Enjoying Affordable and Tasty Food Together

NCT ID: NCT07036757

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-28
• Study Completion Date: 2026-07-30

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?

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.

Conditions

Food Insecurity; Dietary Quality; Quality of Life; Cooking Self-efficacy; Perceived Stress; Anxiety; Depressive Symptomatology; Anthropometrics: Height and Weight; Glucose Variability; Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Meal Kit and Nutrition Education arm

Receives the meal kit intervention and nutrition education education materials.

Group Type: EXPERIMENTAL

Meal Kit and Nutrition Education

Intervention Type: OTHER

Meal kits contain ingredients for 3 meals designed for 4 servings, along with nutrition education materials, recipes, and information on how to store and prepare the meals. Weekly educational content focused on healthy eating, food security, and meal planning will be provided, either via print materials or through an online platform (e.g., email or app-based resources).

Usual care

Receives standard of care, which will include printed materials from the Dietary Guidelines for Americans on eating a healthy diet and complementary recipes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Meal Kit and Nutrition Education

Meal kits contain ingredients for 3 meals designed for 4 servings, along with nutrition education materials, recipes, and information on how to store and prepare the meals. Weekly educational content focused on healthy eating, food security, and meal planning will be provided, either via print materials or through an online platform (e.g., email or app-based resources).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults aged 40 years and older.
• Household income at or less than the 200% the federal poverty level (household size 1: $30,120, household size 2: $40,880, household size 3: $51,640, household size 4: $62,400, and household size 5: $73,160)
• Willing to provide informed consent and complete the study requirements, including attending study visits and completing questionnaires.
• Access to a refrigerator or other means to safely store perishable food, as the meal kits require refrigeration.
• BMI > 30 kg/m2 and self-report having at least one of the following: elevated blood pressure or hypertension, elevated glucose, prediabetes or diabetes.
• Reside in the Greater Lowell area or surrounding regions to ensure feasibility of meal kit delivery and data collection.

Exclusion Criteria

• Less than 40 years old
• Does not have BMI >30 kg/m2, elevated blood pressure or hypertension, or elevated glucose, prediabetes or diabetes
• Not able to provide consent (adults lacking capacity)
• Follow a medically restricted diet or have allergies to wheat, soy, or dairy
• Plans to move from the Greater Lowell area within the next 12 months
• Live outside the Greater Lowell area because this will impact meal kit delivery
• Individuals without a working refrigerator in your household
• Have a serious medical condition requiring a doctor's care including cancer, chronic kidney disease and/or celiac disease
• Currently part of a study on diabetes, cardiovascular disease, nutrition or weight-loss
• Currently taking any weight loss medication like Ozempic, or medication for diabetes, dyslipidemia or hypertension
• Currently using a continuous glucose monitor

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BJ's Wholesale Club

UNKNOWN

Sponsor Role: collaborator

University of Massachusetts, Lowell

OTHER

Sponsor Role: lead

Responsible Party

Sabrina Noel

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sabrina Noel, PhD

Role: CONTACT

sabrina_noel@uml.edu

978 934 6459

Kelsey Mangano, PhD

Role: CONTACT

Kelsey_mangano@uml.edu

978 934 6367

Other Identifiers

IRB#24

Identifier Type: -

Identifier Source: org_study_id