TY - JOUR
AU - K. D. Gu
AU - J. Cheng
AU - O. Bejarano
AU - E. Gelsomin
AU - A. Malone
AU - K. C. Faulkner
AU - A. N. Thorndike
A1 - 
AB - BACKGROUND: Suboptimal diet and food insecurity contribute to hypertension disparities experienced by individuals with low-income. Clinic-based nutrition counseling is limited by time constraints and low access to dietitians. Integrating community health workers (CHWs) with basic nutrition training into care teams may be an effective strategy to promote sustainable dietary modifications. OBJECTIVE: Describe the design of Heart Well, a study to determine whether adding nutrition counseling to a primary care-based CHW hypertension program is feasible and acceptable and improves diet and blood pressure (BP). METHODS: Heart Well is a 4-month randomized controlled study of low-income adults (N = 60) who have uncontrolled hypertension and are enrolled in a CHW hypertension coaching program. The control group receives usual care in the existing hypertension program. The intervention group additionally receives nutrition counseling on label reading, healthy eating on a budget, and simplified nutrition education (e.g., traffic light categories, green = healthy). Intervention CHWs are trained by a registered dietitian, who also provides ongoing CHW support. Primary outcomes are feasibility (i.e., proportion of participants enrolled, percent completion of nutrition modules) and acceptability (i.e., participant ratings of nutrition components). Secondary outcomes are changes over 4 months in Healthy Eating Index-2020 scores (calculated from dietary recalls) and in BP. CONCLUSIONS: Heart Well tests a novel strategy integrating nutrition counseling tailored to low-income adults into an existing CHW hypertension program. Results will inform a larger trial to evaluate the intervention's impact on cardiovascular health and may have implications for CHW interventions for other diet-sensitive chronic diseases. TRIAL REGISTRATION: ClinicalTrials.govNCT06358417.
AD - Division of Endocrinology, Massachusetts General Hospital, 50 Staniford St. Suite 340, Boston, MA 02114, United States of America; Harvard Medical School, 25 Shattuck Stree, Boston, MA 02115, United States of America. Electronic address: kristine.gu@ucsf.edu.; Division of General Internal Medicine, Massachusetts General Hospital, 100 Cambridge St. Suite 1600, Boston, MA, United States of America; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, United States of America.; Division of General Internal Medicine, Massachusetts General Hospital, 100 Cambridge St. Suite 1600, Boston, MA, United States of America.; Department of Nutrition and Food Services, Massachusetts General Hospital, 165 Cambridge Street, Suite 402, Boston, MA 02128, United States of America.; Harvard Medical School, 25 Shattuck Stree, Boston, MA 02115, United States of America; Division of General Internal Medicine, Massachusetts General Hospital, 100 Cambridge St. Suite 1600, Boston, MA, United States of America.
AN - 41610938
BT - Contemp Clin Trials
C5 - Healthcare Disparities; Education & Workforce
DA - Mar
DO - 10.1016/j.cct.2026.108244
DP - NLM
ET - 20260128
JF - Contemp Clin Trials
LA - eng
N2 - BACKGROUND: Suboptimal diet and food insecurity contribute to hypertension disparities experienced by individuals with low-income. Clinic-based nutrition counseling is limited by time constraints and low access to dietitians. Integrating community health workers (CHWs) with basic nutrition training into care teams may be an effective strategy to promote sustainable dietary modifications. OBJECTIVE: Describe the design of Heart Well, a study to determine whether adding nutrition counseling to a primary care-based CHW hypertension program is feasible and acceptable and improves diet and blood pressure (BP). METHODS: Heart Well is a 4-month randomized controlled study of low-income adults (N = 60) who have uncontrolled hypertension and are enrolled in a CHW hypertension coaching program. The control group receives usual care in the existing hypertension program. The intervention group additionally receives nutrition counseling on label reading, healthy eating on a budget, and simplified nutrition education (e.g., traffic light categories, green = healthy). Intervention CHWs are trained by a registered dietitian, who also provides ongoing CHW support. Primary outcomes are feasibility (i.e., proportion of participants enrolled, percent completion of nutrition modules) and acceptability (i.e., participant ratings of nutrition components). Secondary outcomes are changes over 4 months in Healthy Eating Index-2020 scores (calculated from dietary recalls) and in BP. CONCLUSIONS: Heart Well tests a novel strategy integrating nutrition counseling tailored to low-income adults into an existing CHW hypertension program. Results will inform a larger trial to evaluate the intervention's impact on cardiovascular health and may have implications for CHW interventions for other diet-sensitive chronic diseases. TRIAL REGISTRATION: ClinicalTrials.govNCT06358417.
PY - 2026
SN - 1551-7144
SP - 108244
ST - Design of Heart Well: A randomized pilot study of a community health worker-delivered nutrition intervention for low-income adults with hypertension
T1 - Design of Heart Well: A randomized pilot study of a community health worker-delivered nutrition intervention for low-income adults with hypertension
T2 - Contemp Clin Trials
TI - Design of Heart Well: A randomized pilot study of a community health worker-delivered nutrition intervention for low-income adults with hypertension
U1 - Healthcare Disparities; Education & Workforce
U3 - 10.1016/j.cct.2026.108244
VL - 162
VO - 1551-7144
Y1 - 2026
ER -