Blood Pressure, Cardiovascular Risk Factor, Obesity, Physical Inactivity, PreDiabetes
Conditions
Keywords
Physical activity, Online lifestyle Intervention, Cardiovascular disease, Disease prevention
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALActiveGOALSv2
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.
BEHAVIORALPAT
Participants will receive a physical activity tracker and encouragement to increase activity.
Sponsors
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomized 1:1 to one of two intervention conditions.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
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: * high blood pressure:\> 129 mm hg SP or \>89 mm hg DP or medication * high fasting glucose:\>100 mg/dl or high HbA1c: ≥42 mmols/mol or medication * overweight/ obesity: BMI ≥25 kg/m2). * 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
* Have participated in a physical activity intervention program with behavior tracking and goal setting in the past year. * Told by a physician that they have diabetes (other than previous gestational diabetes) or have received a diagnosis of cardiovascular disease, regardless of when. * Pregnant or planning a pregnancy in \<12 months * Non-ambulatory or planning a procedure that will lead to not being ambulatory in \<12 months. * Women who become pregnant during the study will be required to get an updated referral form from their primary care provider (PCP) stating that they are able to increase their physical activity without supervision .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Meeting the Aerobic Activity Goal at 12 Months | 12 months versus baseline | 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 |
| Change From Baseline in Step Counts at 12 Months | 12 months versus baseline | Objectively measured change in step counts between 0 and 12 months using ActiGraph accelerometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedentary Behavior Minutes Over All Timepoints for 12 Months | baseline, 6 and 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. |
| Moderate-vigorous Activity Minutes Over All Timepoints for 12 Months | baseline, 6 and 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. |
| Light Activity Minutes Over All Timepoints for 12 Months | baseline, 6 and 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. |
| Step Counts Over All Timepoints for 12 Months | baseline, 6 and 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. |
| Patient Experience | measured at 6 and 12 months | 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 |
| Systolic Blood Pressure Over All Timepoints for 12 Months | measured at baseline, 6 and 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. |
| Body Weight Over All Timepoints for 12 Months | measured at baseline, 6 and 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. |
| Waist Circumference Over All Timepoints for 12 Months | measured at baseline, 6 and 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. |
| Fasting Blood Glucose Over All Timepoints for 12 Months | measured at baseline, 6 and 12 months | A fasting blood draw will be taken after 12-16 hours fast. |
| HbA1c Over All Timepoints for 12 Months | measured at baseline, 6 and 12 months | A fasting blood draw will be taken after 12-16 hours fast. |
| LDL Cholesterol Over All Timepoints for 12 Months | measured at baseline, 6 and 12 months | A fasting blood draw will be taken after 12-16 hours fast. |
| HDL Cholesterol Over All Timepoints for 12 Months | measured at baseline, 6 and 12 months | A fasting blood draw will be taken after 12-16 hours fast. |
| Perceived Health Score Over All Timepoints for 12 Months | measured at baseline, 6 and 12 months | EuroQAL Visual Analogue Scale (EQ-VAS)-Self-reported perception of health on a 0 (lowest possible) to 100 (highest possible) scale. |
| Insulin Over All Timepoints for 12 Months | measured at baseline, 6 and 12 months | A fasting blood draw will be taken after 12-16 hours fast. |
| Triglycerides Over All Timepoints for 12 Months | measured at baseline, 6 and 12 months | A fasting blood draw will be taken after 12-16 hours fast. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBonny Rockette-Wagner, PhD
University of Pittsburgh
Participant flow
Recruitment details
Participants enrolled between March 2022 and June 2023.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 27 |
| 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. | 27 |
| Total | 54 |
Baseline characteristics
| Characteristic | PAT (Physical Activity Monitor) | ActiveGOALSv2 | Total |
|---|---|---|---|
| Age, Continuous | 57.01 years STANDARD_DEVIATION 8.31 | 57.7 years STANDARD_DEVIATION 9.26 | 57.36 years STANDARD_DEVIATION 8.73 |
| Average Light Activity | 338.5 minutes/day STANDARD_DEVIATION 86.7 | 354.1 minutes/day STANDARD_DEVIATION 94.1 | 346.5 minutes/day STANDARD_DEVIATION 90.1 |
| Average Moderate-Vigorous Activity | 29.6 minutes/day STANDARD_DEVIATION 22.6 | 34.83 minutes/day STANDARD_DEVIATION 23.48 | 32.3 minutes/day STANDARD_DEVIATION 23 |
| Average Sedentary | 455.91 minutes/day STANDARD_DEVIATION 66.1 | 463.27 minutes/day STANDARD_DEVIATION 112.57 | 459.65 minutes/day STANDARD_DEVIATION 91.9 |
| Average Step Counts | 4564 steps/day STANDARD_DEVIATION 2141 | 5023 steps/day STANDARD_DEVIATION 2222 | 4797 steps/day STANDARD_DEVIATION 2174 |
| Blood Pressure Diastolic | 79 mmHG STANDARD_DEVIATION 11 | 79 mmHG STANDARD_DEVIATION 9 | 79 mmHG STANDARD_DEVIATION 10 |
| Body Weight | 216.8 pounds STANDARD_DEVIATION 29.9 | 207.4 pounds STANDARD_DEVIATION 33.1 | 212.0 pounds STANDARD_DEVIATION 31.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 26 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fasting Blood Glucose | 96.7 mg/dl STANDARD_DEVIATION 14.5 | 102.6 mg/dl STANDARD_DEVIATION 16.5 | 99.7 mg/dl STANDARD_DEVIATION 15.7 |
| HbA1c | 5.42 mmol/mol STANDARD_DEVIATION 0.46 | 5.62 mmol/mol STANDARD_DEVIATION 0.55 | 5.52 mmol/mol STANDARD_DEVIATION 0.52 |
| HDL Cholesterol | 54.7 mg/dl STANDARD_DEVIATION 13 | 53.0 mg/dl STANDARD_DEVIATION 15.7 | 53.9 mg/dl STANDARD_DEVIATION 14.3 |
| Insulin | 15.9 mg/dl STANDARD_DEVIATION 15.1 | 16.0 mg/dl STANDARD_DEVIATION 10.1 | 16.0 mg/dl STANDARD_DEVIATION 12.7 |
| LDL Cholesterol | 116.4 mg/dl STANDARD_DEVIATION 43.5 | 118.9 mg/dl STANDARD_DEVIATION 43.4 | 117.6 mg/dl STANDARD_DEVIATION 43.1 |
| Meeting Activity Goal | 14 Participants | 18 Participants | 32 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 19 Participants | 38 Participants |
| Sex: Female, Male Female | 24 Participants | 20 Participants | 44 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 10 Participants |
| Systolic Blood Pressure | 122.6 mmHG STANDARD_DEVIATION 17.1 | 120.6 mmHG STANDARD_DEVIATION 11.9 | 121.6 mmHG STANDARD_DEVIATION 14.6 |
| Triglycerides | 128.9 mg/dl STANDARD_DEVIATION 54.1 | 162.1 mg/dl STANDARD_DEVIATION 108.8 | 145.5 mg/dl STANDARD_DEVIATION 86.7 |
| Waist Circumference | 112.8 centimeters STANDARD_DEVIATION 16.2 | 108.2 centimeters STANDARD_DEVIATION 10.6 | 110.5 centimeters STANDARD_DEVIATION 13.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
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
Time frame: 12 months versus baseline
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PAT (Physical activity monitor) | Change From Baseline in Meeting the Aerobic Activity Goal at 12 Months | Baseline meeting goal | 11 Participants |
| PAT (Physical activity monitor) | Change From Baseline in Meeting the Aerobic Activity Goal at 12 Months | 12 months meeting goal | 11 Participants |
| ActiveGOALSv2 | Change From Baseline in Meeting the Aerobic Activity Goal at 12 Months | Baseline meeting goal | 16 Participants |
| ActiveGOALSv2 | Change From Baseline in Meeting the Aerobic Activity Goal at 12 Months | 12 months meeting goal | 13 Participants |
p-value: 0.63Mixed Models Analysis
Primary
Change From Baseline in Step Counts at 12 Months
Objectively measured change in step counts between 0 and 12 months using ActiGraph accelerometer
Time frame: 12 months versus baseline
Population: there were less participants with valid data at the 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PAT (Physical activity monitor) | Change From Baseline in Step Counts at 12 Months | Baseline Adjusted Estimates | 4574.21 steps/day | Standard Error 421.86 |
| PAT (Physical activity monitor) | Change From Baseline in Step Counts at 12 Months | 12 month Adjusted Estimates | 4533.67 steps/day | Standard Error 416.42 |
| ActiveGOALSv2 | Change From Baseline in Step Counts at 12 Months | Baseline Adjusted Estimates | 5028.41 steps/day | Standard Error 413.78 |
| ActiveGOALSv2 | Change From Baseline in Step Counts at 12 Months | 12 month Adjusted Estimates | 5680.49 steps/day | Standard Error 416.41 |
p-value: 0.0665Mixed Models Analysis
Secondary
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.
Time frame: measured at baseline, 6 and 12 months
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.
Time frame: measured at baseline, 6 and 12 months
Secondary
Fasting Blood Glucose Over All Timepoints for 12 Months
A fasting blood draw will be taken after 12-16 hours fast.
Time frame: measured at baseline, 6 and 12 months
Secondary
HbA1c Over All Timepoints for 12 Months
A fasting blood draw will be taken after 12-16 hours fast.
Time frame: measured at baseline, 6 and 12 months
Secondary
HDL Cholesterol Over All Timepoints for 12 Months
A fasting blood draw will be taken after 12-16 hours fast.
Time frame: measured at baseline, 6 and 12 months
Secondary
Insulin Over All Timepoints for 12 Months
A fasting blood draw will be taken after 12-16 hours fast.
Time frame: measured at baseline, 6 and 12 months
Secondary
LDL Cholesterol Over All Timepoints for 12 Months
A fasting blood draw will be taken after 12-16 hours fast.
Time frame: measured at baseline, 6 and 12 months
Secondary
Light Activity Minutes Over All Timepoints for 12 Months
Objectively measured Light activity over all timepoints for 12 months using ActiGraph accelerometer
Time frame: 1 week recording; measured at baseline, 6 and 12 months
Secondary
Moderate-vigorous Activity Minutes Over All Timepoints for 12 Months
Objectively measured moderate-vigorous activity over all timepoints for 12 months using ActiGraph accelerometer
Time frame: 1 week recording; measured at baseline, 6 and 12 months
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
Time frame: measured at 6 and 12 months
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.
Time frame: measured at baseline, 6 and 12 months
Secondary
Sedentary Behavior Minutes Over All Timepoints for 12 Months
Objectively measured sedentary behavior over all timepoints for 12 months using ActiGraph accelerometer
Time frame: 1 week recording; measured at baseline, 6 and 12 months
Secondary
Step Counts Over All Timepoints for 12 Months
Objectively measured Step counts over all timepoints for 12 months using ActiGraph accelerometer
Time frame: 1 week recording; measured at baseline, 6 and 12 months
Secondary
Triglycerides Over All Timepoints for 12 Months
A fasting blood draw will be taken after 12-16 hours fast.
Time frame: measured at baseline, 6 and 12 months
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.
Time frame: measured at baseline, 6 and 12 months