Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT07036757
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT07036757
Study Brief:
Protocol Section:
NCT07036757