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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT05203718
Eligibility Criteria:
Inclusion Criteria:
1. ≥18 to 80 years of age
2. BMI ≥30.0 kg/m2
3. access to a computer or an iPhone/iPad or be willing to use a study loaner smart phone
Exclusion Criteria:
1. pregnant or breastfeeding or plan to become pregnant in the next 6 months, or who become pregnant during the study
2. taking any medication that may impact dietary intake and weight:
a. Immunosuppressants, steroids, medications for weight loss or to manage blood sugars or a psychiatric condition other than anxiety/depression
3. enrolled in another intervention that could influence dietary intake
4. have had bariatric surgery within the past 2 years
5. unwilling to delay bariatric surgery for the next 6 months
6. who have gained or loss more than 5.5 kg in the previous 3 months
7. unable to participate meaningfully in an intervention that involves using software available in English. The reason for this is that the food training apps have not been designed or validated in audio form or in other languages. (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia)
8. institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over diet), unwilling or inability to provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05203718
Study Brief:
Protocol Section:
NCT05203718