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| ID | Type | Description | Link |
|---|---|---|---|
| PEC 15-470 | Other Grant/Funding Number | Office of Connected Care |
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This was a pilot evaluation conducted to test procedures for a possible future trial and provide preliminary insights regarding whether text messages sent to Veterans could help support nutrition and/or physical activity health goals. For the purposes of the pilot, the goal was to enroll one participant.
The investigators prepared procedures for a one-group pilot intended to evaluate the delivery of automated text messages to Veterans. Completion of this pilot will provide preliminary insights regarding the delivering automated text messages focused on nutrition and/or physical activity health goals, and potential impacts on outcomes like self-efficacy, goal commitment, and health confidence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text message | Experimental | Participants receive text messages about healthy eating or physical activity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text message | Behavioral | Two months of daily text messages to support meeting a health goal |
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| Measure | Description | Time Frame |
|---|---|---|
| Self-efficacy: Healthful Eating Via Revised Eating Self-Efficacy Scale (ESES-R) | Self-reported confidence in performing healthful diet and physical activity behaviors. Self-efficacy - Healthful eating via Revised Eating Self-Efficacy Scale (ESES-R). Range: 1-10; higher values represent a better outcome. | Change from Baseline to 2 months |
| Goal Commitment: Healthful Eating Via the Hollenbeck, Williams, and Klein Goal Commitment Scale | Self-reported commitment to healthful diet and physical activity goals. Goal commitment - Healthful eating via the Hollenbeck, Williams, and Klein Goal Commitment Scale. Range: 1-5; higher values represent a better outcome. | Change from Baseline to 2 months |
| Self-efficacy: Physical Activity Via the Self-efficacy for Exercise Behaviors Scale | Self-reported confidence in performing healthful diet and physical activity behaviors. Self-efficacy - Physical activity via the Self-efficacy for Exercise Behaviors Scale. Range: 1-5; higher values represent a better outcome. | Change from Baseline to 2 months |
| Goal Commitment - Physical Activity Via the Hollenbeck, Williams, and Klein Physical Activity Scale | Self-reported commitment to healthful diet and physical activity goals. The determination to attempt a physical activity-related goal and consistently pursue it over time. Goal commitment - Physical activity via the Hollenbeck, Williams, and Klein Goal Commitment Scale. Range: 1-5; higher values represent a better outcome. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Health Confidence: the Health Confidence Score | Self-reported confidence in patient engagement. Health Confidence. Range: 0-12; higher values represent a better outcome. | Change from Baseline to 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Patrick Hogan, PhD MS BS | VA Bedford HealthCare System, Bedford, MA | Principal Investigator |
| Lisa M. Quintiliani, PhD | VA Bedford HealthCare System, Bedford, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Bedford HealthCare System, Bedford, MA | Bedford | Massachusetts | 01730 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Text Message | Participants receive text messages about healthy eating or physical activity. Text message: Two months of daily text messages to support meeting a health goal |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Text Message | Participants receive text messages about healthy eating or physical activity. Text message: Two months of daily text messages to support meeting a health goal |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Self-efficacy: Healthful Eating Via Revised Eating Self-Efficacy Scale (ESES-R) | Self-reported confidence in performing healthful diet and physical activity behaviors. Self-efficacy - Healthful eating via Revised Eating Self-Efficacy Scale (ESES-R). Range: 1-10; higher values represent a better outcome. | Posted | Number | score on a scale | Change from Baseline to 2 months |
|
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Data were collected over the course of 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Text Message | Participants receive text messages about healthy eating or physical activity. Text message: Two months of daily text messages to support meeting a health goal |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy P. Hogan | VA Bedford Healthcare System | 781-687-3181 | timothy.hogan@va.gov |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 2, 2024 | Apr 2, 2024 | Prot_000.pdf |
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One-group trial
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Goal Commitment: Healthful Eating Via the Hollenbeck, Williams, and Klein Goal Commitment Scale | Self-reported commitment to healthful diet and physical activity goals. Goal commitment - Healthful eating via the Hollenbeck, Williams, and Klein Goal Commitment Scale. Range: 1-5; higher values represent a better outcome. | Posted | Number | score on a scale | Change from Baseline to 2 months |
|
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| Primary | Self-efficacy: Physical Activity Via the Self-efficacy for Exercise Behaviors Scale | Self-reported confidence in performing healthful diet and physical activity behaviors. Self-efficacy - Physical activity via the Self-efficacy for Exercise Behaviors Scale. Range: 1-5; higher values represent a better outcome. | Posted | Number | score on a scale | Change from Baseline to 2 months |
|
|
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| Primary | Goal Commitment - Physical Activity Via the Hollenbeck, Williams, and Klein Physical Activity Scale | Self-reported commitment to healthful diet and physical activity goals. The determination to attempt a physical activity-related goal and consistently pursue it over time. Goal commitment - Physical activity via the Hollenbeck, Williams, and Klein Goal Commitment Scale. Range: 1-5; higher values represent a better outcome. | This scale was not administered at 2 month follow-up | Posted | Number | score on a scale | Baseline |
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| Secondary | Health Confidence: the Health Confidence Score | Self-reported confidence in patient engagement. Health Confidence. Range: 0-12; higher values represent a better outcome. | Posted | Number | score on a scale | Change from Baseline to 2 months |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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