Home Blood Pressure‐Guided Lifestyle Intervention for Elevated Blood Pressure Detected at Workplace Health Checkups: A Randomized Pilot Trial

Figures

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  FIGURE 1. Flow diagram of participant screening, recruitment, enrollment, randomization, and follow‐up. Of 515 employees who underwent the January 2023 workplace health checkup, 129 had SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg. All 129 received a study overview and invitation to participate; 58 applied, and all 58 provided written informed consent and met the eligibility criteria. No consent was withdrawn before or after study initiation, no participant was excluded for failure to meet the eligibility criteria, and all 58 participants were randomized and completed follow‐up.

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  FIGURE 2. Study timeline and counseling schedule by randomized group. Both groups had two scheduled physician‐led counseling sessions: an initial session and a second session approximately 3 months later. The intervention group performed home BP monitoring for at least 7 days before each session; the control group did not receive study‐provided home BP monitoring. The January 2024 workplace health checkup provided the study outcomes and was not used for within‐study referral decisions.

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  FIGURE 3. Blood pressure reassessment and referral criteria by randomized group. Both groups received the same two scheduled physician‐led lifestyle counseling sessions and the same guideline‐based lifestyle topics. In the intervention group, the most recent 7‐day mean home BP was used for BP reassessment; at the 3‐month session, mean home BP ≥ 135/85 mmHg prompted a recommendation for medical consultation. In the control group, January 2023 workplace health checkup BP was used initially and BP measured at the 3‐month counseling visit was used for reassessment; visit BP ≥ 140/90 mmHg prompted a recommendation for medical consultation. Participants at high cardiovascular risk were advised to seek medical care in both groups irrespective of these BP thresholds, and the recommendation was reinforced at follow‐up if medical care had not been obtained. BP indicates blood pressure. High cardiovascular risk was defined according to the Japanese Society of Hypertension Guidelines for the Management of Hypertension 2019, as described in the Methods.