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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT03840733
Eligibility Criteria:
Inclusion Criteria:
* Previous enrollment in standard behavioral weight loss intervention (NCT01985568 or NCT03411356)
* Age 20-60 (This age range has been selected based upon the participants enrolled in the Parent Trial)
* Capable and willing to give informed consent
* Possess a smartphone to install and utilize the meal timing application
* Capable and willing to wear the Actigraph, ActivPAL and Actiwatch-2 for 24 hours/day for 28 consecutive days
* Willing to complete the Total Daily Energy Expenditure (TDEE) assessment which includes multiple urine collections and drinking stable water isotopes
Exclusion Criteria:
* Being considered unsafe to participate as determined by the study physician (Dr. Catennaci)
* New diagnosis of a medical condition (not observed in the Parent Trial) which may affect weight or energy metabolism (e.g. depression, CVD, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases)
* Women who became pregnant after completing the Parent Trial
* Current use or use within the last 6 months of prescription or over-the-counter medications known to affect appetite, weight, and sleep
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03840733
Study Brief:
Protocol Section:
NCT03840733