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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Middle Aged

Intervention / Treatment
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* Behavioral: Move with Meaning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, wait-list controlled, blinded intervention trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Move with Meaning<br>In Move with Meaning, participants will engage in twice weekly, interactive text message sessions, which are accompanied by audio content to promote engagement in the program. In the first session of each week, participants will review their physical activity goal and positive psychology topic from last week, then learn about a new positive psychology and physical activity topic and ultimately set a new physical activity goal for the week. In the second session, participants will either be reminded of the content of the audio file and the goal they set earlier that week. The program will run for eight weeks. | Behavioral: Move with Meaning<br>* 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.<br>|
| No Intervention: Wait-list control<br>Participants in the wait-list control condition will engage in usual medical care for eight weeks, then will complete the Move with Meaning program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of text message sessions successfully delivered | The automated platform will record rates of successful text message delivery. | Weekly over 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Text message, Podcast, Well-being, Physical activity