A 12-week digital, multimodal lifestyle intervention significantly reduced systolic blood pressure compared to usual care (adjusted mean difference -8.5 mmHg; P<0.001).
RCT (n=139)
single-blinded
randomized
Does a 12-week digital, multimodal lifestyle program reduce systolic blood pressure in adults with uncontrolled hypertension?
A 12-week digital, multimodal lifestyle intervention significantly reduced systolic and diastolic blood pressure, body weight, and improved quality of life in adults with uncontrolled hypertension.
Standardized Mean Difference: -0.94 (95% CI -1.24–-0.64)
p-value: p=<0.001
Abstract Background Lifestyle intervention is the cornerstone of hypertension therapy for lowering blood pressure, yet effective implementation remains challenging in many countries. App-based interventions have the potential to transform medical care, acting as "in-pocket" coaches. Purpose To evaluate a digital, multimodal lifestyle intervention’s effectiveness in lowering blood pressure and improving body weight, HRQoL, and health literacy. Methods In a decentralized, single-blinded trial, we tested a 12-week digital, multimodal lifestyle program in adults with uncontrolled hypertension (diagnosed by home measurement). Participants were randomized to the program plus care as usual or care as usual alone. The primary outcome was the group difference of mean systolic blood pressure (SBP) by HBPM at 12 weeks. Secondary outcomes were mean diastolic BP (DBP), and changes in body weight, health-related quality of life (HRQoL), and health literacy from baseline to 12 weeks. An intention-to-treat analysis with baseline-controlled ANCOVA and multiple imputation by chained equations (MICE) was performed, supplemented by sensitivity and subgroup analyses. Results A total of 139 patients were randomized (Intervention = 71, Control = 68), 55% were females, mean baseline BP was 142/88 mmHg. After 12 weeks, there was a significantly lower SBP in the intervention group (adjusted mean difference = -8.5 mmHg, p 0.001, d = -0.94, CI 95% = -1.24, -0.64, Figure 1a). 75.8% of patients in the intervention group achieved a meaningful reduction of ≥ 5 mmHg in SBP compared to 35.9% in the control group (Odds ratio = 5.78, CI 95% = 2.67, 13.2). DBP in the digital intervention group was also significantly lower (-5.06 mmHg, p 0.001), as well as a larger relative reduction in body weight (-2.88 %, p 0.001), and larger improvements in HRQoL (5.69 points, p 0.001), and food literacy (4.74 points, p 0.001) (Figure 1b). Treatment effects were also stable across subgroups and sensitivity analyses. Conclusion Reduced blood pressure emerged as a key benefit following 12-week digital intervention. Concurrent improvements in weight, HRQoL and food literacy underscore the broad-based impact of addressing multiple lifestyle factors simultaneously. These combined benefits highlight the potential clinical value of a comprehensive, lifestyle-focused digital approach for managing essential hypertension and warrant larger and longer trials to further establish their sustained impact and scalability.
Limbourg et al. (Sat,) conducted a rct in essential hypertension (n=139). Digital, multimodal lifestyle program vs. Care as usual alone was evaluated on Group difference of mean systolic blood pressure (SBP) by HBPM at 12 weeks (MD -8.5 mmHg (d = -0.94), 95% CI -1.24 to -0.64, p=<0.001). A 12-week digital, multimodal lifestyle intervention significantly reduced systolic blood pressure compared to usual care (adjusted mean difference -8.5 mmHg; P<0.001).