作者
Hongyi Du,Xuezhu Sun,S Y Zhang,Baolu Wang,Meice Tian,Juan Deng,Li Du,Peng Wang,Mingzhao Du,Xu Yang,Yutian Zhu,Qi Xie,Zijing Zeng,X L Feng
摘要
Abstract BACKGROUND Cardiorespiratory fitness (CRF) is a strong predictor of cardiovascular risk, yet scalable approaches to improve CRF among adults with high-normal or high blood pressure (BP) remain limited. Telehealth lifestyle programs may address this gap, but trials with rigorous CRF endpoints are scarce. METHODS We conducted a two-center, assessor-blinded, randomized controlled trial in Beijing and Shenzhen, China, from July 2022 to September 2024. Adults with high-normal or high BP were enrolled and randomized 1:1 to a telehealth-based lifestyle modification program (Tele-LM) or enhanced usual care (EUC), stratified by BP category. Tele-LM combined app-based dietary coaching, individualized aerobic and resistance prescriptions, home BP monitoring, and motivational interviewing. EUC comprised standardized lifestyle counseling, home BP monitoring, and educational resources. The primary outcome was change in peak oxygen uptake (VO 2peak ) at 3 months. Secondary outcomes included changes in VO 2peak at 9 months, home, ambulatory and office BP, lifestyle behaviors, metabolic parameters, and medication use. Analyses followed the intention-to-treat principle with multiple imputation for missing data. RESULTS Among 424 randomized participants (mean age 50 years; 65% men), 314 completed the 3-month assessment and 377 completed the 9-month assessment. At 3 months, the adjusted between-group difference in VO 2peak change favored Tele-LM by 1.5 mL/kg/min (95% confidence interval [CI], 0.6 to 2.3; P =0.001); at 9 months, a smaller difference persisted (1.0 mL/kg/min [95%CI, 0.1 to 1.9]; P =0.027). Subgroup analyses by BP category (randomization strata) revealed no significant heterogeneity for VO 2peak . Tele-LM produced greater 3-month reductions in home BP (systolic BP −3.3 mmHg [95% CI, −5.3 to −1.4]; diastolic BP −2.6 mmHg [95%CI, −3.9 to −1.3]) and in 24-hour ambulatory BP (systolic BP −3.3 mmHg [95%CI, −6.0 to −0.6]; diastolic BP −1.9 mmHg [95%CI, −3.6 to −0.3]); between-group differences generally attenuated by 9 months. Adverse events were infrequent and similar between groups; no serious adverse events were observed. Average antihypertensive medication intensity was modestly lower in the Tele-LM (−0.27 agents [95% CI, −0.44 to −0.10]). Findings were consistent across prespecified sensitivity analyses. CONCLUSIONS In adults with high-normal or high BP, telehealth lifestyle modification with minimal in-person contact significantly improved CRF and modestly lowered BP, supporting its scalability as a complement to routine hypertension care. REGISTRATION URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05528068 . Clinical Perspective What Is New? This randomized trial evaluated a comprehensive telehealth-based lifestyle modification program, combining app-based dietary coaching, individualized aerobic and resistance prescriptions, wearable integration and motivational interviewing, in adults with high-normal blood pressure or well-controlled hypertension. Telehealth-based lifestyle modification significantly improved cardiorespiratory fitness and modestly reduced blood pressure compared with enhanced usual care. What Are the Clinical Implications? Telehealth lifestyle programs can extend preventive care to large at-risk populations with minimal in-person contact. By reducing reliance on pharmacologic intensification and conserving healthcare resources, telehealth-based strategies offer a cost-effective model for scalable cardiovascular prevention. Sustaining adherence remains essential to maximize long-term benefits.