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 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT07027995
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of at least one of the following conditions: hypertension, type 2 diabetes, hyperlipidemia, chronic kidney disease, and/or metabolic syndrome.
* At least 18 years of age at the time of signing consent.
* Participants must have reliable transportation to attend Exercise is Medicine sessions.
* Access to an internet-enabled device.
* No objections to online grocery shopping, home food deliveries, or nutrition counseling.
* Residence meets Instacart delivery requirements (e.g., non-institutionalized).
* Participant is willing to use a personal credit card for Instacart back-up payments.
* Participants must speak English to be able to consent and engage in FIM and EIM programs.
* Participant has been clinically prescribed GLP-1RA's.
Exclusion Criteria:
* Conditions that impact digestion, metabolism, or food intake (e.g. surgical loss of esophagus, stomach, or colon, pancreatic dysfunction, bariatric surgery, brain surgery that alters cognition, etc.).
* Participants with uncontrolled mental illness disorders (e.g., schizophrenia, bipolar disorder, major depression, etc.) that are not well-managed or controlled through treatment, as determined by the study team.
* Familial history of certain cancers (e.g., multiple endocrine neoplasia, medullary thyroid carcinoma, etc.).
* Active digestive illnesses (i.e., Celiac disease, irritable bowel syndrome, chronic malabsorption).
* Comorbidities such as psychiatric or general illness that may put the subject at risk as determined by the investigator/s.
* Renal impairment, eGFR \< 60 ml/min/1.73m2
* Factor which, in the investigator's opinion, is likely to compromise the subject's ability to participate in the study.
* Recent participation (e.g., 3 months) in other behavioral nutrition trials or programs (i.e., bariatric programs, diabetes education programs).
* Currently pregnant or planning to become pregnant during the study.
* Participant is not willing to provide a urine, blood, or stool sample.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07027995
Study Brief:
Protocol Section:
NCT07027995