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This project is Project three of a four project Prevention Coaching Lab CREATE grant entitled "Transforming Prevention into Action" aimed at effectively engaging patients and their families to improve their health and medical care.
This project will test the feasibility and effectiveness of the prevention focused, internet mediated healthy lifestyle Stay Strong program tailored to the needs, preferences and demographics of OEF/OIF/OND Veterans.
Veterans from Afghanistan and Iraq (OEF/OIF/OND) are at high risk for becoming overweight and obese. However, existing VA programs are not designed for younger Veterans who are comfortable with technology-mediated interventions, may not yet have developed obesity-related illnesses, and contain a relatively high percentage of women compared to previous Veteran cohorts. Technology-mediated lifestyle interventions that include continuous, objective home monitoring of physical activity, automated internet mediated feedback, and e-coaching increase physical activity and improve weight loss in non-Veteran populations. When delivered on a large scale, such interventions represent low cost but effective alternatives to face-to-face lifestyle change interventions that can be implemented widely in the VA health care system. Thus, this project will test the feasibility and effectiveness of the prevention focused, internet-mediated healthy lifestyle physical activity program, Stay Strong w/coaching, tailored to the needs, preferences and demographics of OEF/OIF/OND Veterans. Specifically, Stay Strong w/coaching relies on use of a wearable device, the Fitbit Charge 2, and incorporates coaching support, tailored messages, and personalized physical activity goals. Stay Strong w/coaching will be compared to the use of the Fitbit Charge 2 with standard online support (Stay Strong).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stay Strong w/coaching | Experimental | participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support. |
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| Stay Strong | Active Comparator | participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stay Strong w/coaching | Behavioral | Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device | Physical activity is measured as Active Minutes by a wearable Fitbit Charge 2 device; daily activity is averaged over a one week period for which at least 5 days of valid data are available. | Change from Baseline in objectively monitored physical activity at one year after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight as Measured From VA Medical Record | Weights were extracted from VHA's Corporate Data Warehouse, vital signs package due to the high number of missing weights from the study provided blue tooth scale. | Change from Baseline in weight at one year after randomization |
| Change in Depression Score as Assessed by the Personal Health Questionnaire Depression Scale (PHQ-8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura J. Damschroder, MPH | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30694208 | Result | Buis LR, McCant FA, Gierisch JM, Bastian LA, Oddone EZ, Richardson CR, Kim HM, Evans R, Hooks G, Kadri R, White-Clark C, Damschroder LJ. Understanding the Effect of Adding Automated and Human Coaching to a Mobile Health Physical Activity App for Afghanistan and Iraq Veterans: Protocol for a Randomized Controlled Trial of the Stay Strong Intervention. JMIR Res Protoc. 2019 Jan 29;8(1):e12526. doi: 10.2196/12526. | |
| 32913914 |
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After consent and prior to randomization participants were to completed baseline survey, register app, and complete a baseline physical activity (PA) period for randomization. 56 participants were excluded due to failure to complete baseline survey or register app. 52 participants were excluded due to failure to provide baseline PA.
Letters were mailed to potential participants. They used the information in the recruitment letter to accessed an online portal and respond to screening question. If eligible, they completed the consent documentation, baseline questionnaire, downloaded and registered the Stay Strong App. Recruitment period was from 10/1/2017 - 4/30/2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stay Strong w/Coaching | Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support. Stay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program. |
| FG001 | Stay Strong | Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support. Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stay Strong w/Coaching | Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support. Stay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device | Physical activity is measured as Active Minutes by a wearable Fitbit Charge 2 device; daily activity is averaged over a one week period for which at least 5 days of valid data are available. | Population decreases with time, at 12-month follow-up: SS+coaching 68; SS 58. | Posted | Least Squares Mean | 95% Confidence Interval | Active minutes/week | Change from Baseline in objectively monitored physical activity at one year after randomization |
|
Through study completion, an average of 1 year.
Adverse event information was collected from participants if they reported events at quarterly status update. Adverse event information was also collected from patients through contact with coach interventionist or if patient reported during 6 or 12 month reminder calls for outcome survey. Adverse events were monitored/assessed without regard to the specific adverse event terms.
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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 | Stay Strong w/Coaching | Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support. Stay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Important Medical Event | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Issue with device connectivity leading to missing data. PA is focused on proprietary measure of Active Minutes and any potential changes to how it is calculated by Fitbit are out of our control. Pain and Depression are self-reported measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Damschroder | VA ORD | 734-845-3603 | laura.damschroder@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2018 | Nov 5, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| Stay Strong | Behavioral | Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device. |
|
The Personal Health Questionnaire Depression Scale (PHQ) will be administered via online survey. Personal Health Questionnaire (8 item version),Reporting Scores on a Scale Lower Scores Indicate a Better Outcome, Range: 0-24 |
| Change from Baseline Depression score at one year after randomization |
| Change in Pain Measures as Assessed by the VA Pain Intensity | Pain intensity will be elicited via online survey. Neuropathic Pain in Past Week Reporting Scores on a Scale, Lower Scores Indicate a Better Outcome, Range: 0-10 | Change from Baseline in Pain measures at one year after randomization |
| Derived |
| Olsen MK, Stechuchak KM, Hung A, Oddone EZ, Damschroder LJ, Edelman D, Maciejewski ML. A data-driven examination of which patients follow trial protocol. Contemp Clin Trials Commun. 2020 Aug 13;19:100631. doi: 10.1016/j.conctc.2020.100631. eCollection 2020 Sep. |
| 32687474 | Derived | Damschroder LJ, Buis LR, McCant FA, Kim HM, Evans R, Oddone EZ, Bastian LA, Hooks G, Kadri R, White-Clark C, Richardson CR, Gierisch JM. Effect of Adding Telephone-Based Brief Coaching to an mHealth App (Stay Strong) for Promoting Physical Activity Among Veterans: Randomized Controlled Trial. J Med Internet Res. 2020 Aug 4;22(8):e19216. doi: 10.2196/19216. |
| 30681965 | Derived | Buis LR, Dawood K, Kadri R, Dawood R, Richardson CR, Djuric Z, Sen A, Plegue M, Hutton D, Brody A, McNaughton CD, Brook RD, Levy P. Improving Blood Pressure Among African Americans With Hypertension Using a Mobile Health Approach (the MI-BP App): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 25;8(1):e12601. doi: 10.2196/12601. |
| Excluded |
|
| BG001 | Stay Strong | Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support. Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Fitbit-Captured Active Minutes/Week, Median | Median | Inter-Quartile Range | Active minutes/week |
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| Fitbit-captured steps/day, mean | Mean | Standard Deviation | Steps/day |
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| Depression scale (PHQ-8), Median | Lower Scores Indicate a Better Outcome, Range: 0-24 | Median | Inter-Quartile Range | units on a scale |
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| Pain Intensity >=4 | Count of Participants | Participants |
|
| PHQ-8 - Clinically Significant Depression | Count of Participants | Participants |
|
| OG001 | Stay Strong | Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support. Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device. |
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| Secondary | Change in Weight as Measured From VA Medical Record | Weights were extracted from VHA's Corporate Data Warehouse, vital signs package due to the high number of missing weights from the study provided blue tooth scale. | Due to missing data from study provided scale, EHR weight was pulled for all patients, however, roughly half of the population lacked EHR weights within the time-frame of the study. | Posted | Least Squares Mean | 95% Confidence Interval | weight by pounds | Change from Baseline in weight at one year after randomization |
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| Secondary | Change in Depression Score as Assessed by the Personal Health Questionnaire Depression Scale (PHQ-8) | The Personal Health Questionnaire Depression Scale (PHQ) will be administered via online survey. Personal Health Questionnaire (8 item version),Reporting Scores on a Scale Lower Scores Indicate a Better Outcome, Range: 0-24 | Population decreases with time, at 12-month follow-up: SS+coaching 96; SS 81. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline Depression score at one year after randomization |
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| Secondary | Change in Pain Measures as Assessed by the VA Pain Intensity | Pain intensity will be elicited via online survey. Neuropathic Pain in Past Week Reporting Scores on a Scale, Lower Scores Indicate a Better Outcome, Range: 0-10 | Population decreases with time, at 12-month follow-up: SS+coaching 101; SS 84. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Change from Baseline in Pain measures at one year after randomization |
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| 0 |
| 178 |
| 0 |
| 178 |
| 3 |
| 178 |
| EG001 | Stay Strong | Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support. Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device. | 0 | 179 | 0 | 179 | 1 | 179 |
| Important Medical Event | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Protocol Deviation | Investigations | Non-systematic Assessment |
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