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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG086637 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The goal of this clinical trial is to compare the effect of different types of text messages on physical activity levels of middle-aged and older adults and to determine whether these messages are effective in adults age 40 and older who are engaging in less than 90 minutes per week of moderate or higher intensity physical activity. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Validated library of text messages | Active Comparator | Participants in this arm will receive motivational text messages that have been written and used in previous studies. |
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| Newly created text messages | Experimental | Participants in this arm will receive motivational text messages that have not been used in previous studies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text Messaging Intervention | Behavioral | Participants will receive up to 4 motivational text messages per day during a self-selected 12-hour window. These messages focus on two content areas: 1) Move more, and 2) sit less. Delivery of these messages occurs in two phases:
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| Measure | Description | Time Frame |
|---|---|---|
| Daily Step Count | The primary outcome measure is the average daily step count, which is assessed using a blinded, research-grade activPAL activity monitor, worn on the thigh for a 7-day assessment period. | The activPAL is worn on the thigh for a 7-day assessment period before the intervention begins (baseline), after 3 months of intervention, and then again 3 months after the intervention is complete. The total time frame is 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanisms of Behavior Change for Adherence: Habit Strength | Habit Strength will be assessed using the Behavioral Automaticity Index from the Self-Report Habit Index to measure how automatic the exercise behavior has become. Scores are calculated as the average item responses and range from 1 to 7 with higher scores reflecting greater experienced automaticity (i.e., stronger habits). | These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ann M Mehringer | Contact | 734-647-6050 | amehring@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| David E Conroy, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
De-identified individual participant data (IPD) underlying the results reported in primary and secondary publications will be shared. This includes baseline behavioral metrics, coarsened demographics, post-intervention outcomes, and follow-up data. To protect participant privacy, all data will be stripped of direct identifiers, ages will be binned into 5-to-10-year bands, geographic markers restricted to broad regions, and timeline dates converted to "days since randomization." Raw, free-text qualitative journal entries will be suppressed entirely due to re-identification risks.
Data and supporting documentation will be made available concurrently with the primary peer-reviewed publication of the trial results and will remain accessible for 5 years post-publication. This immediate availability complies with the NIH Data Management and Sharing Policy.
Access is restricted to qualified external researchers affiliated with an accredited academic or non-profit research institution. Applicants must submit a formal, written research proposal detailing a sound scientific hypothesis and an analytical plan, alongside documentation of local IRB approval/waiver. Approved requestors and their sponsoring institutions must sign a legally binding Data Use Agreement (DUA) that strictly prohibits any re-identification or external data-linking attempts.
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Mechanisms of Behavior Change for Adherence: Exercise Identity (Reflective) | Exercise Identity will be assessed using the Exercise Identity Scale to see how much participants view themselves as "exercisers". Scores are based on the average item response and range from 1 to 7 with higher scores representing a stronger exercise identity. | These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6). |
| Mechanisms of Behavior Change for Adherence: Automatic Affective Evaluations | Automatic Affective Evaluations will be assessed using a Single-Category Implicit Association Test (SCIAT) to assess non-conscious attitudes toward physical activity. Scores are standardized mean differences of response times between blocks of trials where physical activity is paired with unpleasant attributes and blocks of trials where physical activity is paired with pleasant attributes. Higher scores indicate more favorable automatic affective evaluations of physical activity. | These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6). |
| Ambulatory Cognitive Function: Processing Speed | Processing Speed will be assessed with the Mobile Monitoring of Cognitive Change (M2C2) Symbol Search Task. Scores are based on response times for accurate trials so there is no fixed range for scores. Shorter response times indicate faster (better) processing speed; longer response times indicate slower (worse) processing speed. | These secondary outcomes are collected at the same major time points as the primary outcome: Baseline (month 0), post-intervention (month 3), and follow-up (6 month). |
| Ambulatory Cognitive Function: Working Memory Capacity | Working Memory Capacity will be measured using the M2C2 Grid Memory Task. Scores are based on response accuracy measured as a Euclidean distance score. Shorter distance scores indicate more working memory capacity; longer distance scores indicate less working memory capacity. | These secondary outcomes are collected at the same major time points as the primary outcome: Baseline (month 0), post-intervention (month 3), and follow-up (6 month). |