- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06172933
A Text- and Audio-based Intervention to Promote Physical Activity in Midlife
April 9, 2026 updated by: Christopher Celano, Massachusetts General Hospital
This is a randomized, controlled pilot trial (N=30) to examine the feasibility, acceptability, and preliminary efficacy of the Move with Meaning program, an 8- week, text message- and audio-based intervention to promote physical activity in midlife adults.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, controlled pilot trial to examine the feasibility, acceptability, and preliminary efficacy of the Move with Meaning program, an 8- week, text message- and audio-based intervention to promote physical activity in midlife adults.
In Move with Meaning, participants will listen to weekly audio sessions and complete twice weekly text message sessions, in which they will set a weekly physical activity goal.
The primary outcome is feasibility (measured by number of successful text message sessions sent).
Secondary outcomes include acceptability and preliminary impact on physical activity, psychological health-, and physical health-related outcomes.
Study Type
Interventional
Enrollment (Estimated)
30
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
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Midlife adults (aged 45-64 years at the time of enrollment)
- Suboptimal physical activity (<150 minutes of moderate to vigorous physical activity, measured by accelerometer)
- Access to a phone capable of receiving text messages and listening to audio files (i.e., a smartphone)
Exclusion Criteria:
- An unrelated condition limiting physical activity
- Participation in any other programs focused on cardiac prevention or well-being
- A cognitive disturbance precluding participation or informed consent
- Current pregnancy
- Inability to speak/write fluently in English
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Move with Meaning
In Move with Meaning, participants will engage in twice weekly, interactive text message sessions, which are accompanied by audio content to promote engagement in the program.
In the first session of each week, participants will review their physical activity goal and positive psychology topic from last week, then learn about a new positive psychology and physical activity topic and ultimately set a new physical activity goal for the week.
In the second session, participants will either be reminded of the content of the audio file and the goal they set earlier that week.
The program will run for eight weeks.
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Participants will engage in twice weekly text message sessions, will listen to a weekly audio session, and will work towards a physical activity goal each week, for a total of eight weeks.
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No Intervention: Wait-list control
Participants in the wait-list control condition will engage in usual medical care for eight weeks, then will complete the Move with Meaning program.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of text message sessions successfully delivered
Time Frame: Weekly over 8 weeks
|
The automated platform will record rates of successful text message delivery.
|
Weekly over 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of audio sessions completed by participants
Time Frame: Weekly over 8 weeks
|
We will record the number of sessions in which participants engaged (e.g., responded to a text message), out of a total of 8 sessions.
|
Weekly over 8 weeks
|
|
Change in overall physical activity (in steps/day)
Time Frame: Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)
|
Physical activity (steps) will be measured via an Actigraph accelerometer.
We will use established accelerometer protocols to measure the mean number of steps taken per day at each time point.
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Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)
|
|
Change in moderate to vigorous physical activity (MVPA; in mean minutes/day)
Time Frame: Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)
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MVPA (reported in mean minutes of MVPA/day) will be measured via an Actigraph accelerometer and recorded in mean minutes/day.
|
Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)
|
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Change in sedentary time (in mean minutes/day)
Time Frame: Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)
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Sedentary time (mean minutes/day) will be measured via Actigraph accelerometer.
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Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)
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Change in self-reported physical activity (International Physical Activity Questionnaire [IPAQ]; in metabolic equivalent-minutes/week)
Time Frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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This will be measured via the International Physical Activity Questionnaire (IPAQ) as a secondary measure of physical activity.
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Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Session utility
Time Frame: Weekly over 8 weeks
|
Participants will rate the utility of each session, measured on a 10-point Likert scale.
Higher scores indicate greater utility.
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Weekly over 8 weeks
|
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Change in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items)
Time Frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Positive affect (our main psychological outcome given its links to health outcomes and sensitivity to change) will be assessed via the Positive and Negative Affect Schedule (PANAS) positive affect items.
PANAS scores range from 10-50, with higher scores indicating higher levels of positive affect.
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Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Change in optimism (Life Orientation Test - Revised [LOT-R])
Time Frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Optimism will be measured using the Life Orientation Test - Revised (LOT-R), a frequently used 6-item instrument that assesses dispositional optimism.
LOT-R scores range from 0-24, with higher scores indicating higher levels of optimism.
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Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Change in depressive symptoms (depression subscale of the Hospital Anxiety and Depression Scale [HADS]).
Time Frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Depressive symptoms will be measured using the 7-item depression subscale of the Hospital Anxiety and Depression Scale (HADS).
The depression subscale of the HADS ranges from 0-21, with higher scores indicating higher levels of depression.
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Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Change in anxiety (anxiety subscale of the Hospital Anxiety and Depression Scale [HADS])
Time Frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Anxiety will be measured using the 7-item anxiety subscale of the Hospital Anxiety and Depression Scale (HADS).
The anxiety subscale of the HADS ranges from 0-21, with higher scores indicating higher levels of anxiety.
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Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Change in exercise self-efficacy (Self-Efficacy for Exercise scale [SEE])
Time Frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Exercise self-efficacy will be measured via the Self-Efficacy for Exercise (SEE) scale.
SEE scores range from 0-90, with higher scores indicating higher levels of self-efficacy for exercise.
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Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Change in perceived social support (Multidimensional Scale of Perceived Social Support)
Time Frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Perceived social support will be measured by the Multidimensional Scale of Perceived Social Support (MSPSS).
MSPSS scores range from 1-7, with higher scores indicating higher levels of perceived social support.
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Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Change in internal health locus of control (Multidimensional Health Locus of Control [MHLC] scale)
Time Frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Internal locus/sense of control will be measured using the Multidimensional Health Locus of Control (MHLC) scale.
The internal locus of control score from the MHLC ranges from 6-36, with higher scores indicating greater internal locus of control.
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Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Change in positive affect during activity (Physical Activity Enjoyment Scale)
Time Frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Positive affect during activity will be measured using the Physical Activity Enjoyment Scale.
Physical Activity Enjoyment Scale scores range from 18-126, with higher scores indicating higher levels of enjoyment during activity.
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Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christopher M Celano, MD, Massachusetts General Hospital
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)
September 23, 2024
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
December 7, 2023
First Submitted That Met QC Criteria
December 7, 2023
First Posted (Actual)
December 15, 2023
Study Record Updates
Last Update Posted (Actual)
April 14, 2026
Last Update Submitted That Met QC Criteria
April 9, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023P003312
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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