N/A
Completed N=54
The Clinical Referral to Activity Study
Physical Inactivity · Cardiovascular Risk Factor · Obesity · Blood Pressure
Source: ClinicalTrials.gov NCT04743856 ↗
Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Change From Baseline in Meeting the Aerobic Activity Goal at 12 Months — 14; 18; 11; 14 Participants — p=0.63
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Meeting the Aerobic Activity Goal at 12 Months |
14; 18; 11; 14 | 0.63 |
| PRIMARY Change From Baseline in Step Counts at 12 Months |
4574.21; 5028.41; 4533.67; 5680.49 | 0.0665 |
| SECONDARY Sedentary Behavior Minutes Over All Timepoints for 12 Months |
457.42; 461.00; 496.83; 456.61; 464.21; 446.26 | 0.50 |
| SECONDARY Moderate-vigorous Activity Minutes Over All Timepoints for 12 Months |
29.73; 34.82; 27.41; 33.37; 30.31; 38.54 | 0.79 |
| SECONDARY Light Activity Minutes Over All Timepoints for 12 Months |
338.37; 353.69; 325.93; 359.25; 324.94; 372.73 | 0.28 |
| SECONDARY Step Counts Over All Timepoints for 12 Months |
4583.96; 5024.89; 4436.42; 5104.16; 4350.15; 5724.75 | 0.07 |
| SECONDARY Patient Experience |
— | — |
| SECONDARY Systolic Blood Pressure Over All Timepoints for 12 Months |
122.62; 120.60; 125.46; 123.79; 119.87; 118.56 | 0.99 |
| SECONDARY Body Weight Over All Timepoints for 12 Months |
216.87; 207.41; 217.90; 205.65; 218.44; 207.83 | 0.41 |
| SECONDARY Waist Circumference Over All Timepoints for 12 Months |
112.78; 108.24; 109.12; 108.48; 111.25; 110.01 | 0.41 |
| SECONDARY Fasting Blood Glucose Over All Timepoints for 12 Months |
96.80; 102.56; 96.74; 100.15; 100.36; 106.09 | 0.83 |
| SECONDARY HbA1c Over All Timepoints for 12 Months |
5.42; 5.63; 5.52; 5.60; 5.61; 5.82 | 0.25 |
| SECONDARY LDL Cholesterol Over All Timepoints for 12 Months |
116.52; 119.66; 119.07; 115.90; 118.23; 123.07 | 0.44 |
| SECONDARY HDL Cholesterol Over All Timepoints for 12 Months |
54.70; 53.04; 55.01; 53.83; 51.78; 51.41 | 0.81 |
| SECONDARY Perceived Health Score Over All Timepoints for 12 Months |
71.23; 72.15; 68.05; 72.28; 71.95; 72.92 | 0.51 |
| SECONDARY Insulin Over All Timepoints for 12 Months |
14.27; 15.52; 12.79; 14.47; 15.95; 17.83 | 0.97 |
| SECONDARY Triglycerides Over All Timepoints for 12 Months |
128.85; 162.16; 139.81; 146.89; 146.28; 166.11 | 0.15 |
Eligibility Criteria
Inclusion Criteria
- Age 40-70 years of age
- Low physical activity (PA) levels ( 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 .
Data sourced from ClinicalTrials.gov (NCT04743856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.