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:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
NCT ID:
NCT01188616
Eligibility Criteria:
Inclusion Criteria:
* Children will be enrolled in the study if they meet a set of eligibility criteria which includes:
1. 0-3 BMI points above the 95th %ile for age and gender
2. age 9-12 years old
3. a PCP at BMC
4. an English speaking child and parent (based on interviewer assessment).
Exclusion Criteria:
* Children will be considered ineligible for the study if they:
1. have a health condition for which dietary recommendations in TLC-HEAT would be contraindicated
2. have cognitive impairment (not in a mainstream academic class in school)
3. have a terminal illness, current or former diagnosis of an eating disorder, or other diagnosis that the PCP deems should exclude them from participation
4. plan to move away from the Boston area in less than 12 months
5. are participating in another clinical weight treatment program.
* Initial screening will be done by research assistants over the phone.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Maximum Age:
12 Years
Study:
NCT01188616
Study Brief:
Protocol Section:
NCT01188616