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 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT02296034
Eligibility Criteria:
Inclusion Criteria:
* Obese (BMI \>95 percentile for age based on CDC growth charts)
* Willing to wear a CGM initially before and after the Bright Bodies program
* Willing to check fingersticks 3 times a day while wearing the CGM
* Willing to keep a food record before and after the Bright Bodies program
* Be in good general health without other acute or chronic illness that in the judgment of the investigator could interfere with the study or jeopardize subject safety
* Able to give consent (permission from parents and subject assent will be required)
* Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods
Exclusion Criteria:
* Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
* Prior participation in the Bright Bodies program.
* Diagnosis of diabetes
* Participation in a concurrent lifestyle modification (exercise/nutrition) program
* Use of any medications known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy
* Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
* Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
* Subjects and/or parents who are not proficient in speaking/understanding the English language
* Subjects who discontinue participation in the Bright Bodies program during the study period will be excluded from follow-up monitoring
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
16 Years
Study:
NCT02296034
Study Brief:
Protocol Section:
NCT02296034