N/A
Completed N=40
A Study to Test the Effectiveness of Different Interventions to Improve Physical Activity in Adults.
Healthy
Source: ClinicalTrials.gov NCT04902014 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Change in Motivation From Baseline at 12 Weeks. — 0.30; 0.48; 0.40; 0.43 Units on a scale
Summary
During the initial months of the COVID-19 pandemic, physical activity (PA) engagement levels declined worldwide. Despite the overwhelming adoption of wearable fitness tracker (WFT) devices, it continues to be unclear as to their effect on PA engagement or PA motivation. Building on past research, we hypothesized that combining a WFT with a known impactful intervention, motivational interviewing (MI) would positively influence both self-determination theory (SDT) motivation and PA during an unprecedented global emergency.
A four-group randomized controlled study was conducted amongst 40 inactive adults over a 12-week period during the COVID-19 pandemic. One group (WFT, n = 10) received a wearable fitness tracker, a second (MI, n=10) received bi-weekly MI sessions, a third (WFT+, n=10) received both, and a fourth (Education, n=10) received basic PA education. Outcome measures for motivation and PA were measured though an online survey before and after the 12-week period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Motivation From Baseline at 12 Weeks. |
0.30; 0.48; 0.40; 0.43; 1.58; 1.45 | — |
| PRIMARY Change in Moderate to Vigorous Physical Activity From Baseline at 12 Weeks. |
66.70; 67.75; 76.37; 71.08; 66.17; 64.00 | — |
| PRIMARY Change in Steps Per Day From Baseline at 12 Weeks. |
6155.58; 5400.56; 6693.01; 6232.15; 6216.31; 5211.16 | — |
Eligibility Criteria
Inclusion Criteria
- Females or males, aged 18 or older,
- does not currently engage in 150 minutes of moderate to vigorous PA per week,
- owns an Android, or iPhone smartphone device,
- is willing to download a mobile app to be used on the smartphone device, 5) is willing to wear a small, wrist worn fitness tracker for the duration of the study, and 6) is be willing to attend 6 biweekly MI sessions over 12 weeks.
Exclusion Criteria
- a history of myocardial infarction, angina, coronary artery bypass surgery, congestive heart failure, or diabetes,
- limiting conditions such as concurrent cancer treatment, peripheral artery disease, orthopedic injury, or pain limiting arthritis,
- seeking to participate in other structured PA programs during the duration of the study,
- pregnant at the initiation of the study or plans to become pregnant during the study, and
- alcohol or other substance abuse within the previous 12 months.
Data sourced from ClinicalTrials.gov (NCT04902014). 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.