Clinical trial NCT04849052: Text Messaging to Increase Activity in Midlife
Official title: A Randomized Pilot Trial of a Multicomponent Interactive Text Message Intervention to Promote Physical Activity in Midlife Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Middle Aged
Keywords: Text Message
Physical Activity
Stress Reduction
Positive Psychology
Well-being
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 116
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, single-blinded study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Moderate-Vigorous Physical Activity [MVPA]
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Proportion of text message sessions completed
timeFrame: Weekly over 12 weeks.
measure: Mean utility ratings of positive psychology text messages
timeFrame: 6 weeks; 12 weeks
measure: Mean utility ratings of physical activity text messages
timeFrame: 6 weeks; 12 weeks
measure: Mean utility ratings of stress reduction text messages
timeFrame: 6 weeks; 12 weeks
measure: Mean utility ratings of phone check-ins
timeFrame: 6 weeks; 12 weeks
measure: Change in overall physical activity
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in sedentary leisure time
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in self-reported physical activity
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in positive affect (positive affect items of the Positive and Negative Affect Schedule [PANAS])
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in optimism (Life Orientation Test - Revised [LOT-R])
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in life satisfaction (Satisfaction with Life Scale [SWLS])
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in depressive symptoms (Hospital Anxiety and Depression Scale depression subscale [HADS-D])
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in anxiety (Hospital Anxiety and Depression Scale anxiety subscale [HADS-A])
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in exercise self-efficacy (Self-efficacy for Exercise Scale [SES])
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in social support (Norbeck Social Support Questionnaire)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in perceived constraints (perceived constraints subscale of the MIDUS Sense of Control measure)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in personal mastery (personal mastery subscale of the MIDUS Sense of Control measure)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in function (General Health Questionnaire-12 [GHQ-12])
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in mental health related quality of life (Medical Outcomes Study Short Form-12 mental component score [SF-12 MCS])
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in physical health related quality of life (Medical Outcomes Study Short Form-12 physical component score [SF-12 PCS])
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in body weight
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in body mass index (in kilograms per square meter)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in waist circumference (in centimeters)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in blood pressure (millimeters of mercury)
timeFrame: Baseline, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jeff C Huffman, MD
role: PRINCIPAL_INVESTIGATOR
References: