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 @ 1:14 PM
Ignite Modification Date:
2025-12-24 @ 1:14 PM
NCT ID:
NCT04871295
Eligibility Criteria:
Inclusion Criteria:
* Able to understand and provide informed consent
* 18-65 years old
* Self-report of good health (physical and mental)
* Not diagnosed with diabetes
* Overweight or obesity (BMI ≥ 25)
* Able to meet our criteria of adherence to the program (at least 1 engagement per week on one of the following: logged exercise, logged meals, steps, weigh-ins, coach messages, read articles, and days with at least one weigh-in.)
* For females
* Not within the 6 months postpartum time frame
* Not planning to become pregnant in the next 5 months.
Exclusion Criteria:
* Inability or unwillingness of a participant to give written informed consent
* Currently taking medication which affects sleep or heart rate (e.g., (i) central nervous system stimulants, (ii) respiratory medications, (iii) antihistamines, (iv) central acting hormones (e.g. corticosteroids, thyroid), (v) high-dose anticholinergics, (vi) and cannot be using the maximum recommended dose for antihypertensive medications or use of multiple antihypertensive medications)
* Current diagnosed mental health condition (except mild anxious or depressive symptoms)
* Current diagnosed sleep disorder or condition not related to obesity (e.g., narcolepsy)
* Currently pregnant or ≤ 6 months postpartum
* Currently participating in shift work and/or have travelled between time zones in the last month
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the quality of the data; E.g., evidence of an eating disorder, major chronic condition
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04871295
Study Brief:
Protocol Section:
NCT04871295