HypertensionHeartWellNCT06358417
CHW Intervention to Improve Nutrition Security of Patients With Hypertension
A study testing Nutrition-enhanced CHW and Basic CHW in people with Hypertension and Nutrition, Healthy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Hypertension, Nutrition, Healthy, Food Insecurity
- What is being tested?
- Nutrition-enhanced CHW and Basic CHW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible to participate in the Massachusetts General Hospital CHW hypertension program (age 21 years or older, uncontrolled hypertension, patient at one of 5 participating primary care clinics; either identifies as a minoritized race/ethnicty or is low-income); speaks English or Spanish
Who cannot join
- declines participation in CHW hypertension program; does not speak English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: CHW Intervention to Improve Nutrition Security of Primary Care Patients With Hypertension
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.
Read the detailed description
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.
- Being tested
- Nutrition-enhanced CHW, Basic CHW
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition-enhanced CHWBehavioural
CHW provides nutrition education and skills training in addition to the usual care (Basic CHW) hypertension management.
Basic CHWBehavioural
CHW provide usual care for hypertension management.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nutrition-enhanced CHW |
| 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. Receives: Behavioral: Basic CHW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasiblity
Proportion of eligible participants enrolled in study
Measured: Baseline
Feasibility of CHW nutrition intervention (intervention arm only)
At least 70% participants complete at least 3 of 4 CHW nutrition education modules
Measured: 4 months
Acceptability (intervention arm only)
Average of participants' ratings of intervention components on a 10-point scale.
Measured: 4 months
Secondary outcomes (4)
Diet quality
Change in Healthy Eating Index-20 score
Measured: 4 months
Blood pressure
Change in systolic and diastolic blood presure
Measured: 4 months
Secondary feasibility (intervention arm only)
At least 70% participants complete 3 of 6 nutrition worksheets
Measured: 4 months
Secondary feasibility (intervention arm only)
At least 70% participants have a CHW assessment of their home cooking environment
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Sep 2024
- Primary completion26 Sep 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne N. Thorndike, MD, MPH, Massachusetts General Hospital
- Investigators
- Anne N Thorndike, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358417
- Sponsor's protocol ID
- 2024P000873
- Acronym
- HeartWell
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41610938
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHW Intervention to Improve Nutrition Security of Primary Care Patients With Hypertension
- ClinicalTrials.gov ID
- NCT06358417
- Acronym / sponsor ID
- HeartWell / 2024P000873
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition-enhanced CHW intervention | Experimental | Behavioral: Nutrition-enhanced CHWThis 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. |
| Basic CHW intervention | Active comparator | Behavioral: Basic CHWThe 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. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible to participate in the Massachusetts General Hospital CHW hypertension program (age 21 years or older, uncontrolled hypertension, patient at one of 5 participating primary care clinics; either identifies as a minoritized race/ethnicty or is low-income); speaks English or Spanish
Key exclusion criteria (1 listed)
- declines participation in CHW hypertension program; does not speak English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition-enhanced CHWCHW provides nutrition education and skills training in addition to the usual care (Basic CHW) hypertension management. | Behavioural | Nutrition-enhanced CHW intervention |
| Basic CHWCHW provide usual care for hypertension management. | Behavioural | Basic CHW intervention |
Primary outcome
Feasiblity
Time frame: Baseline
Proportion of eligible participants enrolled in study
Feasibility of CHW nutrition intervention (intervention arm only)
Time frame: 4 months
At least 70% participants complete at least 3 of 4 CHW nutrition education modules
Acceptability (intervention arm only)
Time frame: 4 months
Average of participants' ratings of intervention components on a 10-point scale.
4 secondary outcomes
Diet quality
Time frame: 4 months
Blood pressure
Time frame: 4 months
Secondary feasibility (intervention arm only)
Time frame: 4 months
Secondary feasibility (intervention arm only)
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Derived from this study: PubMed 41610938Gu 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne N Thorndike, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition-enhanced CHW and Basic CHW in people with Hypertension and Nutrition, Healthy, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasiblity (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06358417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.