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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
116
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.
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.
Massachusetts General Hospital
Boston, Massachusetts, United States
Change in Moderate-Vigorous Physical Activity [MVPA]
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.
Time frame: Baseline, 6 weeks, 12 weeks
Proportion of Text Message Sessions Completed
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.
Time frame: Weekly over 12 weeks.
Mean Utility Ratings of Positive Psychology Text Messages
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.
Time frame: 6 weeks; 12 weeks
Mean Utility Ratings of Physical Activity Text Messages
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.
Time frame: 6 weeks; 12 weeks
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Mean Utility Ratings of Stress Reduction Text Messages
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.
Time frame: 6 weeks; 12 weeks
Mean Utility Ratings of Phone Check-ins
Participants will rate the utility of the phone sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful).
Time frame: 12 weeks
Change in Overall Physical Activity
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.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Sedentary Time
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.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Self-reported Physical Activity
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.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Positive Affect (Positive Affect Items of the Positive and Negative Affect Schedule [PANAS])
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.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Optimism (Life Orientation Test - Revised [LOT-R])
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.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Life Satisfaction (Satisfaction With Life Scale [SWLS])
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.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Depressive Symptoms (Hospital Anxiety and Depression Scale Depression Subscale [HADS-D])
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.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Anxiety (Hospital Anxiety and Depression Scale Anxiety Subscale [HADS-A])
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.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Exercise Self-efficacy (Self-efficacy for Exercise Scale [SES])
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.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Perceived Constraints (Perceived Constraints Subscale of the MIDUS Sense of Control Measure)
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.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Personal Mastery (Personal Mastery Subscale of the MIDUS Sense of Control Measure)
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.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Function (General Health Questionnaire-12 [GHQ-12])
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.
Time frame: 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])
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.
Time frame: 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])
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.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Body Weight
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.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Body Mass Index (in Kilograms Per Square Meter)
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.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Waist Circumference (in Centimeters)
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.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Systolic Blood Pressure (Millimeters of Mercury)
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.
Time frame: Baseline, 6 weeks, 12 weeks