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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT05929469
Eligibility Criteria:
Inclusion Criteria:
* Current age: 18-65 years
* Lives in North Carolina
* Body mass index (BMI) of 27.5-45 kg/m\^2
* Ability to read, write, and speak English
* Ownership of iPhone with a data and texting plan
* Ability to commit to the required counseling sessions (0-5 sessions, based on randomization)
* Is not living a participant or staff member on this trial
* Willingness to be randomized to any of the treatment sequences
Exclusion Criteria:
* Weight loss of more than 10 pounds in the last 6 months that was maintained
* A history of weight loss surgery
* Pre-existing medical condition(s) that prevent them from adhering to a supervised exercise routine
* Have Type 1 Diabetes or are currently taking medicine for Type 2 Diabetes
* Have recently been diagnosed or treated for cancer
* Currently pregnant, pregnant within the past 6 months, or plan to become pregnant in the next 6 months
* Report taking prescription or over the counter medication with a known impact on metabolism or weight
* Report a history of an eating disorder
* History of psychotic disorder or bipolar disorder, or have been hospitalized for depression or other psychiatric disorder within the past 12 months
* History of alcohol or substance abuse
* Current participation in another weight loss program that may interfere with participation in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05929469
Study Brief:
Protocol Section:
NCT05929469