Text Messaging to Increase Activity in Midlife (MASTERY)

August 11, 2026 updated by: Jeff C. Huffman, MD, Massachusetts General Hospital

A Randomized Pilot Trial of a Multicomponent Interactive Text Message Intervention to Promote Physical Activity in Midlife Adults

This is a randomized controlled pilot trial of a text message intervention to promote physical activity in midlife adults (MASTERY), compared to an attention-matched control condition. The MASTERY intervention utilizes two-way text message sessions once-weekly for 12 weeks focusing on performing activities to enhance well being, setting physical activity goals, and learning techniques to reduce midlife-specific stress.

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

This is a randomized controlled pilot trial of a multipronged intervention to promote physical activity in midlife adults (MASTERY), compared to an attention-matched control condition. In MASTERY, participants will have interactive, two-way text message 'sessions' (5-10 minutes of two-way text communication with an automated text-message program) once weekly for 12 weeks. The messages will focus on 3 distinct areas in the same order each week: (1) well-being-based skills and assigned activities, customized for midlife adults, (2) physical activity content focused on setting and reaching weekly activity goals, and (3) specific skills to manage midlife-related stressors that act as barriers to activity. The primary outcome is objectively measured moderate to vigorous physical activity (MVPA). Secondary outcomes include feasibility and acceptability and other activity-related, psychological, and functional outcomes at 12 weeks.

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.
116

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.
  • Phase 1

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
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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

45 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Midlife status (age 45-64 at enrollment).
  2. Low baseline physical activity (≤150 minutes/week of MVPA]) as initially self-reported via the well-validated IPAQ and then confirmed via accelerometer after 7 days of wear.

Exclusion Criteria:

  1. Existing coronary artery disease (CAD; diagnosed via cardiac catheterization using standard coronary artery stenosis definitions or prior ACS).
  2. An unrelated condition limiting physical activity (e.g., ambulation with a cane or walker, recent or planned surgery, or other condition such that ability to increase moderate to physical activity would be limited).
  3. Participation in any other programs focused on cardiac prevention or well-being (e.g., cardiac rehabilitation).
  4. A cognitive disturbance precluding participation or informed consent, assessed using a six-item screen7 designed to assess suitability for research participation.
  5. Inability to speak/write fluently in English.
  6. No access to a text message-capable phone.

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

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.
Experimental: MASTERY Intervention
Participants will complete a positive psychology activity, work towards a physical activity goal, and use a stress reduction technique, then will complete weekly text message sessions. In the first six weeks, participants will review the activities they performed the prior week, be introduced to new material, choose activities to perform that week, and set a new physical activity goal during the text message sessions. In the final 6 weeks, participants will review progress towards prior goals, set new physical activity goals, and choose positive psychology and stress reduction skills to use that week. Finally, over the course of the program participants will complete three brief calls with a study trainer to discuss progress.
Behavioral: MASTERY
In MASTERY, participants will have interactive, two-way text message 'sessions' (5-10 minutes of two-way text communication with an automated text-message program) once weekly for 12 weeks. Furthermore, study trainers will conduct 4 brief calls with participants (Weeks 1, 4, 7, and 12) to introduce the program, assess progress, answer questions, and provide support.
Active Comparator: Attentional control
Participants will receive the same physical activity component noted in MASTERY along with added messages providing education and guidance about physical activity, from our past work. Control participants will not receive PP or midlife-related content.
Behavioral: Attentional Control
Participants in the control condition will also receive text messages once per week. To ensure time matching, the program will have 4 phone check-ins (on physical activity) as in MASTERY.

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
Change in Moderate-Vigorous Physical Activity [MVPA]
Time Frame: Baseline, 6 weeks, 12 weeks
ActiGraph accelerometers are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at baseline, 6 weeks, and 12 weeks. We will report change from baseline to 6 weeks and 12 weeks in the average number of minutes of MVPA performed per day.
Baseline, 6 weeks, 12 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
Proportion of Text Message Sessions Completed
Time Frame: Weekly over 12 weeks.
To assess the feasibility of the MASTERY intervention the automated platform will record rates of the proportion of text message sessions in which participants respond and set a physical activity goal. The "proportion of text message sessions completed" will be calculated by dividing the number of sessions in which participants respond and set a physical activity goal by the total number of sessions initiated by the text message program.
Weekly over 12 weeks.
Mean Utility Ratings of Positive Psychology Text Messages
Time Frame: 6 weeks; 12 weeks
Participants will rate the utility of the positive psychology text message sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful). The mean utility score from the Week 6 and Week 12 assessments was calculated using mixed effects regression, to account for variance both within and between participants.
6 weeks; 12 weeks
Mean Utility Ratings of Physical Activity Text Messages
Time Frame: 6 weeks; 12 weeks
Participants will rate the utility of the physical activity text message sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful). The mean utility score from the Week 6 and Week 12 assessments was calculated using mixed effects regression, to account for variance both within and between participants.
6 weeks; 12 weeks
Mean Utility Ratings of Stress Reduction Text Messages
Time Frame: 6 weeks; 12 weeks
Participants will rate the utility of the stress reduction text message sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful). The mean utility score from the Week 6 and Week 12 assessments was calculated using mixed effects regression, to account for variance both within and between participants.
6 weeks; 12 weeks
Mean Utility Ratings of Phone Check-ins
Time Frame: 12 weeks
Participants will rate the utility of the phone sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful).
12 weeks
Change in Overall Physical Activity
Time Frame: Baseline, 6 weeks, 12 weeks
ActiGraph accelerometers are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at baseline, 6 weeks, and 12 weeks. We will report change from baseline to 6 weeks and 12 weeks in the average number of steps per day.
Baseline, 6 weeks, 12 weeks
Change in Sedentary Time
Time Frame: Baseline, 6 weeks, 12 weeks
ActiGraph accelerometers are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at baseline, 6 weeks, and 12 weeks. We will report change from baseline to 6 weeks and 12 weeks in the average number of minutes of sedentary time per day.
Baseline, 6 weeks, 12 weeks
Change in Self-reported Physical Activity
Time Frame: Baseline, 6 weeks, 12 weeks
The International Physical Activity Questionnaire (IPAQ) is a well-validated 7-day physical activity recall assessment for physical activity. Activity will be measured by the number of MET-minutes of moderate or greater activity per week, and change will be assessed by subtracting the baseline score from the 6- and 12-week scores.
Baseline, 6 weeks, 12 weeks
Change in Positive Affect (Positive Affect Items of the Positive and Negative Affect Schedule [PANAS])
Time Frame: Baseline, 6 weeks, 12 weeks
The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect (Range: 10-50). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate higher levels of positive affect.
Baseline, 6 weeks, 12 weeks
Change in Optimism (Life Orientation Test - Revised [LOT-R])
Time Frame: Baseline, 6 weeks, 12 weeks
The Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate higher levels of optimism.
Baseline, 6 weeks, 12 weeks
Change in Life Satisfaction (Satisfaction With Life Scale [SWLS])
Time Frame: Baseline, 6 weeks, 12 weeks
The Satisfaction with Life Scale is a 5-item scale designed to measure global cognitive judgments of one's life satisfaction (Range: 5-35). Higher scores reflect higher levels of life satisfaction. Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks.
Baseline, 6 weeks, 12 weeks
Change in Depressive Symptoms (Hospital Anxiety and Depression Scale Depression Subscale [HADS-D])
Time Frame: Baseline, 6 weeks, 12 weeks
The Hospital Anxiety and Depression Scale depression subscale (HADS-D) will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate higher levels of depression.
Baseline, 6 weeks, 12 weeks
Change in Anxiety (Hospital Anxiety and Depression Scale Anxiety Subscale [HADS-A])
Time Frame: Baseline, 6 weeks, 12 weeks
The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate higher levels of anxiety.
Baseline, 6 weeks, 12 weeks
Change in Exercise Self-efficacy (Self-efficacy for Exercise Scale [SES])
Time Frame: Baseline, 6 weeks, 12 weeks
The Self-efficacy for Exercise Scale will be used to measure exercise self-efficacy. This is a 9-item scale used to assess an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 20+ minutes per session in the future. (Range: 0-90). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate higher levels of self-efficacy.
Baseline, 6 weeks, 12 weeks
Change in Perceived Constraints (Perceived Constraints Subscale of the MIDUS Sense of Control Measure)
Time Frame: Baseline, 6 weeks, 12 weeks
The 8-item subscale of the MIDUS Sense of Control measure will be used to measure internal locus of control - perceived constraints (Range: 8-56). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Lower scores indicate higher levels of perceived constraints.
Baseline, 6 weeks, 12 weeks
Change in Personal Mastery (Personal Mastery Subscale of the MIDUS Sense of Control Measure)
Time Frame: Baseline, 6 weeks, 12 weeks
The 4-item subscale of the MIDUS Sense of Control measure will be used to measure internal locus of control - personal mastery (Range: 4-28). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate higher levels of personal mastery.
Baseline, 6 weeks, 12 weeks
Change in Function (General Health Questionnaire-12 [GHQ-12])
Time Frame: Baseline, 6 weeks, 12 weeks
The General Health Questionnaire-12 consists of 12 items and assesses function (Range: 0-36). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate worse functional status.
Baseline, 6 weeks, 12 weeks
Change in Mental Health Related Quality of Life (Medical Outcomes Study Short Form-12 Mental Component Score [SF-12 MCS])
Time Frame: Baseline, 6 weeks, 12 weeks
Mental health related quality of life will be assessed via the mental component score of the Medical Outcomes Study SF-12 (Range: 0-100). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate better health-related quality of life.
Baseline, 6 weeks, 12 weeks
Change in Physical Health Related Quality of Life (Medical Outcomes Study Short Form-12 Physical Component Score [SF-12 PCS])
Time Frame: Baseline, 6 weeks, 12 weeks
Physical health related quality of life will be assessed via the physical component score of the Medical Outcomes Study SF-12 (Range: 0-100). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate better health-related quality of life.
Baseline, 6 weeks, 12 weeks
Change in Body Weight
Time Frame: Baseline, 6 weeks, 12 weeks
Body weight (in kilograms) will be measured by nurses. Change will be calculated by subtracting the weight at baseline from the weight at 6 and 12 weeks.
Baseline, 6 weeks, 12 weeks
Change in Body Mass Index (in Kilograms Per Square Meter)
Time Frame: Baseline, 6 weeks, 12 weeks
Height and weight will be measured by nurses at baseline, 6, and 12 weeks. Change will be calculated by subtracting the baseline value from the value at 6 and 12 weeks.
Baseline, 6 weeks, 12 weeks
Change in Waist Circumference (in Centimeters)
Time Frame: Baseline, 6 weeks, 12 weeks
Waist circumference will be measured by nurses at baseline, 6, and 12 weeks. Change will be calculated by subtracting the baseline value from the value at 6 and 12 weeks.
Baseline, 6 weeks, 12 weeks
Change in Systolic Blood Pressure (Millimeters of Mercury)
Time Frame: Baseline, 6 weeks, 12 weeks
Blood pressure will be measured by nurses at baseline, 6, and 12 weeks. Change will be calculated by subtracting the baseline value from the value at 6 and 12 weeks.
Baseline, 6 weeks, 12 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.
Massachusetts General Hospital

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: Jeff C Huffman, 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)

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.
September 16, 2021

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.
September 16, 2024

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.
September 16, 2024

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 13, 2021

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.
April 13, 2021

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.
April 19, 2021

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.
September 2, 2026

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.
August 11, 2026

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.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 2021P000881
  • P30AG048785 (U.S. NIH Grant/Contract)

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings