FoRKS Program for High Blood Pressure

(FoRKS Trial)

Overseen By Lyndsi R Moser, BA, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Dementia, Alzheimer, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

Duration: 16 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing if delivering healthy food and teaching cooking skills can help adults with high blood pressure and food insecurity. Participants will receive either their regular care or a program that provides food and cooking lessons. The goal is to see if these changes can improve their blood pressure and nutrition.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is the treatment generally safe for humans?

Varenicline, also known as Chantix or Champix, has been associated with some safety concerns, including potential neuropsychiatric symptoms like depression and suicidal thoughts, as well as a small risk of cardiovascular events. However, these risks are generally low, and the overall number of adverse events reported in studies is small. ^{1 2 3 4 5}

How does the FoRKS treatment for high blood pressure differ from other treatments?

The FoRKS treatment is unique because it combines food resources and kitchen skills to help manage high blood pressure, focusing on dietary changes and cooking confidence rather than medication. This approach is different from standard drug treatments, as it emphasizes lifestyle and nutritional education to support health. ^{6 7 8 9 10}

What data supports the effectiveness of the FoRKS Program for High Blood Pressure treatment?

Research on culinary medicine and food provision interventions suggests that programs focusing on nutrition education and cooking skills can improve health outcomes by encouraging healthier eating habits. These programs have shown promise in improving diet quality and health markers in conditions like diabetes, which may indirectly support the potential benefits of the FoRKS Program for managing high blood pressure. ^{11 12 13 14 15}

Who Is on the Research Team?

Richard Holden, PhD

Principal Investigator

Indiana University

Daniel O Clark, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 35-75 living in Marion County with stable housing, kitchen access, and high blood pressure. They must be independent in daily activities, experience food insecurity or receive SNAP benefits, have normal cognition, and not consume excessive alcohol.

Inclusion Criteria

I am between 35 and 75 years old.

Stable housing with independent access to kitchen, including functional stove or hotplate, oven, refrigerator, and freezer (self report)

You need to have a good memory and be able to answer simple questions.

Exclusion Criteria

Moving out of area during study timeline

You drink more than 8 alcoholic drinks a week if you are a woman, or more than 15 if you are a man.

I am not willing to use a touchscreen device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete a full baseline assessment including questionnaires, finger stick for A1c point-of-care testing, weight, and 24-hour ambulatory blood pressure before randomization

1 week

1 visit (in-person)

Treatment

Participants receive either Enhanced Usual Care (EUC) with a 5-week Hypertension Self-Management Education and Support (SMES) class or Food Resources & Kitchen Skills (FoRKS) with home-delivered ingredient kits and virtual cooking classes for 11 weeks

16 weeks

Weekly virtual classes

Follow-up

Participants are monitored for maintenance evaluation and effectiveness after treatment

8 weeks

Assessments at Week 24

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care (EUC)
• Food Resources & Kitchen Skills (FoRKS)

Trial Overview The study tests a home-delivered foods and kitchen skills program (FoRKS) against Enhanced Usual Care (EUC) to see their effects on blood pressure control, diabetes management (HbA1c), food security, and nutrition in adults with hypertension.

How Is the Trial Designed?

Group I: Food Resources & Kitchen Skills (FoRKS) Experimental Treatment 1 Intervention

Participants randomized to FoRKS will attend weekly HTN SMES classes separately from EUC participants. SMES classes will include the EUC curriculum stated above and an introduction to the upcoming FoRKS intervention. Following HTN SMES completion, FoRKS continues with home-delivered Mediterranean-style ingredient kits, food management lessons, and hands-on cooking classes in one's own kitchen. Classes are led by registered dietitians via Webex. Classes are held twice per week thru Week 12, then only once per week through Week 16.

Group II: Enhanced Usual Care (EUC) Active Control 1 Intervention

Participants randomized to EUC will have access to existing usual primary care services. They will also be enrolled in Hypertension Self-Management Education and Support (SMES) class ("Hypertension group"), which is an existing CDC-endorsed program offered at Eskenazi Health to provide information and skills for managing hypertension (HTN). Classes are led by registered dietitians via Webex.

Enhanced Usual Care (EUC) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Chantix for:

• Smoking cessation

Approved in European Union as Champix for:

• Smoking cessation

Approved in Canada as Champix for:

• Smoking cessation

Approved in United States as Tyrvaya for:

• Dry eye disease

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A systematic review of 10 studies on food provision programs for patients with type 2 diabetes or prediabetes showed that those including nutrition education consistently reduced HbA1c levels, indicating improved diabetes management.

Programs varied widely in their design and implementation, but those that incorporated nutrition education—covering topics like general nutrition and fruit/vegetable consumption—tended to yield better dietary quality and health outcomes compared to those without such education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education. Schier, HE., Chetty, KS., Garrity, K., et al.[2023]

Culinary medicine programs, which include teaching kitchens and gardens, have shown promising preliminary outcomes in improving health metrics like weight and cardiometabolic risk factors in pediatric patients dealing with obesity.

Participation in culinary medicine workshops has increased healthcare employees' confidence and knowledge in preparing whole plant-based meals, suggesting that such programs can enhance healthy lifestyle behaviors both in patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching Kitchens and Culinary Gardens as Integral Components of Healthcare Facilities Providing Whole Person Care: A Commentary. Fals, AM., Brennan, AM.[2023]

The vegetable-focused cooking skills and nutrition program significantly improved parental cooking confidence and healthy food preparation skills, with scores increasing from 4.0 to 4.4 and 3.6 to 3.9 out of 5, respectively.

Participants also reported increased vegetable variety and home availability, with parents' vegetable variety scores rising from 30 to 32 and home vegetable availability from 16 to 18 out of 35, indicating a positive impact on dietary habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacts of a Vegetable Cooking Skills Program Among Low-Income Parents and Children. Overcash, F., Ritter, A., Mann, T., et al.[2019]

A prescription (PRx) program in rural Eastern North Carolina provided patients with type 2 diabetes weekly home deliveries of fruits and vegetables, leading to high patient satisfaction and increased consumption of produce.

The program not only improved dietary habits but also significantly enhanced glycemic control, demonstrating the effectiveness of combining food access with nutrition education and culinary resources for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Evaluation of the Delivery-Based HEALED Produce Rx Program for Uninsured Patients With Diabetes in Rural Eastern North Carolina. Sastre, LR., Stroud, B., Smith, E., et al.[2023]

Community-based cooking skill interventions significantly boost adults' confidence in their cooking abilities, regardless of age or setting.

While these programs show some positive effects on increasing fruit and vegetable intake, the evidence is inconsistent, highlighting the need for better study designs and long-term evaluations to fully understand their impact on dietary habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Interventions to Improve Cooking Skills and Their Effects on Confidence and Eating Behaviour. Garcia, AL., Reardon, R., McDonald, M., et al.[2022]

In a study of 12,159 patients, varenicline was associated with reported neuropsychiatric events, particularly anxiety, but no significant increase in these events was found over time, suggesting that the drug's safety profile remains largely stable.

While 7-17% of neuropsychiatric events were attributed to varenicline by general practitioners, the analysis did not raise significant safety concerns, indicating that further investigation is needed to clarify the relationship between varenicline and anxiety symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. Buggy, Y., Cornelius, V., Fogg, C., et al.[2021]

Chantix (varenicline tartrate) was approved by the FDA in May 2006 as a smoking cessation aid for adults aged 18 and older.

The approval indicates that Chantix is considered a safe and effective option to help smokers quit, although the abstract does not provide specific efficacy data or study details.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The FDA approves new drug for smoking cessation. [2015]

In a study of 2,682 patients using varenicline for smoking cessation, nausea and vomiting were the most common reasons for discontinuation and the most frequently reported adverse drug reactions, highlighting the need for patient monitoring regarding gastrointestinal side effects.

While some psychiatric events were reported, including anxiety and depression, all cases of suicidal behavior involved patients with prior psychiatric conditions, suggesting that clinicians should closely monitor individuals with such histories when prescribing varenicline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and drug utilization profile of varenicline as used in general practice in England: interim results from a prescription-event monitoring study. Kasliwal, R., Wilton, LV., Shakir, SA.[2021]

In a meta-analysis of 7002 subjects from 15 clinical trials, varenicline showed a trend toward increased cardiovascular events (MACE) compared to placebo, but this increase was not statistically significant, indicating that the overall risk remains low.

The study found that only a small number of cardiovascular events occurred in both varenicline (0.31%) and placebo (0.21%) groups, suggesting that while there may be a slight increase in risk, varenicline's cardiovascular safety profile is generally favorable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular safety of varenicline: patient-level meta-analysis of randomized, blinded, placebo-controlled trials. Ware, JH., Vetrovec, GW., Miller, AB., et al.[2015]

In a study of 338 smokers using varenicline for smoking cessation, 45.9% reported at least one adverse event, with a notably higher incidence in women (51.5%) compared to men (40.5%).

The study identified 32 unexpected adverse events, including 19 psychiatric issues, raising concerns about the tolerability of varenicline and suggesting the need for further research on its safety profile and potential dosage adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Tolerability profile of varenicline in current medical practice]. Dupont, P., Gillet, C., Guerin, M., et al.[2016]

The Centre Médical de Forcilles (CMDF) has successfully provided home enteral nutrition (HEN) to 4,297 patients over 9 years, significantly improving the quality of life for 58.9% of patients, particularly those with severe conditions like head and neck cancers.

HEN not only offers a preferred alternative to hospitalization for 95.8% of patients but also demonstrates substantial cost savings, with a daily expense of 120.38 F, which is 95% less than traditional hospitalization costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Home enteral nutrition: functional partnership experience in the network of care of the Centre Médical de Forcilles, 1990-1999]. Vayre, P., Cabrit, R., Bernard, PF., et al.[2015]

In a study of 414 patients receiving Home Enteral Nutrition (HEN), over 75% showed improvement in their nutritional status after six months, indicating the efficacy of personalized nutritional assessments and educational programs.

Patients who received intermittent enteral nutrition experienced significantly fewer tolerance issues and diarrhea, suggesting that the method of delivery can impact the safety and comfort of HEN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of nutritional and educational support on home enteral nutrition. Madrid-Paredes, A., Leyva-Martínez, S., Ávila-Rubio, V., et al.[2023]

The guideline provides 61 evidence-based recommendations for home enteral nutrition (HEN), covering indications, contraindications, access devices, product recommendations, monitoring, and termination criteria, aimed at healthcare providers and patients.

Developed using systematic reviews and clinical trials, the guideline ensures that HEN is implemented safely and effectively, enhancing patient care in home settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ESPEN guideline on home enteral nutrition. Bischoff, SC., Austin, P., Boeykens, K., et al.[2021]

A pilot study involving seven participants (four patients and three caregivers) showed that a cooking class intervention improved dietary choices and cooking confidence among head and neck radiotherapy patients, despite a decline in taste sensation.

Participants reported increased preference for healthy foods and made positive dietary changes, such as choosing fresh produce and healthier cooking methods, indicating the potential effectiveness of culinary medicine interventions in supporting nutritional status in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Eat to Live"-Piloting a Culinary Medicine Program for Head & Neck Radiotherapy Patients. Allen-Winters, S., Wakefield, D., Gaudio, E., et al.[2021]

Home enteral nutrition (HEN) significantly improves nutritional status, as evidenced by increases in body mass index (BMI), lean body mass (LBM), and skeletal muscle mass in postoperative patients with esophageal cancer compared to a normal oral diet (NOD).

HEN also enhances quality of life by improving physical, role, and social functioning, while reducing fatigue and the incidence of postoperative pneumonia, making it a beneficial intervention after esophagectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home enteral nutrition for patients with esophageal cancer undergoing esophagectomy: A systematic review and meta-analysis. Zhang, C., Hu, LW., Qiang, Y., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Teaching Kitchens and Culinary Gardens as Integral Components of Healthcare Facilities Providing Whole Person Care: A Commentary. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Impacts of a Vegetable Cooking Skills Program Among Low-Income Parents and Children. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Development and Evaluation of the Delivery-Based HEALED Produce Rx Program for Uninsured Patients With Diabetes in Rural Eastern North Carolina. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Community Interventions to Improve Cooking Skills and Their Effects on Confidence and Eating Behaviour. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The FDA approves new drug for smoking cessation. [2015]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Safety and drug utilization profile of varenicline as used in general practice in England: interim results from a prescription-event monitoring study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular safety of varenicline: patient-level meta-analysis of randomized, blinded, placebo-controlled trials. [2015]

10. France pubmed.ncbi.nlm.nih.gov

[Tolerability profile of varenicline in current medical practice]. [2016]

11. Netherlands pubmed.ncbi.nlm.nih.gov

[Home enteral nutrition: functional partnership experience in the network of care of the Centre Médical de Forcilles, 1990-1999]. [2015]

12. Bangladesh pubmed.ncbi.nlm.nih.gov

Impact of nutritional and educational support on home enteral nutrition. [2023]

13. England pubmed.ncbi.nlm.nih.gov

ESPEN guideline on home enteral nutrition. [2021]

14. Germany pubmed.ncbi.nlm.nih.gov

"Eat to Live"-Piloting a Culinary Medicine Program for Head & Neck Radiotherapy Patients. [2021]

15. Switzerland pubmed.ncbi.nlm.nih.gov

Home enteral nutrition for patients with esophageal cancer undergoing esophagectomy: A systematic review and meta-analysis. [2022]