Enjoying Affordable and Tasty Food Together

NCT07036757 | Recruiting

• 1 other identifier: IRB#24
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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?

Conditions

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

Keywords

Nutrition Education; Cardiometabolic outcomes; Meal Kits; Stress and Mental Health; Quality of Life

Outcome Measures

Primary Outcomes (10)

• Food insecurity

  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.

  At enrollment and at 12 weeks

• Dietary Quality

  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).

  At enrollment and at 12 weeks

• Perceived Stress

  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.

  At enrollment and at 12 weeks

• Anxiety

  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.

  At enrollment and at 12 weeks

• Depressive Symptomatology

  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.

  At enrollment and at 12 weeks

• Health-related Quality of Life

  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.

  At enrollment and at 12 weeks

• Blood Pressure

  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.

  At enrollment and at 12 weeks

• Body Mass Index

  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.

  At enrollment and at 12 weeks

• Glucose variability

  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.

  At enrollment and at 12 weeks

• Waist circumference

  Waist circumference will be measured in duplicate using a flexible tape measure following standard procedures. An average of the two values will be used.

  At enrollment and 12 weeks.

Study Arms (2)

Meal Kit and Nutrition Education arm

EXPERIMENTAL

Receives the meal kit intervention and nutrition education education materials.

Other: Meal Kit and Nutrition Education

Usual care

NO INTERVENTION

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

Interventions

Meal Kit and Nutrition Education 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).

Meal Kit and Nutrition Education arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Lowell: lead

Study Sites (1)

University of Massachusetts Lowell

Lowell, Massachusetts, 01851, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Body Weight; Psychological Well-Being

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Sabrina Noel, PhD

CONTACT

978 934 6459; sabrina_noel@uml.edu

Kelsey Mangano, PhD

CONTACT

978 934 6367; Kelsey_mangano@uml.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: June 25, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)