Enjoying Affordable and Tasty Food Together
Recruiting · NCT07036757 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Massachusetts, Lowell
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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?
Who can take part
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
Where it is running
1 location listed across 1 US state.
- University of Massachusetts Lowell - Lowell, Massachusetts, United States