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 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT03564392
Eligibility Criteria:
Inclusion Criteria:
* Has undergone any type of weight loss surgery at least 1.5 years ago
* Demonstrate ≥ 10% weight regain of maximum weight loss or 5% of their minimum weight post-surgery, with weight regain lasting for at least 3 months prior to enrollment.
* Ability to give consent and speak, write, and understand English.
Exclusion Criteria:
* Currently enrolled in structured weight loss program
* Currently pregnant/plan to become pregnant within 6 months of enrollment
* Have a serious medical condition that has the potential of affecting weight or that would prevent engagement in dietary changes and/or an exercise regimen
* Exhibit psychiatric symptoms that would interfere with the ability to benefit from the intervention, or report acute suicidality
* Non-ambulatory (i.e., unable to walk at least one city block without a cane or walker at the time of screening
* Use of medications known to affect body weight, such as chronic systemic steroids or psychiatric medications including lithium, tricyclic antidepressants, and antipsychotic agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03564392
Study Brief:
Protocol Section:
NCT03564392