Pathways to Prevention Food-is-Medicine Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorAmrik Singh Khalsa
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.).
Trial design
Treatments tested in this trial
- Nutrition Education
- PRO-CVH
- Healthy Conversation Skills
- Medically tailored groceries/cooking classes
Treatment groups
120 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Locations
1Nationwide Children's Hospital43205, ColumbusOhio, United States
Sponsors and collaborators
Amrik Singh Khalsa
Lead sponsor
Nationwide Children's Hospital
Sponsor institution
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
American Heart Association
Collaborator
Ohio State University
Collaborator
Source ClinicalTrials.gov