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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07396805
Eligibility Criteria:
Inclusion 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
Exclusion Criteria:
* 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 behavioral recommendations
* 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07396805
Study Brief:
Protocol Section:
NCT07396805