A Randomized Pilot Trial of a Multicomponent Interactive Text Message Intervention to Promote Physical Activity in Midlife Adults
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Middle Aged
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Change in Moderate-Vigorous Physical Activity [MVPA]
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
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.
Investigators
Jeff C. Huffman, MD
Director, Cardiac Psychiatry Research Program
Massachusetts General Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Proportion of text message sessions completed(Weekly over 12 weeks.)
- Mean utility ratings of positive psychology text messages(6 weeks; 12 weeks)
- Mean utility ratings of phone check-ins(6 weeks; 12 weeks)
- Change in optimism (Life Orientation Test - Revised [LOT-R])(Baseline, 6 weeks, 12 weeks)
- Change in life satisfaction (Satisfaction with Life Scale [SWLS])(Baseline, 6 weeks, 12 weeks)
- Change in function (General Health Questionnaire-12 [GHQ-12])(Baseline, 6 weeks, 12 weeks)
- Change in body weight(Baseline, 6 weeks, 12 weeks)
- Mean utility ratings of physical activity text messages(6 weeks; 12 weeks)
- Change in waist circumference (in centimeters)(Baseline, 6 weeks, 12 weeks)
- Mean utility ratings of stress reduction text messages(6 weeks; 12 weeks)
- Change in overall physical activity(Baseline, 6 weeks, 12 weeks)
- Change in sedentary leisure time(Baseline, 6 weeks, 12 weeks)
- Change in self-reported physical activity(Baseline, 6 weeks, 12 weeks)
- Change in positive affect (positive affect items of the Positive and Negative Affect Schedule [PANAS])(Baseline, 6 weeks, 12 weeks)
- Change in body mass index (in kilograms per square meter)(Baseline, 6 weeks, 12 weeks)
- Change in depressive symptoms (Hospital Anxiety and Depression Scale depression subscale [HADS-D])(Baseline, 6 weeks, 12 weeks)
- Change in perceived constraints (perceived constraints subscale of the MIDUS Sense of Control measure)(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])(Baseline, 6 weeks, 12 weeks)
- Change in anxiety (Hospital Anxiety and Depression Scale anxiety subscale [HADS-A])(Baseline, 6 weeks, 12 weeks)
- Change in exercise self-efficacy (Self-efficacy for Exercise Scale [SES])(Baseline, 6 weeks, 12 weeks)
- Change in social support (Norbeck Social Support Questionnaire)(Baseline, 6 weeks, 12 weeks)
- Change in personal mastery (personal mastery subscale of the MIDUS Sense of Control measure)(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])(Baseline, 6 weeks, 12 weeks)
- Change in blood pressure (millimeters of mercury)(Baseline, 6 weeks, 12 weeks)