Enjoying Affordable and Tasty Food Together

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07036757
• Lead Sponsor: University of Massachusetts, Lowell

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.

Study Timeline

• Study First Submitted: 2025-05-07
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Study Start: 2025-09-28
• Primary Completion: 2026-02-28
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Food insecurity	At enrollment and at 12 weeks	The U.S. Department of Agriculture (USDA) 10-item food security screener will be used. This tool asks participants about their food security within the last 12 months. Scores range from 0 to 10, which a score of 0 indicating high food security, 1-2 indicating marginal food security, 3-5 indicating low food security, and 6-10 indicating very low food security.
Dietary Quality	At enrollment and at 12 weeks	Dietary data will be collected by three 24-hr dietary recalls, using multi-pass interview software. At each time point, one 24-hour recall will be conducted during the interview, and two by phone within the following week (including a weekend day). A trained interviewer will use the Nutrition Data System for Research software (NDSR version 2019; Nutrition Coordinating Center, University of Minnesota).
Perceived Stress	At enrollment and at 12 weeks	Perceived Stress Scale: The 14- item Perceived Stress Scale (PSS) gauges the respondent's perception of stress over the last month. The PSS measures the extent to which respondents perceive their lives over the past month as unpredictable and uncontrollable. Total scores ranges from 0-56, with higher scores indicating greater perceived stress.
Anxiety	At enrollment and at 12 weeks	The State Trait Anxiety Scale assesses anxiety in participants using a 10-item questionnaire. Total scores range from 10 to 40, with greater scores indicating greater anxiety symptoms.
Depressive Symptomatology	At enrollment and at 12 weeks	The Center for Epidemiological Studies Depression Scale (CES-D) will be used to assess depressive symptomatology. The scale consists of 20 items which ask about mood during the past week. Total scores range from 0 to 60, with higher scores indicating more severe depressive symptomatology.
Health-related Quality of Life	At enrollment and at 12 weeks	Health-related QOL will be assessed using the validated U.S. Centers for Disease Control and Prevention (CDC) Health-Related Quality of Life (HRQOL) scale. This instrument includes the standard 4-item set of Healthy Days core questions. Scores range from 0 to 30 days with higher scores indicating more frequent poor physical and mental health.
Blood Pressure	At enrollment and at 12 weeks	Systolic and diastolic blood pressure will be measured using an electronic sphygmomanometer (DinamapTM Model 8260, Critikon, Tampa, FL), in duplicate, after a short rest period.
Body Mass Index	At enrollment and at 12 weeks	Height and weight will be measured in duplicate following standard techniques and integrated into one reported measures of body mass index. Weight will be measured with a clinical scale (Toledo Weight Plate, Model I5S, Bay State and Systems Inc. Burlington, MA), and height with a portable stadiometer. Body mass index (BMI, kg/m2) will be calculated as weight in kilograms divided by height in meters squared.
Glucose variability	At enrollment and at 12 weeks	Interstitial glucose will be measured every 15 minutes using Dexcom G6 PRO continuous glucose monitors. Monitors will be fitted by trained research study staff on the upper, non-dominant arm with adhesive tape during the baseline visit and work for 7 days. The monitor will be removed by trained staff.
Waist circumference	At enrollment and 12 weeks.	Waist circumference will be measured in duplicate using a flexible tape measure following standard procedures. An average of the two values will be used.