- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04849052
Text Messaging to Increase Activity in Midlife (MASTERY)
September 11, 2023 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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
80
Phase
- 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
- Name: Jeff C Huffman, MD
- Phone Number: 617-724-2910
- Email: jhuffman@partners.org
Study Contact Backup
- Name: Christopher M Celano, MD
- Phone Number: 617-726-6485
- Email: ccelano@mgh.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Jeff C Huffman, MD
- Phone Number: 617-724-9142
- Email: jhuffman@mgh.harvard.edu
-
-
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
45 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Midlife status (age 45-64 at enrollment).
- 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:
- Existing coronary artery disease (CAD; diagnosed via cardiac catheterization using standard coronary artery stenosis definitions or prior ACS).
- 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).
- Participation in any other programs focused on cardiac prevention or well-being (e.g., cardiac rehabilitation).
- A cognitive disturbance precluding participation or informed consent, assessed using a six-item screen7 designed to assess suitability for research participation.
- Inability to speak/write fluently in English.
- 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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
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
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.
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Weekly over 12 weeks.
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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).
|
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).
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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).
|
6 weeks; 12 weeks
|
Mean utility ratings of phone check-ins
Time Frame: 6 weeks; 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).
|
6 weeks; 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 leisure 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 leisure time per day.
Participants will indicate which hours represent leisure time during workdays and off days/weekends to allow us to ascertain this outcome.
|
Baseline, 6 weeks, 12 weeks
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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.
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Baseline, 6 weeks, 12 weeks
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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
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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.
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Baseline, 6 weeks, 12 weeks
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Change in life satisfaction (Satisfaction with Life Scale [SWLS])
Time Frame: Baseline, 6 weeks, 12 weeks
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The Satisfaction with Life Scale is a 5-item scale designed to measure global cognitive judgments of one's life satisfaction (Range: 5-35).
Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks.
|
Baseline, 6 weeks, 12 weeks
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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.
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Baseline, 6 weeks, 12 weeks
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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.
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Baseline, 6 weeks, 12 weeks
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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
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Change in social support (Norbeck Social Support Questionnaire)
Time Frame: Baseline, 6 weeks, 12 weeks
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The Norbeck Social Support Questionnaire will be used to assess an individual's perceived emotional and tangible support.
Likert scale ratings for each person in the individual's social network will be made and the average across the social network will be calculated (Range:0-4).
Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks.
Higher scores indicate higher levels of perceived social support.
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Baseline, 6 weeks, 12 weeks
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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.
Higher scores indicate higher levels of perceived constraints.
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Baseline, 6 weeks, 12 weeks
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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 - perceived constraints (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 perceived constraints.
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Baseline, 6 weeks, 12 weeks
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Change in function (General Health Questionnaire-12 [GHQ-12])
Time Frame: Baseline, 6 weeks, 12 weeks
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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.
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Baseline, 6 weeks, 12 weeks
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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.
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Baseline, 6 weeks, 12 weeks
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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
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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.
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Baseline, 6 weeks, 12 weeks
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Change in body weight
Time Frame: Baseline, 6 weeks, 12 weeks
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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.
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Baseline, 6 weeks, 12 weeks
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Change in body mass index (in kilograms per square meter)
Time Frame: Baseline, 6 weeks, 12 weeks
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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.
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Baseline, 6 weeks, 12 weeks
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Change in waist circumference (in centimeters)
Time Frame: Baseline, 6 weeks, 12 weeks
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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.
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Baseline, 6 weeks, 12 weeks
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Change in 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.
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Baseline, 6 weeks, 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
September 16, 2021
Primary Completion (Estimated)
February 1, 2024
Study Completion (Estimated)
February 1, 2024
Study Registration Dates
First Submitted
April 13, 2021
First Submitted That Met QC Criteria
April 13, 2021
First Posted (Actual)
April 19, 2021
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 11, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2021P000881
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
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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