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The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced community health worker (CHW) intervention for primary care patients with nutrition insecurity and poorly controlled hypertension. The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension (Basic CHW) program that provides hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months.
The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced CHW intervention in primary care patients with nutrition insecurity and poorly controlled hypertension. The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension (Basic CHW) that provides basic hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months. The CHW nutrition intervention curriculum is tailored to the needs and preferences of a food-insecure population with limited resources. Nutrition education materials will be provided to participants, including a booklet of nutrition information and a summarized version of key points on a brochure that they can use as a quick reference when grocery shopping. Nutrition education will focus on reducing sodium, saturated fats, and added sugars and increasing fruits, vegetables, and whole grains. Much of the educational material is based on a traffic-light system. These topics are organized into four modules: nutrition label reading, grocery shopping, meal-planning, and healthy cooking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition-enhanced CHW intervention | Experimental | This intervention integrates a nutrition component into the Basic CHW hypertension intervention to address gaps in patients' knowledge, skills, and resources for consuming and sustaining a healthful diet. CHWs will administer a 4-part nutrition curriculum that is tailored to the needs and preferences of a food-insecure population with limited resources. The nutrition education materials provided to participants will include a booklet of nutrition information that will serve as the primary educational resource for CHW use with participants. |
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| Basic CHW intervention | Active Comparator | The CHW provides basic hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring. All participants are provided home BP cuffs and remote monitoring free of charge. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition-enhanced CHW | Behavioral | CHW provides nutrition education and skills training in addition to the usual care (Basic CHW) hypertension management. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasiblity | Proportion of eligible participants enrolled in study | Baseline |
| Feasibility of CHW nutrition intervention (intervention arm only) | At least 70% participants complete at least 3 of 4 CHW nutrition education modules | 4 months |
| Acceptability (intervention arm only) | Average of participants' ratings of intervention components on a 10-point scale. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diet quality | Change in Healthy Eating Index-20 score | 4 months |
| Blood pressure | Change in systolic and diastolic blood presure | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne N Thorndike, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41610938 | Derived | Gu KD, Cheng J, Bejarano O, Gelsomin E, Malone A, Faulkner KC, Thorndike AN. Design of Heart Well: A randomized pilot study of a community health worker-delivered nutrition intervention for low-income adults with hypertension. Contemp Clin Trials. 2026 Mar;162:108244. doi: 10.1016/j.cct.2026.108244. Epub 2026 Jan 28. |
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De-identified feasiblity, acceptability, diet quality, and blood pressure data will be shared. The data and details related to the analytic plan and study measures will be deposited in a publicly accessible data repository, such as the Harvard Dataverse, a NIH-approved Scientific Generalist Data Repository free to researchers inside and outside the Harvard community.
Analytic plans and details will be made available no later than the official publication date of a peer-reviewed article that includes the study results, and these will be available for at least 5 years after the study period ends. De-identified data from the study will be made publicly available through the data repository within 90 days of the closeout of the project and made available according to the Harvard Dataverse's data retention policy.
In accordance with the data repository methods, completion of a data use agreement form, that stipulates data sharing under an IRB-approved protocol, will be required for accessing the data.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Basic CHW | Behavioral | CHW provide usual care for hypertension management. |
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| Secondary feasibility (intervention arm only) | At least 70% participants complete 3 of 6 nutrition worksheets | 4 months |
| Secondary feasibility (intervention arm only) | At least 70% participants have a CHW assessment of their home cooking environment | 4 months |