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:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT06800794
Eligibility Criteria:
Inclusion Criteria:
* Woman between the ages of 18-45.
* Premenopausal.
* Obese (BMI ≥ 30).
* Diagnosed with prediabetes (HbA1c: 5.7%-6.4%).
* Experiencing food insecurity (score of 2-6 on the six-item food insecurity questionnaire).
* Income below 300% of the household federal poverty threshold.
* Lives alone.
Exclusion Criteria:
* Actively planning to become pregnant (e.g., individuals trying to conceive or undergoing fertility treatment, based on self-report).
* Delivered a baby within the past 6 months (self-report).
* Non-ambulatory (e.g., individuals unable to walk independently or requiring a wheelchair for mobility).
* Intellectual impairment that would impact treatment adherence.
* Unmanaged mood disorders, substance use disorders, personality disorders, or a history of eating disorders, including:
* Generalized anxiety disorder.
* Depression.
* Alcohol dependence.
* Schizophrenia.
* Anorexia nervosa, bulimia, or binge eating disorder within the past 6 months.
* Recent weight loss exceeding 5% of body weight within the past 6 months (self-report).
* Food allergies to study-related foods, including dairy, soy, nuts, or gluten.
* History of bariatric surgery or GLP-1 agonist use (self-report).
* Inability to read or write in English (self-report).
* Planned relocation out of the study area during the study timeframe (self-report).
* Uncontrolled diabetes (HbA1c \> 9%) or hypertension (blood pressure \> 160/100 mmHg), based on self-report or screening visit measurements.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06800794
Study Brief:
Protocol Section:
NCT06800794