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| ID | Type | Description | Link |
|---|---|---|---|
| R33HL164868 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The goal of this clinical trial is to test a precision (person-specific and context-sensitive) messaging algorithm for increasing physical activity and slowing weight gain in insufficiently-active young adults. The main questions it aims to answer are:
Participants will be provided with education about health-enhancing physical activity and given an activity tracker to wear for 12 months. They will then be randomly assigned to one of three groups. Participants in one group (Precision AIM) will receive up to 4 messages/day selected and timed based on a person-specific algorithm that forecasts possible message effects periodically throughout the day. Messages will be drawn from one of three content libraries: move more, sit less, or inspirational quotes. Participants in a second group (Random AIM) will receive 4 messages/day selected at random from the same three content libraries and delivered at random times within their availability window. Participants in the third group (No AIM) will receive not motivational messages but will randomly assigned to the Random AIM group will receive up to 4 messages/day drawn at random from three content libraries at randomly-selected times. Step counts and weight will be assessed at baseline, and at 3 months, 6 months, 12 months, and 18 months. Researchers will compare Precision AIM, Random AIM and No AIM groups to see if physical activity increased more and weight gain was slower in Precision AIM than Random AIM or No AIM after 3, 6, and 12 months of intervention, and 6 months after the intervention is complete (18 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precision AIM | Experimental | Education + activity monitor + up to 4 text messages/day, each drawn from one of 3 content libraries and timed based on a person- and context-specific algorithm that will be updated monthly based on incoming data (within a participant-defined availability window) |
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| Random AIM | Active Comparator | Education + activity monitor + up to 4 text messages/day, each drawn from one of 3 content libraries and timed at random (within a participant-defined availability window). |
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| No AIM | Active Comparator | Education + activity monitor |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education | Behavioral | Education about health benefits of physical activity, 2018 US Physical Activity Guidelines, assigned goals tailored to baseline step counts, and worksheet to develop action and coping plans (three of each) |
| Measure | Description | Time Frame |
|---|---|---|
| Average daily step counts (6 months) | Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period | Change from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Average daily step counts (12 months) | Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period | Change from baseline to 12 months |
| Average daily step counts (18 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David E Conroy, PhD | University of Michigan | Principal Investigator |
| Constantino M Lagoa, PhD | The Pennsylvania State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States | ||
| The Pennsylvania State University |
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| Activity tracker | Behavioral | Fitbit activity tracker and mobile app to provide ad libitum behavioral feedback and self-regulatory support |
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| Text messaging (random timing and selection) | Behavioral | Four text messages/day at random times within a participant's availability window and drawn at random from one of three content libraries (move more [40%], sit less [40%], inspirational quotes [20%]) |
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| Text messaging (precision dosing) | Behavioral | Up to four text messages/day within a participant's availability window, timed and selected from one of three content libraries (move more, sit less, inspirational quotes) based on a person-specific dynamic model and contextual data |
|
Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period
| Change from 12 months to 18 months |
| Weight (6 months) | Weight (kg) measured by BodyTrace scale | Change from baseline to 6 months |
| Weight (12 months) | Weight (kg) measured by BodyTrace scale | Change from baseline to 12 months |
| Weight (18 months) | Weight (kg) measured by BodyTrace scale | Change from 12 months to 18 months |
| Moderate-to-vigorous intensity physical activity duration (6 months) | Average duration of daily moderate (or higher) physical activity recorded by Actigraph accelerometer over a 7-day monitoring period | Change from baseline to 6 months |
| Moderate-to-vigorous intensity physical activity duration (12 months) | Average duration of daily moderate (or higher) physical activity recorded by Actigraph accelerometer over a 7-day monitoring period | Change from baseline to 12 months |
| Moderate-to-vigorous intensity physical activity duration (18 months) | Average duration of daily moderate (or higher) physical activity recorded by Actigraph accelerometer over a 7-day monitoring period | Change from 12 months to 18 months |
| Light intensity physical activity duration (6 months) | Average duration of daily light-intensity physical activity recorded by Actigraph accelerometer over a 7-day monitoring period | Change from baseline to 6 months |
| Light intensity physical activity duration (12 months) | Average duration of daily light-intensity physical activity recorded by Actigraph accelerometer over a 7-day monitoring period | Change from baseline to 12 months |
| Light intensity physical activity duration (18 months) | Average duration of daily light-intensity physical activity recorded by Actigraph accelerometer over a 7-day monitoring period | Change from 12 months to 18 months |
| Sedentary behavior duration (6 months) | Average duration of daily sedentary behavior physical activity recorded by Actigraph accelerometer over a 7-day monitoring period | Change from baseline to 6 months |
| Sedentary behavior duration (12 months) | Average duration of daily sedentary behavior recorded by Actigraph accelerometer over a 7-day monitoring period | Change from baseline to 12 months |
| Sedentary behavior duration (18 months) | Average duration of daily sedentary behavior recorded by Actigraph accelerometer over a 7-day monitoring period | Change from 12 months to 18 months |
| University Park |
| Pennsylvania |
| 16802 |
| United States |
| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| D000072936 | Fitness Trackers |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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