Recruiting

Meal Kit Intervention

Sponsor:

University of Massachusetts, Lowell

Code:

NCT07036757

Conditions

Food Insecurity

Dietary Quality

Quality of Life

Cooking Self-efficacy

Perceived Stress

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Meal Kit and Nutrition Education

Study Details

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

Study ID

NCT07036757

Start date

Feb 1, 2026

Status verified date

Apr, 2026

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Oct 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Meal Kit and Nutrition Education arm

Receives the meal kit intervention and nutrition education education materials.

no intervention: 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.

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).

Primary outcome measure

  • Food insecurity [ Time Frame: At enrollment and at 12 weeks ]
  • Dietary Quality [ Time Frame: At enrollment and at 12 weeks ]
  • Perceived Stress [ Time Frame: At enrollment and at 12 weeks ]
  • Anxiety [ Time Frame: At enrollment and at 12 weeks ]
  • Depressive Symptomatology [ Time Frame: At enrollment and at 12 weeks ]
  • Health-related Quality of Life [ Time Frame: At enrollment and at 12 weeks ]
  • Blood Pressure [ Time Frame: At enrollment and at 12 weeks ]
  • Body Mass Index [ Time Frame: At enrollment and at 12 weeks ]
  • Glucose variability [ Time Frame: At enrollment and at 12 weeks ]
  • Waist circumference [ Time Frame: At enrollment and 12 weeks. ]

Central Contacts and Locations

Central contacts

Sabrina Noel, PhD

978 934 6459sabrina_noel@uml.edu

Kelsey Mangano, PhD

978 934 6367Kelsey_mangano@uml.edu

Locations

University of Massachusetts Lowell

Recruiting

Lowell, Massachusetts, United States, 01851

Contacts

Sabrina Noel

978 934 6459sabrina_noel@uml.edu

Kelsey Mangano

kelsey_mangano@uml.edu

More Information

Sponsor

University of Massachusetts, Lowell

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Lowell on 2026-05-05.