Clinical trial NCT04743856: The Clinical Referral to Activity Study
Official title: Advancement of Clinical Referral to Physical Activity for Cardiometabolic Disease Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Cardiovascular Risk Factor
Obesity
Blood Pressure
PreDiabetes
Keywords: Physical activity
Online lifestyle Intervention
Cardiovascular disease
Disease prevention
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-02-08
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to one of two intervention conditions.
Primary purpose: 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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Change from baseline in meeting the aerobic activity goal at 12 months
timeFrame: 12 months versus baseline
measure: Change from baseline in Step counts at 12 months
timeFrame: 12 months versus baseline
Secondary outcomes:
measure: Sedentary behavior minutes over all timepoints for 12 months
timeFrame: 1 week recording; measured at baseline, 6 and 12 months
measure: Moderate-vigorous activity minutes over all timepoints for 12 months
timeFrame: 1 week recording; measured at baseline, 6 and 12 months
measure: Light activity minutes over all timepoints for 12 months
timeFrame: 1 week recording; measured at baseline, 6 and 12 months
measure: Step counts over all timepoints for 12 months
timeFrame: 1 week recording; measured at baseline, 6 and 12 months
measure: Patient experience
timeFrame: measured at 6 and 12 months
measure: Blood Pressure over all timepoints for 12 months
timeFrame: measured at baseline, 6 and 12 months
measure: Body Weight over all timepoints for 12 months
timeFrame: measured at baseline, 6 and 12 months
measure: Waist Circumference over all timepoints for 12 months
timeFrame: measured at baseline, 6 and 12 months
measure: Fasting Blood Glucose over all timepoints for 12 months
timeFrame: measured at baseline, 6 and 12 months
measure: HbA1c over all timepoints for 12 months
timeFrame: measured at baseline, 6 and 12 months
measure: LDL Cholesterol over all timepoints for 12 months
timeFrame: measured at baseline, 6 and 12 months
measure: HDL Cholesterol over all timepoints for 12 months
timeFrame: measured at baseline, 6 and 12 months
measure: Perceived Health Score over all timepoints for 12 months
timeFrame: measured at baseline, 6 and 12 months
measure: Insulin over all timepoints for 12 months
timeFrame: measured at baseline, 6 and 12 months
measure: Triglycerides over all timepoints for 12 months
timeFrame: measured at baseline, 6 and 12 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Bonny Rockette-Wagner, PhD
role: PRINCIPAL_INVESTIGATOR
References: