NCT07380243 · Amrik Singh Khalsa
Pathways to Prevention Food-is-Medicine Trial
(P2P)
What this study is about
The goal of this study is to learn whether combining healthy food access with personalized tools can help families improve heart health and make lasting lifestyle changes.
View original scientific description
The goal of this study is to learn whether combining healthy food access with personalized tools can help families improve heart health and make lasting lifestyle changes. The main questions the study aims to answer are: * Do the new tools (PRO-CVH and Triple-C) help families improve their heart health? * Which combination of tools and supports works best for families with limited access to healthy food? * Is this type of program easy to carry out and acceptable to families and healthcare teams? Families in the study will include one parent with a BMI greater than 30 who has Medicaid insurance and their child aged 6 to 11 years. Depending on which group they are assigned to, families may: * Receive food and nutrition education via handouts and/or online curriculum * Have access to an online health assessment tool than can help you understand your/your child's risk factors for heart disease * Work with a personalized health coach who can help you set goals for healthier living online/virtually. * Receive medically tailored groceries and cooking classes. Researchers will follow participants for several months to see how their heart health changes and which parts of the program work best together. The information from this study will help design a larger clinical trial to test a practical, cost-effective program that can help families build healthier habits and reduce their risk of heart disease.
Interventions
BEHAVIORAL
Nutrition Education
Participants will receive handouts and access to an online curriculum for nutrition education. This education will be based on the Great Garden Detective Adventure (GDA) Team Nutrition, a USDA-supported Team Nutrition program that supports the United States Department of Agriculture (USDA) MyPlate guidelines and United States Dietary Guidelines. Educational content includes: increasing fruits and vegetables, improving whole grain intake, increasing water intake and limiting sugar-sweetened and high-fat beverages, selecting lean proteins, limiting sweets, and incorporating 60 minutes of physical activity per day.
BEHAVIORAL
PRO-CVH
PRO-CVH is the name of a cardiovascular health assessment and risk communication using a personalized, visual, and health-literacy friendly method. This web-based application is interactive and will assess and communicate cardiovascular health based on participant responses to surveys. The surveys will assess participant cardiovascular health indices based on the American Heart Association's Life's Essential 8 framework, behavioral components to change (e.g., motivation) and environmental barriers.
BEHAVIORAL
Healthy Conversation Skills
Healthy Conversation Skills are a behavioral intervention where health coaches and participants engage in conversations that promote change, supporting the client's autonomy in the change process, and goal-setting skills
BEHAVIORAL
Medically tailored groceries/cooking classes
Participants will receive funds for an online shopping cart, which will be tailored to promote a Mediterranean diet for cardiovascular health. Participants will attend cooking classes that use these foods. Classes are a skills-based training in home-cooked meals to educate parents on creating healthy meals on a budget. The curriculum consists of weekly classes by a Land Grant Extension Specialist. Each class includes nutrition education, hands-on cooking experience, and health promoting activities.
Primary outcome measures
Cardiovascular Health Behavior
Time frame: pre-intervention and up to 8 weeks post-baseline
A questionnaire will use participant responses to short-answer questions regarding lifestyle and dietary behaviors, physical activity, sleep, biological metrics, and nicotine exposure. The responses to this standardized questionnaire will result in a single composite score.
Intention to Change and Motivation to Change Lifestyle Behaviors
Time frame: pre-intervention and up to 8 weeks post-baseline
Self-reported survey to assess parent's intention to change their own and their child's lifestyle behaviors that put them at risk for future CVD.
Program Evaluation
Time frame: up to 8 weeks post-baseline
Survey to evaluate participant satisfaction with the intervention. The survey uses a 5-point Likert scale. There will be a series of statements and participants will select one of 5 responses ranging from 1 (completely disagree) to 5 (completely agree).
Qualitative Interviews
Time frame: up to 8 weeks post-baseline
Interviews with participants to assess participant thoughts on the intervention. Interviews will be analyzed qualitatively to learn about their experience with the intervention. Focus will be given to participant satisfaction.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Parent or legal guardian of school-aged child (ages 6 - 11 years of age)
- Parent/legal guardian is 18 years or older and the primary caregiver at home
- Parent and/or child has an eligible Medicaid insurance plan
- Parent is able to read and speak English fluently
- Parent has BMI greater than 30 kg/m/m
- Ability to consume fruits and vegetables without concerns of any medication-nutrient interactions (for example, warfarin)
Exclusion criteria
- Parent not a legal guardian or the primary caregiver
- Non-English speakers
- Parent or child is diagnosed with active metabolic or digestive illnesses that may result in nutrient malabsorption (Crohn's disease, Celiac, irritable bowel syndrome, food allergies, etc.).
Where
- Columbus, Ohio
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), American Heart Association, Ohio State University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 15, 2026 · Source of record for eligibility and locations