Mobile health, exercise and metabolic risk: a randomized controlled trial

Robert J Petrella, Melanie I Stuckey, Sheree Shapiro, Dawn P Gill, Robert J Petrella, Melanie I Stuckey, Sheree Shapiro, Dawn P Gill

Abstract

Background: It was hypothesized that a mobile health (mHealth) intervention would elicit greater improvements in systolic blood pressure and other cardiometabolic risk factors at 12 weeks, which would be better maintained over 52 weeks, compared to the active control intervention.

Methods: Eligible participants (≥2 metabolic syndrome risk factors) were randomized to the mHealth intervention (n = 75) or the active control group (n = 74). Blood pressure and other cardiometabolic risk factors were measured at baseline and at 12, 24 and 52 weeks. Both groups received an individualized exercise prescription and the intervention group additionally received a technology kit for home monitoring of biometrics and physical activity.

Results: Analyses were conducted on 67 participants in the intervention group (aged 56.7 ± 9.7 years; 71.6% female) and 60 participants in the active control group (aged 59.1 ± 8.4 years; 76.7% female). At 12 weeks, baseline adjusted mean change in systolic blood pressure (primary outcome) was greater in the active control group compared to the intervention group (-5.68 mmHg; 95% CI -10.86 to -0.50 mmHg; p = 0.03), but there were no differences between groups in mean change for secondary outcomes. Over 52-weeks, the difference in mean change for systolic blood pressure was no longer apparent between groups, but remained significant across the entire population (time: p < 0.001).

Conclusions: In participants with increased cardiometabolic risk, exercise prescription alone had greater short-term improvements in systolic blood pressure compared to the mHealth intervention, though over 52 weeks, improvements were equal between interventions.

Trial registration: ClinicalTrials.gov http://NCT01944124.

Figures

Figure 1
Figure 1
Mobile health technologies. Solid line = flow of information; dotted line = measurement transmitted from device to smartphone via Bluetooth® connection; dashed line = measurement manually inputted to smartphone.
Figure 2
Figure 2
Participant flow.
Figure 3
Figure 3
Long-term results for blood pressure, waist circumference and glucose-related outcomes (Means ± SEM presented). Presents change in A) systolic blood pressure (SBP); B) diastolic blood pressure (DBP); C) waist circumference (WC); D) fasting plasma glucose (FG); E) glycated hemoglobin (HbA1c); and F) homeostasis model for insulin resistance (HOMA-IR) over time. *p <0.05 (from post-hoc analyses using the Bonferroni method) White triangles = intervention group; black circles = active control group.
Figure 4
Figure 4
Long-term results for lipid-related outcomes and CRPhs(Means ± SEM presented). Presents change in A) high density lipoprotein cholesterol (HDL); B) low density lipoprotein cholesterol (LDL); C) total cholesterol (T-Chol); D) triglycerides (TG); and E) high sensitivity C-reactive protein (CRPhs) over time. *p <0.05 (from post-hoc analyses using the Bonferroni method) White triangles = intervention group; black circles = active control group.

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Pre-publication history
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