A Text- and Audio-based Intervention to Promote Physical Activity in Midlife

Middle Aged Clinical Trial

Official title:

A Text- and Audio-based Intervention to Promote Physical Activity in Midlife

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06172933
• Other study ID #: 2023P003312
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Christopher M Celano, MD
• Phone: 617-726-6485
• Email: ccelano[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

Inclusion Criteria:

• Midlife adults (aged 45-64 years at the time of enrollment)

• Suboptimal physical activity (score < 6 on the Medical Outcomes Study Specific Adherence Scale physical activity item)

• 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

Related Conditions & MeSH terms

• Middle Aged

Intervention

Behavioral:
• Move with Meaning
Participants will engage in twice weekly text message sessions, will listen to a weekly audio session, and will work towards a physical activity goal each week, for a total of eight weeks.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of text message sessions successfully delivered	The automated platform will record rates of successful text message delivery.	Weekly over 8 weeks
Secondary	Proportion of audio sessions completed by participants	We will record the number of sessions in which participants engaged (e.g., responded to a text message), out of a total of 8 sessions.	Weekly over 8 weeks
Secondary	Session utility	Participants will rate the utility of each session, measured on a 10-point Likert scale. Higher scores indicate greater utility.	Weekly over 8 weeks
Secondary	Change in overall physical activity (in steps/day)	Physical activity (steps) will be measured via an Actigraph accelerometer. We will use established accelerometer protocols to measure the mean number of steps taken per day at each time point.	Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)
Secondary	Change in moderate to vigorous physical activity (MVPA; in mean minutes/day)	MVPA (reported in mean minutes of MVPA/day) will be measured via an Actigraph accelerometer and recorded in mean minutes/day.	Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)
Secondary	Change in sedentary time (in mean minutes/day)	Sedentary time (mean minutes/day) will be measured via Actigraph accelerometer.	Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)
Secondary	Change in self-reported physical activity (International Physical Activity Questionnaire [IPAQ]; in metabolic equivalent-minutes/week)	This will be measured via the International Physical Activity Questionnaire (IPAQ) as a secondary measure of physical activity.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Secondary	Change in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items)	Positive affect (our main psychological outcome given its links to health outcomes and sensitivity to change) will be assessed via the Positive and Negative Affect Schedule (PANAS) positive affect items. PANAS scores range from 10-50, with higher scores indicating higher levels of positive affect.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Secondary	Change in optimism (Life Orientation Test - Revised [LOT-R])	Optimism will be measured using the Life Orientation Test - Revised (LOT-R), a frequently used 6-item instrument that assesses dispositional optimism. LOT-R scores range from 0-24, with higher scores indicating higher levels of optimism.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Secondary	Change in depressive symptoms (depression subscale of the Hospital Anxiety and Depression Scale [HADS]).	Depressive symptoms will be measured using the 7-item depression subscale of the Hospital Anxiety and Depression Scale (HADS). The depression subscale of the HADS ranges from 0-21, with higher scores indicating higher levels of depression.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Secondary	Change in anxiety (anxiety subscale of the Hospital Anxiety and Depression Scale [HADS])	Anxiety will be measured using the 7-item anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). The anxiety subscale of the HADS ranges from 0-21, with higher scores indicating higher levels of anxiety.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Secondary	Change in exercise self-efficacy (Self-Efficacy for Exercise scale [SEE])	Exercise self-efficacy will be measured via the Self-Efficacy for Exercise (SEE) scale. SEE scores range from 0-90, with higher scores indicating higher levels of self-efficacy for exercise.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Secondary	Change in perceived social support (Multidimensional Scale of Perceived Social Support)	Perceived social support will be measured by the Multidimensional Scale of Perceived Social Support (MSPSS). MSPSS scores range from 1-7, with higher scores indicating higher levels of perceived social support.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Secondary	Change in internal health locus of control (Multidimensional Health Locus of Control [MHLC] scale)	Internal locus/sense of control will be measured using the Multidimensional Health Locus of Control (MHLC) scale. The internal locus of control score from the MHLC ranges from 6-36, with higher scores indicating greater internal locus of control.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Secondary	Change in positive affect during activity (Physical Activity Enjoyment Scale)	Positive affect during activity will be measured using the Physical Activity Enjoyment Scale. Physical Activity Enjoyment Scale scores range from 18-126, with higher scores indicating higher levels of enjoyment during activity.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)