224 Participants Needed

Medically-tailored Meals for Hypertension

(SMART Trial)

RS
Overseen ByRebecca Stone, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
Must be taking: Blood pressure medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to assist people with high blood pressure who struggle to access enough healthy food. It will test various methods, including home-delivered medically-tailored meals (MTM), community health worker support, and resource information, to determine which helps individuals adhere to their treatment and improve blood pressure. Suitable candidates for this trial include those with high blood pressure who are on medication, face challenges in obtaining nutritious food, and have recently visited their primary care doctor. As an unphased trial, this study provides a unique opportunity to explore innovative solutions for managing high blood pressure and improving access to nutritious food.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it involves people already prescribed blood pressure medications, it seems likely you can continue them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that meals designed for medical needs are generally safe and can improve health. For example, one study found that recipients of these meals had better nutrition and fewer instances of low blood sugar. Another study demonstrated that these meal programs benefit people with serious illnesses. Dietitians plan these meals to help manage conditions like high blood pressure.

Community health worker support is also safe and effective. Studies have shown that when community health workers assist, people better control their blood pressure. This support helps individuals manage high blood pressure and leads to improved health.

Both treatments in this trial—meals designed for medical needs and support from community health workers—are supported by research showing they are safe and effective.12345

Why are researchers excited about this trial?

Researchers are excited about medically-tailored meals (MTM) for hypertension because they offer a personalized dietary approach that could directly impact blood pressure management. Unlike standard treatments like medications and lifestyle changes, MTM delivers weekly meals specifically designed by dietitians based on the DASH diet, which has been shown to lower blood pressure. Additionally, the involvement of community health workers (CHWs) provides personalized support, helping participants overcome barriers in managing their condition. This holistic approach, combining tailored nutrition with community support, sets it apart from typical hypertension treatments.

What evidence suggests that this trial's treatments could be effective for hypertension?

This trial will compare the effects of different interventions on hypertension management. Participants in one arm will receive Medically-tailored Meals (MTM), which research has shown can improve health for people with certain illnesses. One study found that people following a diet similar to MTM, called the DASH diet, experienced a greater drop in their top blood pressure number by 5.7 points compared to those managing their diet independently. However, another study found no significant change in blood pressure after 12 weeks of using MTM.

Another arm will involve assistance from Community Health Workers (CHWs). Research indicates that CHWs can greatly improve blood pressure control. Specifically, one study showed that 68.2% of people working with CHWs had better blood pressure control compared to 41.6% in a group without this help.

The third arm will provide participants with resource information. While these tools don't directly lower blood pressure, they offer valuable support, such as connecting people to local food resources, which can help manage high blood pressure.24678

Who Is on the Research Team?

DP

Deepak Palakshappa, MD, MSHP

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for US residents with hypertension who struggle to secure enough food. Participants should be experiencing food insecurity and have a history of poor adherence to treatments due to this issue. Specific eligibility details are not provided, so general inclusion based on the condition and social situation applies.

Inclusion Criteria

Seen by their primary care doctor in the past 6 months
I have been diagnosed with high blood pressure.
Past 2 blood pressures at their primary care doctor were greater than 130/80mmHg
See 3 more

Exclusion Criteria

Systolic Blood Pressure > 210mmHg or a diastolic blood pressure > 120mmHg
Planning on moving out of the area within 6 months
Lack safe stable housing
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

First-stage Treatment

Participants are randomized to receive either information about community resources or in-person CHW support for 3 months

12 weeks
Bi-weekly follow-ups with CHW

Second-stage Treatment

Participants not responding to the first-stage treatment are re-randomized to receive either CHW support or home delivery of medically tailored meals for an additional 3 months

12 weeks
Weekly meal deliveries for MTM group

Follow-up

Participants are monitored for changes in adherence, blood pressure, and other health outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Community Health Worker (CHW) assistance
  • Medically-tailored Meals (MTM)
  • Resource information
Trial Overview The study tests if Medically-tailored Meals (MTM), Resource information, or Community Health Worker (CHW) assistance can improve treatment adherence and blood pressure in hypertensive patients facing food insecurity. It's an adaptive trial that changes interventions based on initial responses.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Resource informationExperimental Treatment1 Intervention
Group II: Medically-tailored Meals (MTM)Experimental Treatment1 Intervention
Group III: Community Health Worker (CHW) assistanceExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Approaches and outcomes of community health worker's ...Summarised outcomes of individual studies showed CHW enhanced the control and management of hypertension. Further studies are needed to indicate ...
Community Health Workers as Key Allies in the Global ...After 6 months at trial completion, BP control was superior in the CHW intervention (68.2%, n=154) compared with control (41.6%, n=137) group (P ...
Community Health Worker Led Hypertension Prevention ...So, the CHW program can have the highest impact by reaching a wider community to improve HTN awareness, treatment and control. Second reason is feasibility and ...
The important gap community health workers and care ...Compared to people receiving enhanced standard of care, people in these two groups made greater progress in lowering blood pressure. People in ...
Outcomes of the Pharmacist and Community Health Worker ...This study highlights the effectiveness of a pharmacist-CHW cardiovascular clinic model in significantly improving blood pressure outcomes over ...
A Community Health Worker–Led Intervention to Improve ...The adjusted odds of controlled BP (< 140/90 mmHg) for the treatment group were significant compared with the control group (odds ratio = 1.4; 95% confidence ...
Abstract 4143784: Long-Term Effectiveness of a ...Community health worker (CHW)-led intervention has been effective in lowering blood pressure (BP) and CVD risk. However, the long-term ...
The Role of CHWs in Addressing Hypertension4 CHWs are uniquely qualified to support individuals with hypertension; CHW interventions are known to improve health outcomes among individuals diagnosed with ...
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