Clinical trial for Obesity & Overweight
Official title Trial of Food Is Medicine Approaches for Obesity Treatment in Adults With Food Insecurity
ClinicalTrials.gov ID: NCT07396805
What this study is testing
- What it's testing
- The study wants to find out whether giving participants either home‑delivered medically‑tailored groceries or grocery vouchers, together with a behavioral weight‑loss program, leads to greater weight loss and better quality of life than the program alone.
- Who it's for
- Adults who are obese and also have difficulty affording enough healthy food.
- What's involved
- Participants will follow a behavioral weight‑loss program and will be randomly assigned to receive either home‑delivered groceries, grocery vouchers, or no extra food assistance. They will have regular check‑ins and surveys about their health and diet.
- Time commitment
- The study runs for several months, with periodic visits for the weight‑loss program sessions and follow‑up assessments.
- Time commitment: about 52 weeks
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 18 and older
You may be able to join if
- BMI\>30 kg/m2
- Screening positive for food insecurity using the well-validated, 10-item US Adult Food Security Survey Module.
- Age 18 years and older
- Completion of baseline assessments
- Ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest)
You likely can't join if
- Significant psychiatric conditions (e.g., active substance abuse, schizophrenia) that may pose a risk to the participant during intervention, cause a...
- Pregnant or planning pregnancy in the next year
- Planned move from the Baltimore area in the next year
- Recently began a course of or changed the dosage of medication that can cause significant weight change (±5 kg)
- Previous or planned obesity treatment with surgery or a weight-loss device
- Weight loss of \>5 kg in the previous 90 days
See the full eligibility criteria
- BMI\>30 kg/m2
- Screening positive for food insecurity using the well-validated, 10-item US Adult Food Security Survey Module.
- Age 18 years and older
- Completion of baseline assessments
- Ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest)
- Willing and able to provide pictures of food receipts to study team (or mail receipts to study team)
- Willing and able to provide written informed consent and participate in all study activities
- Female participants of child-bearing potential must agree in writing to use an approved method of contraception during the study
- Significant psychiatric conditions (e.g., active substance abuse, schizophrenia) that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the program's...
- Pregnant or planning pregnancy in the next year
- Planned move from the Baltimore area in the next year
- Recently began a course of or changed the dosage of medication that can cause significant weight change (±5 kg)
- Previous or planned obesity treatment with surgery or a weight-loss device
- Weight loss of \>5 kg in the previous 90 days
- Household member already participating in study due to potential contamination effects
- Lack of stable residence and ability to store and prepare food
- Lack of telephone
- Severe food allergies
- Following a specialized dietary regimen (e.g., gluten-free)
The study team makes the final eligibility decision.
Where it is enrolling
- Baltimore, Maryland, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
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, so 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, but confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.