavioral: Step goal
Participants are given a daily step goal to aim for
Behavioral: Consistent contexts
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.
Device: Accelerometer
Participants use an accelerometer to monitor their steps activity
Behavioral: Step goal
Participants are given a daily step goal to aim for
Behavioral: Inconsistent contexts
Participants plan to take steps in contexts that vary from day to day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brandeis University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 24, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 24, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BrandeisU

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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