Blood Pressure Reduction in Multiomic Digital Food-as-Medicine: a single-arm cohort study with a regression-to-the-mean-adjusted estimand
- 1Digbi Health
Abstract
1Elevated systolic blood pressure (SBP) is a major modifiable driver of cardiovascular morbidity. Digital food-as-medicine and home-blood-pressure-monitoring programs increasingly support its management outside the clinic, but most published evaluations are single-arm, pre/post designs; because enrolment is conditioned on an elevated baseline reading, regression to the mean (RTM) is expected to inflate any observed improvement, and this is rarely checked against an internal comparator. We conducted a retrospective, single-arm cohort study of home blood-pressure monitoring within a commercial digital food-as-medicine program serving a US employer-sponsored population with obesity. Of 329 members included, 136 were at-goal (<130/80 mmHg), 74 at Stage 1 (130-134/80-84 mmHg) and 119 at Stage 2 ([≥]135/85 mmHg) at baseline; follow-up SBP was evaluable for 128, 68 and 112 members in these strata at 3 months and for 62, 34 and 53 at 6 months, respectively. The primary estimand was the unadjusted within-member change in home SBP at 6 months among members with Stage-1 and Stage-2 blood pressure at baseline; a secondary estimand corrected for RTM using an ANCOVA linear mixed model with the at-goal stratum as an internal negative-control population. Among Stage-1 members (n = 34), unadjusted SBP change was -4.36 mmHg (95% CI -7.43 to -1.28; p = 0.0069), paired with an RTM-corrected secondary change of -3.33 mmHg (-6.40 to -0.26; p = 0.033). Among Stage-2 members (n = 53), unadjusted change was -10.17 mmHg (-12.94 to -7.40; p < 0.001), paired with an RTM-corrected secondary change of -5.50 mmHg (95% CI -8.50 to -2.50; p = 0.00037); RTM accounted for [~]24% and [~]46% of the unadjusted decline in Stage-1 and Stage-2, respectively. RTM-corrected estimates were robust to sensitivity analyses on measurement modality, seasonality, covariates and model specification, with no evidence of attrition bias. Program participation was associated with a decline in home SBP among Stage-1 and Stage-2 members that remained significant, though smaller, after RTM correction, supporting RTM-adjusted SBP change as the appropriate metric for evaluating food-as-medicine interventions.
Related
- Fertility in Ethiopia: factors associated with the number of live births -a survey-adjusted poisson regression analysis of the 2019 ethiopian mini demographic and health survey.
- Lifestyle Medicine in the 21st Century: Evidence-Based Strategies for Noncommunicable Disease Risk Reduction
- Recalculated HOMA-IR and Recorded Blood Pressure Changes in Treated Internal Medicine Patients: An Exploratory Retrospective Study
- Diabetes attenuates weight reduction-mediated liver fibrosis regression in persons with morbid obesity.
- Precision Medicine in Acute Coronary Syndromes: Integrating Plaque Phenotyping, Personalized Revascularization, Antithrombotic Strategies, and Residual Risk Reduction
BibTeX
@misc{pedroso2026blood,
title = {{Blood Pressure Reduction in Multiomic Digital Food-as-Medicine: a single-arm cohort study with a regression-to-the-mean-adjusted estimand}},
author = {I. Pedroso and S. V. Kumbhare and S. K. Saravanan and G. Sharma and D. E. Almonacid and R. Sinha},
howpublished = {medRxiv},
year = {2026},
month = sep,
doi = {10.64898/2026.09.24.26363892},
url = {https://www.medrxiv.org/content/10.64898/2026.09.24.26363892v1},
note = {CC BY-NC-ND},
}
RIS
TY - UNPB
TI - Blood Pressure Reduction in Multiomic Digital Food-as-Medicine: a single-arm cohort study with a regression-to-the-mean-adjusted estimand
AU - I. Pedroso
AU - S. V. Kumbhare
AU - S. K. Saravanan
AU - G. Sharma
AU - D. E. Almonacid
AU - R. Sinha
PY - 2026
DA - 2026/09/24
PB - medRxiv
DO - 10.64898/2026.09.24.26363892
UR - https://www.medrxiv.org/content/10.64898/2026.09.24.26363892v1
AB - 1Elevated systolic blood pressure (SBP) is a major modifiable driver of cardiovascular morbidity. Digital food-as-medicine and home-blood-pressure-monitoring programs increasingly support its management outside the clinic, but most published evaluations are single-arm, pre/post designs; because enrolment is conditioned on an elevated baseline reading, regression to the mean (RTM) is expected to inflate any observed improvement, and this is rarely checked against an internal comparator. We conducted a retrospective, single-arm cohort study of home blood-pressure monitoring within a commercial digital food-as-medicine program serving a US employer-sponsored population with obesity. Of 329 members included, 136 were at-goal (<130/80 mmHg), 74 at Stage 1 (130-134/80-84 mmHg) and 119 at Stage 2 ([≥]135/85 mmHg) at baseline; follow-up SBP was evaluable for 128, 68 and 112 members in these strata at 3 months and for 62, 34 and 53 at 6 months, respectively. The primary estimand was the unadjusted within-member change in home SBP at 6 months among members with Stage-1 and Stage-2 blood pressure at baseline; a secondary estimand corrected for RTM using an ANCOVA linear mixed model with the at-goal stratum as an internal negative-control population. Among Stage-1 members (n = 34), unadjusted SBP change was -4.36 mmHg (95% CI -7.43 to -1.28; p = 0.0069), paired with an RTM-corrected secondary change of -3.33 mmHg (-6.40 to -0.26; p = 0.033). Among Stage-2 members (n = 53), unadjusted change was -10.17 mmHg (-12.94 to -7.40; p < 0.001), paired with an RTM-corrected secondary change of -5.50 mmHg (95% CI -8.50 to -2.50; p = 0.00037); RTM accounted for [~]24% and [~]46% of the unadjusted decline in Stage-1 and Stage-2, respectively. RTM-corrected estimates were robust to sensitivity analyses on measurement modality, seasonality, covariates and model specification, with no evidence of attrition bias. Program participation was associated with a decline in home SBP among Stage-1 and Stage-2 members that remained significant, though smaller, after RTM correction, supporting RTM-adjusted SBP change as the appropriate metric for evaluating food-as-medicine interventions.
ER -