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Sedentary Interruptions + Exercise for Reducing Type 2 Diabetes Risk in Children

N/A

Recruiting

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pre- or peri-puberty

Age 7-11 years-old

Must not have

Significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion

Evidence of impaired glucose tolerance or T2DM, presence of other endocrinologic disorders leading to obesity (e.g., Cushing Syndrome)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) auc change from day 1 to day 7

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effects of multi-day interruptions in sedentary behavior vs. single bouts of sustained exercise on metabolic, cognitive, and affective responses in children with overweight and obesity who are at risk for type 2 diabetes.

Who is the study for?

This trial is for children aged 7-11 who are overweight or obese, with a BMI in the top 15% for their age. They must have normal fasting blood sugar levels and be generally healthy without any significant heart or lung diseases, endocrine disorders like Cushing Syndrome, or treatments affecting body weight.

What is being tested?

The study compares two ways to reduce sedentary behavior's negative effects on kids at risk for type 2 diabetes: breaking up sitting time over several days versus single sessions of exercise. It measures how these methods affect metabolism, mood, cognitive function, and heart rate variability using continuous glucose monitoring.

What are the potential side effects?

Since this trial involves basic physical activity interventions such as walking breaks or exercise sessions rather than medication, side effects may include typical exercise-related discomforts like muscle soreness but no severe drug-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not gone through puberty yet.

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I am between 7 and 11 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious heart or lung conditions that affect my breathing or blood flow.

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I have diabetes or a condition like Cushing Syndrome that causes obesity.

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I have used anti-psychotic drugs that may affect my metabolism.

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I am being treated for early puberty with hormone therapy.

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I am on medication for high blood pressure or cholesterol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) auc change from day 1 to day 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) auc change from day 1 to day 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) auc change from day 1 to day 7 for reporting.