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 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT03781102
Eligibility Criteria:
Inclusion Criteria:
Child:
8-12-years-old (if the mother has more than one child in the age range, the oldest child will be invited to participate; other children will be invited to join if the mother wishes it, but will not be measured),
overweight/obese (≥85th percentile of BMI for age and sex, and ≥2 of the following T2D risk factors: family history of T2D in first or second degree relative; or, identify as a racial/ethnic minority; or, exhibit signs of insulin resistance or conditions associated with insulin resistance, or mother with T2D or GDM during gestation.
Able to read and speak English, and provide written assent.
Mother:
18-54 years-old,
BMI ≥ 25 kg/m2 and a risk score ≥5 on the seven-item American Diabetes Association's Diabetes Risk Assessment (84). In addition, women must have prediabetes, determined by an HbA1c value \>5.7% and \<6.5%, or, a self-reported or chart documented history of gestational diabetes mellitus with an HbA1c \<6.5% and/or casual capillary blood glucose \<199 mg/dL.
Must be willing to participate with their child in all intervention activities and sessions,
Able to read and speak English or Spanish, and provide informed consent.
Exclusion Criteria:
Mother:
No evidence of prediabetes
Currently pregnant or planning to become pregnant during the study
Have any condition or use any medication that could alter glucose metabolism or weight
Have suffered a heart attack, stroke or transient ischemic attack (TIA) in the past 6 months
Have uncontrolled hypertension (systolic \>180 mmHg or diastolic \>105 mmHg)
Received treatment for cancer (excluding surgery alone) within the last 2 years (excluding skin cancer)
Report chest pain, shortness of breath with minimal activity or at rest or unexplained dizziness or fainting with physical activity,
Have chronic lung disease, chronic obstructive pulmonary disease, or asthma requiring home oxygen therapy,
Current use of anti-diabetes medications for the treatment of diagnosed diabetes, are unable to communicate with research staff (including intervention staff),
Do not have a child within the designated age range (8-12-years-old),
Unable to speak or read English or Spanish.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
54 Years
Study:
NCT03781102
Study Brief:
Protocol Section:
NCT03781102