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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01HL151668-01 | 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 main aim of this effort is to test a physical activity intervention, for adult clinical care patients at risk of developing cardiovascular disease. The intervention includes social-cognitive theory-based sessions, remote coaching, a body worn physical activity tracker (PAT), and is delivered online over one year. The investigators hypothesis that this intervention will be more successful at increasing physical activity (defined as objectively measured step counts and % of individuals meeting the moderate-vigorous physical activity goal) as an active control group who receives a body worn PAT and information on the CDC activity recommendations. The proposed intervention will be aligned with efforts by the US Centers for Disease Control to increase population physical activity levels and the American College of Sports Medicine (ACSM) to increase physical activity prescription in primary care.
The main aim of this effort is to test a physical activity intervention, for adult clinical care patients at risk of developing cardiovascular disease. The intervention includes 13 weekly and 6 monthly social-cognitive theory-based sessions, remote coaching, a body worn physical activity tracker (PAT), and is delivered online over one year.
A total of n=54 Clinical care patients aged 40-70 years of age with low physical activity (PA) levels (<150 minutes/week) at risk for cardiovascular disease will be recruited. Study outcomes will be measured at baseline, 6 months after intervention start and 12 months after intervention start.
For the primary outcomes, the investigators hypothesize that participants randomized to ActiveGOALSv2 + PAT will have significantly larger (a) increases in step counts/day and % meeting moderate-vigorous physical activity goal of 150 minutes/week (to 12 months) compared to the active PAT control group. Descriptive analyses and graphic displays will be used to identify outliers, missing data, and pattern of attrition. To ensure rigor, the primary analytic strategy will be a linear or generalized mixed-effect models approach in which treatment group, time, and time by group interaction are treated as fixed effects, and subject is treated as a random effect to account for individual subject variability (two sided hypothesis test; .05 level). Mixed models are applicable to longitudinal datasets that contain missing observations, (assuming data is missing at random). Regression modeling will be conducted to adjust for important covariates. The investigators will perform similar analyses to examine changes in secondary outcomes. Descriptive statistics on patient experience, beliefs/attitudes related to maintenance of physical activity changes, and program cost will also be reported.
Power and sample size: For a 2 sided test with alpha level set at .05, and assuming 20% attrition at 12 months, the investigators plan to recruit 54 participants to identify clinically relevant mean difference between randomized groups at 12-months of 2000 steps/day (with a power of .80), and 35% meeting MVPA goal (with a power of .80), given reference mean (sd) values were calculated from baseline waist worn accelerometer data from the current K12 of: 5250 (2200) steps/ day and the investigators assume 5% meeting goal at baseline in the control group.
Descriptive statistics will be used to describe the total eligible population, those referred, and those referred who participated in the study; in order to determine program reach. Exploratory Analysis of Important Pre-Existing Factors: Factor analysis will be used to identify importance of factors related to physical activity levels/ activity goal achievement over the 12 month follow-up (Mplus) from participant EHR data collected prior to intervention start. Factor structures of how individual factors contribute to activity outcomes will be explored at each time point. The best factor structure will be determined with Eigenvalues and fit indices (RMSEA, CFI, and TLI). Factor structures at the 2 time points will be compared at three levels to establish measurement invariance: 1) Configural equivalence, number of factors/ pattern of factor-indicator relationships are identical over time; 2) Metric equivalence, factor loadings are equal over time; and 3) Scalar equivalence, means and values are equivalent over time. Finally, the investigators will use descriptive statistics to report presence/absence of data on physical activity levels, cardiometabolic, and patient-centered outcomes in the EHR. The investigators will apply the same regression approaches utilized in Aim 1a to determine differences between randomized groups for EHR reported outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAT (Physical activity monitor) | Active Comparator | Participants will receive a physical activity tracker and encouragement to increase physical activity. |
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| ActiveGOALSv2 | Experimental | Participants will receive the ActiveGOALS online program with an integrated activity tracker. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ActiveGOALSv2 | Behavioral | 13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Meeting the Aerobic Activity Goal at 12 Months | Change between 0 and 12 months for y/n meeting the 150 minute/week moderate-vigorous activity goal based on minutes of activity from accelerometer | 12 months versus baseline |
| Change From Baseline in Step Counts at 12 Months | Objectively measured change in step counts between 0 and 12 months using ActiGraph accelerometer | 12 months versus baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Sedentary Behavior Minutes Over All Timepoints for 12 Months | Objectively measured sedentary behavior at each timepoint using ActiGraph accelerometer worn for 1 week, data for a given timepoint was averaged using only valid days during that week to assess average minutes/day. Valid days are days the monitor was worn for 10 or more hours. | baseline, 6 and 12 months |
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Inclusion Criteria:
Age 40-70 years of age
Low physical activity (PA) levels (<150 minutes/week)
At least one of the following common cardiometabolic risk factors:
Have access to the internet
Able to read English at a 6th grade level
Have primary care provider (PCP) permission to increase physical activity without supervision.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonny Rockette-Wagner, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
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Participants were requirement to complete baseline measures for the primary outcome using accelerometer. Participants who withdrew, were found to not be meeting eligibility criteria, or did not completing the measure after consenting were not randomized and were administratively withdrawn.
Participants enrolled between March 2022 and June 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | PAT (Physical Activity Monitor) | Participants will receive a physical activity tracker and encouragement to increase physical activity. PAT: Participants will receive a physical activity tracker and encouragement to increase activity. |
| FG001 | ActiveGOALSv2 | Participants will receive the ActiveGOALS online program with an integrated activity tracker. ActiveGOALSv2: 13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PAT (Physical Activity Monitor) | Participants will receive a physical activity tracker and encouragement to increase physical activity. PAT: Participants will receive a physical activity tracker and encouragement to increase activity. |
| BG001 | ActiveGOALSv2 |
| 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, 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 From Baseline in Meeting the Aerobic Activity Goal at 12 Months | Change between 0 and 12 months for y/n meeting the 150 minute/week moderate-vigorous activity goal based on minutes of activity from accelerometer | Due to participant drop out, incomplete monitor data at 12 months and loss to follow-up there were less people at the 12 month visit with valid monitor data | Posted | Dec 2025 | Count of Participants | Participants | 12 months versus baseline |
|
From enrollment to end of follow-up, 12 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 | PAT (Physical Activity Monitor) | Participants will receive a physical activity tracker and encouragement to increase physical activity. PAT: Participants will receive a physical activity tracker and encouragement to increase activity. |
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This was a small pilot study that was not powered to assess secondary outcomes. The ability to assess the primary outcome of number of participants meeting goal was affected by several factors including: higher than expected participants meeting goal at baseline (based on accelerometers) and higher than expected non-completion rates for the accelerometers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bonny Rockette-Wagner | University of Pittsburgh | 4126240188 | bjr26@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 3, 2025 | Nov 4, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 3, 2025 | Nov 4, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 22, 2022 | Nov 4, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D009765 | Obesity |
| D011236 | Prediabetic State |
| D009043 | Motor Activity |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Participants will be randomized 1:1 to one of two intervention conditions.
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Referring doctors and outcome assessors will be blinded to participant assignment while the study is active. After data collection ends, referring physicians will be informed as to each of their patients assignment. Outcome assessors will remain blinded to participant assignment. Investigators will be blinded to assignment as much as possible. However, certain events ( such as an adverse event report) may cause the study PI to become unblinded.
| PAT | Behavioral | Participants will receive a physical activity tracker and encouragement to increase activity. |
|
| Moderate-vigorous Activity Minutes Over All Timepoints for 12 Months | Objectively measured moderate-vigorous activity at each timepoint using ActiGraph accelerometer worn for 1 week, data for a given timepoint was averaged using only valid days during that week to assess average minutes/day. Valid days are days the monitor was worn for 10 or more hours. | baseline, 6 and 12 months |
| Light Activity Minutes Over All Timepoints for 12 Months | Objectively measured Light activity at each timepoint using ActiGraph accelerometer worn for 1 week, data for a given timepoint was averaged using only valid days during that week to assess average minutes/day. Valid days are days the monitor was worn for 10 or more hours. | baseline, 6 and 12 months |
| Step Counts Over All Timepoints for 12 Months | Objectively measured Step counts at each timepoint using ActiGraph accelerometer worn for 1 week, data for a given timepoint was averaged using only valid days during that week to assess average steps/day. Valid days are days the monitor was worn for 10 or more hours. | baseline, 6 and 12 months |
| Patient Experience | patient experience survey designed for this study with the help of patient partners to gather feedback from participants. Feedback will be used in the development of future interventions | measured at 6 and 12 months |
| Systolic Blood Pressure Over All Timepoints for 12 Months | Taken by trained clinic staff using a validated automated blood pressure cuff after participant is seated in an upright position for 5 minutes. Two measure will be taken and the average of the two measures will be used. If the measures are not within 5 mmHG, a third measure will be taken. | measured at baseline, 6 and 12 months |
| Body Weight Over All Timepoints for 12 Months | will be measured in clinic by trained staff using a validated scale. Participants will be asked to take shoes off and wear light clothes. Average of two measures will be used; if weight is more than .5 pounds different, a third will be taken. | measured at baseline, 6 and 12 months |
| Waist Circumference Over All Timepoints for 12 Months | will be measured above the iliac crest in clinic by trained staff. Two measures will be taken and averaged; if measures are more than 1 cm different a third measure will be taken. | measured at baseline, 6 and 12 months |
| Fasting Blood Glucose Over All Timepoints for 12 Months | A fasting blood draw will be taken after 12-16 hours fast. | measured at baseline, 6 and 12 months |
| HbA1c Over All Timepoints for 12 Months | A fasting blood draw will be taken after 12-16 hours fast. | measured at baseline, 6 and 12 months |
| LDL Cholesterol Over All Timepoints for 12 Months | A fasting blood draw will be taken after 12-16 hours fast. | measured at baseline, 6 and 12 months |
| HDL Cholesterol Over All Timepoints for 12 Months | A fasting blood draw will be taken after 12-16 hours fast. | measured at baseline, 6 and 12 months |
| Perceived Health Score Over All Timepoints for 12 Months | EuroQAL Visual Analogue Scale (EQ-VAS)-Self-reported perception of health on a 0 (lowest possible) to 100 (highest possible) scale. | measured at baseline, 6 and 12 months |
| Insulin Over All Timepoints for 12 Months | A fasting blood draw will be taken after 12-16 hours fast. | measured at baseline, 6 and 12 months |
| Triglycerides Over All Timepoints for 12 Months | A fasting blood draw will be taken after 12-16 hours fast. | measured at baseline, 6 and 12 months |
Participants will receive the ActiveGOALS online program with an integrated activity tracker. ActiveGOALSv2: 13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention. |
| BG002 | Total | Total of all reporting groups |
| 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Meeting Activity Goal | Based on 150 minutes/week from accelerometer | Count of Participants | Participants |
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| Average Moderate-Vigorous Activity | Mean | Standard Deviation | minutes/day |
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| Average Light Activity | Mean | Standard Deviation | minutes/day |
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| Average Sedentary | Mean | Standard Deviation | minutes/day |
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| Average Step Counts | Mean | Standard Deviation | steps/day |
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| Systolic Blood Pressure | Mean | Standard Deviation | mmHG |
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| Body Weight | Mean | Standard Deviation | pounds |
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| Waist Circumference | Mean | Standard Deviation | centimeters |
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| Fasting Blood Glucose | Mean | Standard Deviation | mg/dl |
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| HbA1c | Mean | Standard Deviation | mmol/mol |
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| LDL Cholesterol | Mean | Standard Deviation | mg/dl |
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| HDL Cholesterol | Mean | Standard Deviation | mg/dl |
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| Insulin | Mean | Standard Deviation | mg/dl |
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| Triglycerides | Mean | Standard Deviation | mg/dl |
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| Blood Pressure Diastolic | Mean | Standard Deviation | mmHG |
|
Participants will receive the ActiveGOALS online program with an integrated activity tracker. ActiveGOALSv2: 13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention. |
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| Primary | Change From Baseline in Step Counts at 12 Months | Objectively measured change in step counts between 0 and 12 months using ActiGraph accelerometer | there were less participants with valid data at the 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw | Posted | Jan 2026 | Mean | Standard Error | steps/day | 12 months versus baseline |
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| Secondary | Sedentary Behavior Minutes Over All Timepoints for 12 Months | Objectively measured sedentary behavior at each timepoint using ActiGraph accelerometer worn for 1 week, data for a given timepoint was averaged using only valid days during that week to assess average minutes/day. Valid days are days the monitor was worn for 10 or more hours. | there were less participants with valid data at the 6 month and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw | Posted | Least Squares Mean | Standard Error | minutes | baseline, 6 and 12 months |
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| Secondary | Moderate-vigorous Activity Minutes Over All Timepoints for 12 Months | Objectively measured moderate-vigorous activity at each timepoint using ActiGraph accelerometer worn for 1 week, data for a given timepoint was averaged using only valid days during that week to assess average minutes/day. Valid days are days the monitor was worn for 10 or more hours. | there were less participants with valid data at the 6 month and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw | Posted | Least Squares Mean | Standard Error | minutes | baseline, 6 and 12 months |
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| Secondary | Light Activity Minutes Over All Timepoints for 12 Months | Objectively measured Light activity at each timepoint using ActiGraph accelerometer worn for 1 week, data for a given timepoint was averaged using only valid days during that week to assess average minutes/day. Valid days are days the monitor was worn for 10 or more hours. | there were less participants with valid data at the 6 month and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw | Posted | Least Squares Mean | Standard Error | minutes | baseline, 6 and 12 months |
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| Secondary | Step Counts Over All Timepoints for 12 Months | Objectively measured Step counts at each timepoint using ActiGraph accelerometer worn for 1 week, data for a given timepoint was averaged using only valid days during that week to assess average steps/day. Valid days are days the monitor was worn for 10 or more hours. | there were less participants with valid data at the 6 month and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw | Posted | Least Squares Mean | Standard Error | step counts | baseline, 6 and 12 months |
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| Secondary | Patient Experience | patient experience survey designed for this study with the help of patient partners to gather feedback from participants. Feedback will be used in the development of future interventions | No participants completed the optional questions related to participant experience | Posted | measured at 6 and 12 months |
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| Secondary | Systolic Blood Pressure Over All Timepoints for 12 Months | Taken by trained clinic staff using a validated automated blood pressure cuff after participant is seated in an upright position for 5 minutes. Two measure will be taken and the average of the two measures will be used. If the measures are not within 5 mmHG, a third measure will be taken. | there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw | Posted | Least Squares Mean | Standard Error | mmHG | measured at baseline, 6 and 12 months |
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| Secondary | Body Weight Over All Timepoints for 12 Months | will be measured in clinic by trained staff using a validated scale. Participants will be asked to take shoes off and wear light clothes. Average of two measures will be used; if weight is more than .5 pounds different, a third will be taken. | there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw | Posted | Least Squares Mean | Standard Error | pounds (US) | measured at baseline, 6 and 12 months |
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| Secondary | Waist Circumference Over All Timepoints for 12 Months | will be measured above the iliac crest in clinic by trained staff. Two measures will be taken and averaged; if measures are more than 1 cm different a third measure will be taken. | there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw | Posted | Least Squares Mean | Standard Error | centimeters | measured at baseline, 6 and 12 months |
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| Secondary | Fasting Blood Glucose Over All Timepoints for 12 Months | A fasting blood draw will be taken after 12-16 hours fast. | there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw | Posted | Least Squares Mean | Standard Error | mg/dL | measured at baseline, 6 and 12 months |
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| Secondary | HbA1c Over All Timepoints for 12 Months | A fasting blood draw will be taken after 12-16 hours fast. | there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw | Posted | Least Squares Mean | Standard Error | percentage | measured at baseline, 6 and 12 months |
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| Secondary | LDL Cholesterol Over All Timepoints for 12 Months | A fasting blood draw will be taken after 12-16 hours fast. | there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw | Posted | Least Squares Mean | Standard Error | mg/dL | measured at baseline, 6 and 12 months |
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| Secondary | HDL Cholesterol Over All Timepoints for 12 Months | A fasting blood draw will be taken after 12-16 hours fast. | there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw | Posted | Least Squares Mean | Standard Error | mg/dL | measured at baseline, 6 and 12 months |
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| Secondary | Perceived Health Score Over All Timepoints for 12 Months | EuroQAL Visual Analogue Scale (EQ-VAS)-Self-reported perception of health on a 0 (lowest possible) to 100 (highest possible) scale. | there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw | Posted | Least Squares Mean | Standard Error | score on a scale | measured at baseline, 6 and 12 months |
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| Secondary | Insulin Over All Timepoints for 12 Months | A fasting blood draw will be taken after 12-16 hours fast. | there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw | Posted | Least Squares Mean | Standard Error | IU | measured at baseline, 6 and 12 months |
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| Secondary | Triglycerides Over All Timepoints for 12 Months | A fasting blood draw will be taken after 12-16 hours fast. | there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw | Posted | Least Squares Mean | Standard Error | mg/dL | measured at baseline, 6 and 12 months |
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| 27 |
| EG001 | ActiveGOALSv2 | Participants will receive the ActiveGOALS online program with an integrated activity tracker. ActiveGOALSv2: 13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention. | 0 | 27 | 0 | 27 | 0 | 27 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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