Feasibility and Preliminary Efficacy of a “Sit Less” Program Leveraging Fitbit Tracking and Tailored Text Messages in Cardiometabolic Disease: Findings from Two Parallel Randomized Controlled Trials in Coronary Artery Disease and Type 2 Diabetes (Preprint)
Bibliographic record
Abstract
BACKGROUND: Individuals with cardiometabolic disease typically average 10-14 hours of daily sedentary time, which increases the risk for cardiovascular disease (CVD). OBJECTIVE: To evaluate the feasibility, acceptability, and preliminary efficacy of a "Sit Less" program in reducing sedentary behavior in people with cardiometabolic disease. METHODS: Participants with CVD or type 2 diabetes (T2D) underwent separate randomization into the Sit Less intervention or control group. Sit Less included one in-person counseling session, a Fitbit, a smart water bottle, and tailored weekly text messages for 12 weeks. Control group participants received the American Heart Association's "Answers by Heart" booklet. Sedentary behavior was measured using activPAL for 7 days at baseline and post-intervention. Secondary outcomes included physical activity, cardiometabolic biomarkers, continuous glucose monitoring (CGM) metrics, and psychological factors. Generalized linear models estimated adjusted between-group differences controlling for baseline values, cohort, cohort × group interaction, and leisure-time exercise. RESULTS: Of 37 randomized participants, 35 (95%) completed the study (Sit Less: 17; Control: 18). Of the 35 that completed the study, 62% were male, median age was 67 years, and their baseline sedentary time was approximately 10.4 hours/day. Sit Less participants demonstrated high adherence, including a text response rate of 81% and median Fitbit wear of 15 hours/day on 6.8 days/week, and 15 out of 17 participants (88%) reported satisfaction with the program. Compared with the control group, Sit Less participants showed greater reductions in total sedentary time (adjusted mean difference -17.3 min/day, 95% CI -63 to 28; P=.45), prolonged sedentary time >30 minutes (-39.5 min/day, 95% CI -100 to 21; P=.20) and >60 minutes (-49.9 min/day, 95% CI -102 to 2; P=.06), and increases in sit-to-stand transitions (4.2/day, 95% CI -2 to 10; P=.13), although none were statistically significant. HbA1c was lower in the Sit Less group compared with the control group (adjusted mean difference -0.4%, 95% CI -0.8 to -0.1; P=.04). CGM outcomes, including mean glucose (-6.0 mg/dL, 95% CI -14.9 to 2.8; P=.18) and time in range (2.1%, 95% CI -4.8 to 9.1; P=.54), were not statistically significant but demonstrated similar directional changes. Other cardiometabolic biomarkers, physical activity, and psychological outcomes were not significantly different, except for lower self-efficacy for moderate physical activity in the Sit Less group (-0.6, 95% CI -1.1 to -0.2; P=.003). CONCLUSIONS: The Sit Less intervention was feasible and acceptable and showed possible improvements in sedentary behavior and glycemic outcomes. Although this pilot study had a small sample size and limited statistical power, with multiple outcomes examined and wide confidence intervals observed, these findings support evaluation in larger, adequately powered trials. CLINICALTRIAL: ClinicalTrials.gov NCT05534256, NCT05691452. INTERNATIONAL REGISTERED REPORT: RR2-10.1371/journal.pone.0302582.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.008 | 0.014 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.003 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.010 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".