Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
Study NCT ID:
NCT07036757
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-05-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enjoying Affordable and Tasty Food Together
Sponsor:
University of Massachusetts, Lowell
Organization:
Study Overview
Official Title:
PROJECT EATT: Enjoying Affordable and Tasty Food Together
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROJECT EATT
Brief Summary:
The goal of this pilot study is to examine the feasibility of a novel meal kit and nutrition education intervention among adults aged 40 years and older, who are lower income, and to evaluate the preliminary impact of the meal kit and nutrition education intervention on food insecurity, dietary quality, mental health, quality of life and cardiovascular risk factors compared with general nutrition education materials in this population.
The main questions are:
What is the acceptability and satisfaction with the meal kits and nutrition education intervention?
What are the participation rates in the nutrition education program and the evaluation of the intervention?
What is the impact of the intervention on food insecurity, dietary quality and cooking and food preparation self-efficacy compared with general nutrition education materials?
What is the impact of the intervention of psychosocial health, quality of life and cardiometabolic outcomes compared with general nutrition education materials?
The main questions are:
What is the acceptability and satisfaction with the meal kits and nutrition education intervention?
What are the participation rates in the nutrition education program and the evaluation of the intervention?
What is the impact of the intervention on food insecurity, dietary quality and cooking and food preparation self-efficacy compared with general nutrition education materials?
What is the impact of the intervention of psychosocial health, quality of life and cardiometabolic outcomes compared with general nutrition education materials?
Detailed Description:
Food insecurity is a major risk factor for chronic health conditions through mechanisms such as poorer dietary quality and higher intake of processed foods due to high cost of healthier foods, poorer psychosocial health from increased stress and depression due to the worry of not having enough food, tradeoffs in spending and priorities to purchase food, and increased immune system activation and inflammation. Individuals who have lower income reported barriers to healthy eating beyond just access to healthy foods, including lack of time to prepare meals, insufficient nutrition knowledge, and limited cooking skills. Programs that reduce burden related to shopping, planning, and cooking time, and that do not solely provide food, may be more successful in reducing food insecurity and increasing dietary quality long term. Pre-made meals (ready to eat), tailored for specific diseases, have been shown to be beneficial for people living with health outcomes like diabetes. While pre-made meals designed for specific diseases can improve health outcomes,19-21 they do not address nutrition knowledge and cooking efficacy, which are important for developing long term behavior change. Meal kits are a growing area of food retail because they reduce challenges with meal planning and grocery shopping, but the majority of studies that have examined meal kits in relation to outcomes do not include nutrition education, particularly focused on cultural relevance.
The proposed pilot study is a randomized trial to evaluate the feasibility and whether a meal kit and nutrition education program leads to greater improvements in food insecurity, dietary quality, cooking and food preparation self-efficacy, psychosocial outcomes, quality of life, and cardiometabolic outcomes (glucose variability, blood pressure and anthropometric measures) compared with printed nutrition education materials and complementary recipes.
After successful screening and consent, 120 participants will be randomly assigned to either:
Group 1 (Intervention group, n=60): Receives the meal kit intervention and nutrition education weekly for 12 weeks. The meal kits, which include all ingredients needed to make a meal and step-by-step instructions for making the meal, will be delivered to participants homes. Participants will received meal kits to make 3 meals per week containing up to 4-5 servings for families.
Group 2 (Control group, n=60): Receives standard of care, which will include printed materials on eating a healthy diet and complementary recipes weekly.
Assessments will occur at baseline and 12-week follow up.
The proposed pilot study is a randomized trial to evaluate the feasibility and whether a meal kit and nutrition education program leads to greater improvements in food insecurity, dietary quality, cooking and food preparation self-efficacy, psychosocial outcomes, quality of life, and cardiometabolic outcomes (glucose variability, blood pressure and anthropometric measures) compared with printed nutrition education materials and complementary recipes.
After successful screening and consent, 120 participants will be randomly assigned to either:
Group 1 (Intervention group, n=60): Receives the meal kit intervention and nutrition education weekly for 12 weeks. The meal kits, which include all ingredients needed to make a meal and step-by-step instructions for making the meal, will be delivered to participants homes. Participants will received meal kits to make 3 meals per week containing up to 4-5 servings for families.
Group 2 (Control group, n=60): Receives standard of care, which will include printed materials on eating a healthy diet and complementary recipes weekly.
Assessments will occur at baseline and 12-week follow up.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: