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
This trial accepts healthy volunteersQualifiers
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
Design model
Factorial
Treatments tested in this trial
Nutrition Education
BehavioralParticipants 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.
PRO-CVH
BehavioralPRO-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.
Healthy Conversation Skills
BehavioralHealthy 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
Medically tailored groceries/cooking classes
BehavioralParticipants 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.
Treatment groups
120 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Nutrition Education onlyActive comparator 1 intervention
Group B: Nutrition Education and Medically Tailored Groceries/Cooking ClassesExperimental treatment 2 interventions
Group C: Nutrition Education and PRO-CVHExperimental treatment 2 interventions
Group D: Nutrition Education and Healthy Conversational SkillsExperimental treatment 2 interventions
Group E: Nutrition Education, Healthy Conversational Skills, and Medically Tailored Groceries/Cooking ClassesExperimental treatment 3 interventions
Group F: Nutrition education, PRO-CVH, and medically tailored groceries/cooking classesExperimental treatment 3 interventions
Group G: Nutrition education, PRO-CVH, and Healthy Conversational Skills.Experimental treatment 3 interventions
Group H: All InterventionsExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Cardiovascular Health Behavior
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.
Time frame
pre-intervention and up to 8 weeks post-baseline2
Intention to Change and Motivation to Change Lifestyle Behaviors
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.
Time frame
pre-intervention and up to 8 weeks post-baseline3
Program Evaluation
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).
Time frame
up to 8 weeks post-baseline4
Qualitative Interviews
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.
Time frame
up to 8 weeks post-baselineSecondary outcomes
1
Perceived Benefits/Barriers of Change
Self-reported surveys to determine the perceived benefits and the perceived barriers to lifestyle change for themselves and their child.
Time frame
pre-intervention and up to 8 weeks post-baseline2
Heart Disease Knowledge
Self-reported survey to determine an individual's knowledge of heart disease for themselves.
Time frame
Pre-Intervention3
Adapted Risk Behavior Diagnosis (ARBD) Scale
A self-reported survey to assess perceived severity, perceived susceptibility, fear, anxiety, self-efficacy, and response efficacy with relation to parent and their perception of their child's future cardiovascular disease risk.
Time frame
pre-intervention and up to 8 weeks post-baseline4
Self-reported Cardiovascular Disease Risk Factors
Surveys to determine parent's and their child's CVD risk factors.
Time frame
Pre-InterventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
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