Food InsecurityPROJECT EATTNCT07036757
Enjoying Affordable and Tasty Food Together
A study testing Meal Kit and Nutrition Education in people with Food Insecurity and Dietary Quality, run by University of Massachusetts, Lowell at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Food Insecurity, Dietary Quality, Quality of Life
- What is being tested?
- Meal Kit and Nutrition Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Massachusetts Lowell
Lowell, Massachusetts, 01851
Sabrina Noel, 978 934 6459, sabrina_noel@uml.edu
Kelsey Mangano, kelsey_mangano@uml.edu
About this study
Official title: PROJECT EATT: Enjoying Affordable and Tasty Food Together
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:
Read more
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?
Read the 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
- Being tested
- Meal Kit and Nutrition Education
- Keywords
- Nutrition Education, Cardiometabolic outcomes, Meal Kits, Stress and Mental Health, Quality of Life
- Medical subject headings
- Anxiety Disorders, Body Weight, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal Kit and Nutrition EducationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Meal Kit and Nutrition Education arm | Experimental | Receives the meal kit intervention and nutrition education education materials. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At enrollment and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Feb 2026
- Primary completion28 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Lowell
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabrina Noel, University of Massachusetts, Lowell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036757
- Sponsor's protocol ID
- IRB#24
- Acronym
- PROJECT EATT
- Status last verified
- Apr 2026
- First submitted
- 7 May 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROJECT EATT: Enjoying Affordable and Tasty Food Together
- ClinicalTrials.gov ID
- NCT07036757
- Acronym / sponsor ID
- PROJECT EATT / IRB#24
- Conditions
- Food Insecurity, Dietary Quality, Quality of Life, Cooking Self-efficacy, Perceived Stress, Anxiety
- Keywords
- Nutrition Education, Cardiometabolic outcomes, Meal Kits, Stress and Mental Health, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Massachusetts, LowellUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 28 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meal Kit and Nutrition Education arm | Experimental | Other: Meal Kit and Nutrition EducationReceives the meal kit intervention and nutrition education education materials. |
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal Kit and Nutrition EducationMeal 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). | Other | Meal Kit and Nutrition Education arm |
Primary outcome
Food insecurity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal Kit and Nutrition Education in people with Food Insecurity and Dietary Quality, run by University of Massachusetts, Lowell at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Noel, PhD (978 934 6459, sabrina_noel@uml.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food insecurity (time frame: At enrollment and at 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.