Middle AgedMASTERYNCT04745182
A Tailored Program to Promote Well-being and Physical Activity in Mid-life Adults With Low Physical Activity
A study testing MASTERY in people with Middle Aged and Exercise, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a single-arm pilot trial to examine the feasibility, acceptability, and preliminary efficacy of the 12-week, phone-delivered, Midlife Activity, Stress reduction, Time Efficiency, Resilience, and Youthfulness (MASTERY) intervention, which utilizes positive psychology (PP), motivational interviewing (MI), and… Read more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Middle Aged, Exercise
- What is being tested?
- MASTERY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 19 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 45-64 years at time of enrollment.
- Low physical activity (defined as ≤150 minutes/week of MVPA, in accordance with consensus recommendations for moderate or greater intensity aerobic physical activity and measured using a brief version of the well-validated International Physical Activity Questionnaire (IPAQ) scale.
Who cannot join
- Existing coronary artery disease. Coronary artery disease will be identified through review of the medical record, with clarification by participants' primary clinician if needed, as part of recruitment procedures. Existing coronary artery disease will be defined as a prior acute coronary syndrome (unstable angina or myocardial infarction) or diagnosed via cardiac catheterization.
- To meet criteria for a prior acute coronary syndrome, for myocardial infarction, patients must have experienced at least two of three World Health Organization criteria for an acute myocardial infarction: typical chest pain, elevated cardiac enzymes, and electrocardiographic changes consistent with myocardial infarction.
- For unstable angina, participants must have had new onset angina within 2 months, exacerbation of previous angina with rest pain or with minimal exercise, or angina within 2 weeks of myocardial infarction, with confirmation of this diagnosis by the patient's primary medical provider or inpatient treatment team; this definition has been used in prior trials.
- To meet criteria for coronary artery disease diagnosed at cardiac catheterization, participants must have had 50% stenosis of the left main artery or 70% stenosis of another coronary artery, consistent with consensus definitions of obstructive coronary artery disease.
- Cognitive disturbance precluding participation or informed consent, as identified using a six-item cognitive screen designed to assess suitability for research participation.
- Lack of available telephone.
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- An inability to communicate in English.
- A condition limiting physical activity (e.g., arthritis, chronic obstructive pulmonary disease), identified by patient and medical record, confirmed by primary medical provider as needed.
- Participation in similar programs (e.g., mind-body interventions) as reported by patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This is a single-arm pilot trial to examine the feasibility, acceptability, and preliminary efficacy of the 12-week, phone-delivered, Midlife Activity, Stress reduction, Time Efficiency, Resilience, and Youthfulness (MASTERY) intervention, which utilizes positive psychology (PP), motivational interviewing (MI), and specific midlife modules (e.g., on time management, financial stress, caregiving stress, or occupational stress) to promote well-being and physical activity in mid-life adults.
Read the detailed description
This is a single-arm proof-of-concept trial of a phone-delivered positive psychology-motivational interviewing (PP-MI) intervention, with content adapted to midlife persons. Midlife adults with low physical activity were recruited from outpatient clinics, completed baseline outcome measures (including wearing an accelerometer to measure activity for one week), completed the 12-week MASTERY intervention, and then completed a follow-up session to obtain repeat outcome information. The intervention, which involved weekly phone sessions with a trained study team member, included the completion of PP exercises, setting physical activity goals, and completion of activities to reduce midlife-specific stressors. The primary outcomes were feasibility and acceptability, and secondary outcomes included accelerometer-measured physical activity and self-report outcomes.
- Conditions
- Middle Aged, Exercise
- Being tested
- MASTERY
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MASTERYBehavioural
A 12-week, phone-delivered intervention utilizing positive psychology (PP), motivational interviewing (MI), and specific midlife modules (e.g., on time management, financial stress, caregiving stress, or occupational stress) to promote physical activity and well-being in mid-life adults.
| Study group | Role | What they receive |
|---|---|---|
| MASTERY | Experimental | For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and will contain space to write a specific physical activity goal and to track physical activity (e.g., through step counter data) over the subsequent week. At the in-person visit #2, interventionists will explain PP exercise 1 and MI session 1 to the participants. Calls will last ~30 minutes. Participants will then independently complete PP exercises and MI-based goals and review them at phone sessions over 12 weeks. PP and MI components will be delivered stepwise within sessions (rather than intertwined) based on our experience, participant feedback, and pilot work. Receives: Behavioral: MASTERY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of total phone sessions completed
To assess the feasibility of the intervention
Measured: 12 weeks
Mean ease ratings of exercises
To assess how easy participants found the assigned exercises. Ratings will be made on a scale of 0-10, with 0 being very difficult and 10 being very easy.
Measured: 12 weeks
Mean utility ratings of exercises
To assess how useful participants found the assigned exercises. Ratings will be made on a scale of 0-10, with 0 being not at all useful and 10 being very useful.
Measured: 12 weeks
Secondary outcomes (6)
Proportion of sessions completed by participants
To assess the feasibility of study procedures. We will divide the number of phone sessions completed by participants by the total number of phone sessions that could have been completed.
Measured: 12 weeks
Change in Moderate-Vigorous Physical Activity
ActiGraph GT3X+ step counters 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 and at 12 weeks. We will report change from baseline to 12 weeks in the average number of minutes of MVPA performed per day.
Measured: Change from Baseline to 12 weeks
Change in Positive Affect
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 12 weeks. Higher scores indicate higher levels of positive affect.
Measured: Change in score from Baseline to 12 weeks
Change in Optimism
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 12 weeks. Higher scores indicate higher levels of optimism.
Measured: Change in score from Baseline to 12 weeks
Change in Depression
The Hospital Anxiety and Depression Scale (HADS)-depression 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 12 weeks. Higher scores indicate higher levels of depression.
Measured: Change in score from Baseline to 12 weeks
Change in Anxiety
The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure anxiety. 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 12 weeks. Higher scores indicate higher levels of anxiety.
Measured: Change in score from Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Oct 2019
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Middle AgedStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants were in the same group and received the same intervention.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff C. Huffman, MD, Massachusetts General Hospital
- Investigators
- Jeff C Huffman, MD, Study director, Massachusetts General Hopsital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745182
- Sponsor's protocol ID
- 2019P002328
- Acronym
- MASTERY
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huffman JC, Massey CN, Chung WJ, Harnedy LE, Carrillo A, Feig EH, Celano CM. A Psychological-Behavioral Intervention to Improve Physical Activity in Midlife Adults With Low Baseline Physical Activity. Prim Care Companion CNS Disord. 2021 Jul 29;23(4):20m02876. doi: 10.4088/PCC.20m02876.
PubMed 34324798
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tailored Program to Promote Well-being and Physical Activity in Mid-life Adults With Low Physical Activity
- ClinicalTrials.gov ID
- NCT04745182
- Acronym / sponsor ID
- MASTERY / 2019P002328
- Conditions
- Middle Aged, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm pilot trial to examine the feasibility, acceptability, and preliminary efficacy of the 12-week, phone-delivered, Midlife Activity, Stress reduction, Time Efficiency, Resilience, and Youthfulness (MASTERY) intervention, which utilizes positive psychology (PP), motivational interviewing (MI), and specific midlife modules (e.g., on time management, financial stress, caregiving stress, or occupational stress) to promote well-being and physical activity in mid-life adults.
Detailed description
This is a single-arm proof-of-concept trial of a phone-delivered positive psychology-motivational interviewing (PP-MI) intervention, with content adapted to midlife persons. Midlife adults with low physical activity were recruited from outpatient clinics, completed baseline outcome measures (including wearing an accelerometer to measure activity for one week), completed the 12-week MASTERY intervention, and then completed a follow-up session to obtain repeat outcome information. The intervention, which involved weekly phone sessions with a trained study team member, included the completion of PP exercises, setting physical activity goals, and completion of activities to reduce midlife-specific stressors. The primary outcomes were feasibility and acceptability, and secondary outcomes included accelerometer-measured physical activity and self-report outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants were in the same group and received the same intervention.
| Arm | Type | Receives |
|---|---|---|
| MASTERY | Experimental | Behavioral: MASTERYFor each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and will contain space to write a specific physical activity goal and to track physical activity (e.g., through step counter data) over the subsequent week. At the in-person visit #2, interventionists will explain PP exercise 1 and MI session 1 to the participants. Calls will last ~30 minutes. Participants will then independently complete PP exercises and MI-based goals and review them at phone sessions over 12 weeks. PP and MI components will be delivered stepwise within sessions (rather than intertwined) based on our experience, participant feedback, and pilot work. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 45-64 years at time of enrollment.
- Low physical activity (defined as ≤150 minutes/week of MVPA, in accordance with consensus recommendations for moderate or greater intensity aerobic physical activity and measured using a brief version of the well-validated International Physical Activity Questionnaire (IPAQ) scale.
Key exclusion criteria (9 listed)
- Existing coronary artery disease. Coronary artery disease will be identified through review of the medical record, with clarification by participants' primary clinician if needed, as part of recruitment procedures. Existing coronary artery disease will be defined as a prior acute coronary syndrome (unstable angina or myocardial infarction) or diagnosed via cardiac catheterization.
- To meet criteria for a prior acute coronary syndrome, for myocardial infarction, patients must have experienced at least two of three World Health Organization criteria for an acute myocardial infarction: typical chest pain, elevated cardiac enzymes, and electrocardiographic changes consistent with myocardial infarction.
- For unstable angina, participants must have had new onset angina within 2 months, exacerbation of previous angina with rest pain or with minimal exercise, or angina within 2 weeks of myocardial infarction, with confirmation of this diagnosis by the patient's primary medical provider or inpatient treatment team; this definition has been used in prior trials.
- To meet criteria for coronary artery disease diagnosed at cardiac catheterization, participants must have had 50% stenosis of the left main artery or 70% stenosis of another coronary artery, consistent with consensus definitions of obstructive coronary artery disease.
- Cognitive disturbance precluding participation or informed consent, as identified using a six-item cognitive screen designed to assess suitability for research participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MASTERYA 12-week, phone-delivered intervention utilizing positive psychology (PP), motivational interviewing (MI), and specific midlife modules (e.g., on time management, financial stress, caregiving stress, or occupational stress) to promote physical activity and well-being in mid-life adults. | Behavioural | MASTERY |
Primary outcome
Proportion of total phone sessions completed
Time frame: 12 weeks
To assess the feasibility of the intervention
Mean ease ratings of exercises
Time frame: 12 weeks
To assess how easy participants found the assigned exercises. Ratings will be made on a scale of 0-10, with 0 being very difficult and 10 being very easy.
Mean utility ratings of exercises
Time frame: 12 weeks
To assess how useful participants found the assigned exercises. Ratings will be made on a scale of 0-10, with 0 being not at all useful and 10 being very useful.
6 secondary outcomes
Proportion of sessions completed by participants
Time frame: 12 weeks
Change in Moderate-Vigorous Physical Activity
Time frame: Change from Baseline to 12 weeks
Change in Positive Affect
Time frame: Change in score from Baseline to 12 weeks
Change in Optimism
Time frame: Change in score from Baseline to 12 weeks
Change in Depression
Time frame: Change in score from Baseline to 12 weeks
Change in Anxiety
Time frame: Change in score from Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Derived from this study: PubMed 34324798Huffman JC, Massey CN, Chung WJ, Harnedy LE, Carrillo A, Feig EH, Celano CM. A Psychological-Behavioral Intervention to Improve Physical Activity in Midlife Adults With Low Baseline Physical Activity. Prim Care Companion CNS Disord. 2021 Jul 29;23(4):20m02876. doi: 10.4088/PCC.20m02876.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff C Huffman, MD study director
Massachusetts General Hopsital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MASTERY in people with Middle Aged and Exercise, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of total phone sessions completed (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04745182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.