BridgeMD
New treatment option for Food Insecurity
Official title Enjoying Affordable and Tasty Food Together
ClinicalTrials.gov ID: NCT07036757
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join 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...
- 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...
You likely can't join 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lowell, Massachusetts, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lowell, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.