Trial results for The Clinical Referral to Activity Study, investigating physical activity interventions for conditions including obesity, were posted on ClinicalTrials.gov on 2025-11-19. The study enrolled 54 participants.
Background
Obesity and physical inactivity are significant public health challenges, contributing to an increased risk of cardiovascular disease, high blood pressure, and prediabetes. Effective interventions that promote physical activity are crucial for managing these conditions and improving long-term health outcomes. This study aimed to evaluate a specific physical activity intervention designed for adult clinical care patients who are at risk of developing cardiovascular disease, with the goal of increasing their physical activity levels.
Trial design
This completed study, designated as Phase NA, enrolled 54 participants. The trial investigated interventions for conditions including Physical Inactivity, Cardiovascular Risk Factor, Obesity, Blood Pressure, and PreDiabetes. The intervention, named ActiveGOALSv2, included social-cognitive theory-based sessions, remote coaching, and a body-worn physical activity tracker (PAT), delivered online over one year. The comparator group received a body-worn physical activity monitor (PAT) as an active control. The investigators hypothesized that the ActiveGOALSv2 intervention would be more successful at increasing physical activity, defined as objectively measured step counts and the percentage of individuals meeting the moderate-vigorous physical activity goal, compared to the active control group.
Key results
The trial reported several key measurements and analyses at 12 months:
- Change From Baseline in Meeting the Aerobic Activity Goal at 12 Months:
- In the ActiveGOALSv2 group, 18 participants met the goal.
- In the PAT (Physical Activity Monitor) group, 14 participants met the goal.
- In another measurement for the ActiveGOALSv2 group, 14 participants met the goal.
- In another measurement for the PAT (Physical Activity Monitor) group, 11 participants met the goal.
- Change From Baseline in Step Counts at 12 Months:
- The ActiveGOALSv2 group showed a mean change of 5028.41 steps/day (Standard Error 413.78).
- The PAT (Physical Activity Monitor) group showed a mean change of 4574.21 steps/day (Standard Error 421.86).
- In another measurement, the ActiveGOALSv2 group showed a mean change of 5680.49 steps/day (Standard Error 416.41).
- In another measurement, the PAT (Physical Activity Monitor) group showed a mean change of 4533.67 steps/day (Standard Error 416.42).
- Sedentary Behavior Minutes Over All Timepoints for 12 Months:
- The ActiveGOALSv2 group had a Least Squares Mean of 461.00 minutes (Standard Error 17.52).
- The PAT (Physical Activity Monitor) group had a Least Squares Mean of 457.42 minutes (Standard Error 17.84).
- In another measurement, the ActiveGOALSv2 group had a Least Squares Mean of 456.61 minutes (Standard Error 27.96).
- In another measurement, the PAT (Physical Activity Monitor) group had a Least Squares Mean of 496.83 minutes (Standard Error 26.05).
Mixed Models Analysis for the mean difference in final step counts between groups yielded a value of -1106.28 with a p-value of 0.0665. Other Mixed Models Analysis p-values reported included 0.63, 0.5, 0.79, 0.28, and 0.07.
What this means
The posted results indicate that the ActiveGOALSv2 intervention numerically increased step counts and the number of participants meeting aerobic activity goals compared to the PAT-only control group over 12 months. While the mean difference in step counts showed a trend towards improvement for ActiveGOALSv2, the reported p-values, including 0.0665 for step counts, did not reach conventional statistical significance (p < 0.05). These findings suggest that comprehensive physical activity interventions, including remote coaching and social-cognitive theory-based sessions, may offer benefits for individuals with obesity and cardiovascular risk factors, warranting further investigation into their impact on long-term health outcomes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04743856, titled "The Clinical Referral to Activity Study", were posted on 2025-11-19 on clinicaltrials.gov.