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 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT01195012
Eligibility Criteria:
Inclusion Criteria:
* 1\) Child: Healthy 5 to 8 year old child who is overweight (BMI =/\>85%), but not morbidly obese (BMI\<99%)
* 2\) Child attends one of 4 TCPA clinics
* 3\) Child is Texas Children's Health Plan member/participant
* 4\) Parent who is child's primary care taker able and willing to participate
* 5\) Parent and child willing to attend and participate in 6 month intervention sessions and 3 measurement time points over 14 months
* 6\) Only one child per family will be eligible to participate.
Exclusion Criteria:
* 1\) Parent unable to read or write in English or Spanish.
* 2\) Parent or child unable to participate in counseling sessions in English or Spanish
* 3\) Child with BMI =/\> 99%tile
* 4\) Child with medical consequences of obesity (such as hypertension, hypercholesterolemia, insulin resistance, type 2 diabetes) that would require treatment and not prevention.
* 5\) Child on medications (such as oral steroids, stimulants, or anti-psychotic medications) that can affect their weight status
* 6\) Child with medical problems that could influence their diet or physical activity or make it difficult for that child to participate in a behavior change program (such as mental retardation, neurologic disorders, severe food allergies or severe cardiac or pulmonary disease that restricts their activities).
* 7\) Parents who participated in interviews during the developmental phase of Helping HAND
* 8\) Family currently participating in other weight treatment of prevention programs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
8 Years
Study:
NCT01195012
Study Brief:
Protocol Section:
NCT01195012