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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT04848532
Eligibility Criteria:
Inclusion Criteria:
1. Are between 14 and 18 years of age
2. Have a BMI between the 85th and 99th percentiles for sex and age as determined by the CDC growth charts
3. Are currently living at home with a parent or guardian
4. Have at least one parent or guardian who is willing to participate in the study
5. Are willing to complete baseline assessment tasks
6. Have a smartphone, are willing to download an app to track food intake and complete surveys on the phone for two seven-day periods throughout the course of the study, and are willing to wear a fitness tracker during these same two week-long periods
7. Are located in the US and wiling/able to participate in remote intervention and assessments
Exclusion Criteria:
1. Acute suicide risk
2. Inability to engage in physical activity (defined as walking two city blocks without stopping)
3. Have diabetes or a history of bariatric surgery
4. Current medical or psychiatric condition that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to comply with the program (i.e., bulimia nervosa, substance abuse disorder, psychosis, bipolar I disorder, and/or any condition prohibiting physical activity)
5. Are pregnant or planning to become pregnant in the next 2 years
6. Recently began or changed the dose of a medication that can cause significant change in weight
7. Have experienced weight loss ≥ 5% in the previous 6 months
8. Are planning to begin in the next 16 months, or are currently participating in, another weight loss treatment or psychotherapy for binge eating and/or weight loss
9. Are engaging in compensatory vomiting, other severe compensatory behaviors, or more than 12 of any compensatory behaviors in the previous 3 months
10. Are currently taking medication (e.g., Contrave, Alli, etc.) which is specifically intended for weight loss
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
18 Years
Study:
NCT04848532
Study Brief:
Protocol Section:
NCT04848532