No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
6 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
120 (estimated)
Sponsor
Amrik Singh Khalsa · Other
Who this trial is looking for
This trial is looking for families with a parent who has a high BMI and a child between 6 to 11 years old. Participants will receive support to improve their heart health through access to healthy food, nutrition education, and coaching.
Are You a Good Fit for This Trial?
You may be able to join if
I am a parent or legal guardian of a child aged 6 to 11 years.
I am 18 years or older.
I have an eligible Medicaid insurance plan.
I can read and speak English fluently.
I have a BMI greater than 30.
I can consume fruits and vegetables without medication-nutrient concerns.
You may not be able to join if
I am not the legal guardian or primary caregiver.
I do not speak English.
I have active metabolic or digestive illnesses that affect nutrient absorption.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 healt…
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.
Trial Locations
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City
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Eligibility Criteria
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 ha…
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.).
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