Clinical trial NCT06172933: A Text- and Audio-based Intervention to Promote Physical Activity in Midlife
Official title: A Text- and Audio-based Intervention to Promote Physical Activity in Midlife
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Middle Aged
Keywords: Text message
Podcast
Well-being
Physical activity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, wait-list controlled, blinded intervention trial
Primary purpose: PREVENTION

Brief summary: This is a randomized, controlled pilot trial (N=30) to examine the feasibility, acceptability, and preliminary efficacy of the Move with Meaning program, an 8- week, text message- and audio-based intervention to promote physical activity in midlife adults.

Detailed description: This is a randomized, controlled pilot trial to examine the feasibility, acceptability, and preliminary efficacy of the Move with Meaning program, an 8- week, text message- and audio-based intervention to promote physical activity in midlife adults. In Move with Meaning, participants will listen to weekly audio sessions and complete twice weekly text message sessions, in which they will set a weekly physical activity goal. The primary outcome is feasibility (measured by number of successful text message sessions sent). Secondary outcomes include acceptability and preliminary impact on physical activity, psychological health-, and physical health-related outcomes.

Eligibility criteria: Inclusion Criteria:

* Midlife adults (aged 45-64 years at the time of enrollment)
* Suboptimal physical activity (\<150 minutes of moderate to vigorous physical activity, measured by accelerometer)
* Access to a phone capable of receiving text messages and listening to audio files (i.e., a smartphone)

Exclusion Criteria:

* An unrelated condition limiting physical activity
* Participation in any other programs focused on cardiac prevention or well-being
* A cognitive disturbance precluding participation or informed consent
* Current pregnancy
* Inability to speak/write fluently in English

Primary outcomes:
measure: Proportion of text message sessions successfully delivered
timeFrame: Weekly over 8 weeks
Secondary outcomes:
measure: Proportion of audio sessions completed by participants
timeFrame: Weekly over 8 weeks
measure: Session utility
timeFrame: Weekly over 8 weeks
measure: Change in overall physical activity (in steps/day)
timeFrame: Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)
measure: Change in moderate to vigorous physical activity (MVPA; in mean minutes/day)
timeFrame: Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)
measure: Change in sedentary time (in mean minutes/day)
timeFrame: Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)
measure: Change in self-reported physical activity (International Physical Activity Questionnaire [IPAQ]; in metabolic equivalent-minutes/week)
timeFrame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
measure: Change in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items)
timeFrame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
measure: Change in optimism (Life Orientation Test - Revised [LOT-R])
timeFrame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
measure: Change in depressive symptoms (depression subscale of the Hospital Anxiety and Depression Scale [HADS]).
timeFrame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
measure: Change in anxiety (anxiety subscale of the Hospital Anxiety and Depression Scale [HADS])
timeFrame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
measure: Change in exercise self-efficacy (Self-Efficacy for Exercise scale [SEE])
timeFrame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
measure: Change in perceived social support (Multidimensional Scale of Perceived Social Support)
timeFrame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
measure: Change in internal health locus of control (Multidimensional Health Locus of Control [MHLC] scale)
timeFrame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
measure: Change in positive affect during activity (Physical Activity Enjoyment Scale)
timeFrame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christopher M Celano, MD
role: PRINCIPAL_INVESTIGATOR
References: