Effects of Multi-day Interruptions in Sitting on Type 2 Diabetes-relevant Outcomes in Children (NCT04469790) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of Multi-day Interruptions in Sitting on Type 2 Diabetes-relevant Outcomes in Children
United States188 participantsStarted 2022-03-01
Plain-language summary
The overall objective of this in-lab randomized controlled trial is to test the efficacy of multi-day interruptions in sedentary behavior vs. single bouts of sustained exercise on metabolic, cognitive, affective, and cardiac autonomic nervous system responses in children with overweight and obesity who are at risk for type 2 diabetes. The use of continuous glucose monitoring will provide insight into the daily and cumulative metabolic effects of each condition that have thus far not been studied. In-lab studies demonstrating sustained efficacy of this approach in ameliorating negative effects of sedentary behaviors in children are necessary for the optimization of field-based interventions. Given the lack of success of interventions to prevent obesity-related diseases and increasing rates of type 2 diabetes in children and its related healthcare costs, this study addresses a critical public health need by testing of novel intervention strategies to reduce obesity-related diseases in children with overweight and obesity.
Who can participate
Age range
8 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 8-11 years-old
. Good general health
. BMI≥85th percentile
Exclusion criteria
. Significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion
. Diagnosis of T2DM and/or presence of other endocrinologic disorders leading to obesity (e.g., Cushing Syndrome)
. Current or past anti-psychotic drug use that would affect metabolism
. Non-diet treatment for hypertension or dyslipidemia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is specifically about breaking up long sitting time in children and measuring blood sugar and insulin responses — given my child's current metabolic health, is this kind of intervention something worth exploring for them?
2The trial is measuring glucose, insulin, and c-peptide levels over multiple days, which involves blood draws and wearing a continuous glucose monitor — how would my child likely handle that level of monitoring, and are there any risks we should weigh?
3Since this study is listed as 'active, not recruiting,' does that mean enrollment is closed, and if so, are there similar studies or programs looking at sedentary behavior and metabolic health in children that my child might still be able to join?
4The trial involves interrupting sitting with activity breaks, which is a behavioral intervention rather than a medication — how does this compare to other approaches you might already recommend for managing my child's metabolic or blood sugar concerns?
5The study also tracks anxiety and mood alongside the metabolic outcomes — is there something about the connection between sitting, mental well-being, and blood sugar regulation in children that would be relevant to discuss for my child's overall care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
In-Lab glucose area under the curve (AUC)
Timeframe: 3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) AUC change from Day 1 to Day 7
2
In-Lab insulin area under the curve (AUC)
Timeframe: 3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) AUC change from Day 1 to Day 7
3
In-Lab c-peptide area under the curve (AUC)
Timeframe: 3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) AUC change from Day 1 to Day 7