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NCT03223649 · ClinicalTrials.gov registry record · Phase 2
Break It Up: A Study Evaluating Breaking Up Daily Sedentary Behavior in Youth
A Phase 2 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
NCT03223649: Completed Phase 2 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT03223649 is a Phase 2 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 129 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03223649, a Phase 2 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
Study Summary
Background: Some studies have found that people can better process sugars when they take walking breaks. Studies have also found that children's attention and memory may improve after exercise. It is not known if short walking breaks have the same effects. Researchers want to study if breaking up sitting with walking for 6 days helps children s bodies use sugars and improves concentration. Objectives: To learn if breaking up sedentary (low-activity) time with short walking breaks over 6 days affects how children s bodies use sugar. To learn if breaking up sedentary time changes children s attention, memory, feelings, activity, or eating. Eligibility: Children ages 7-11 in general good health Design: Participants will be screened with: * Medical history * Physical exam * Fasting blood tests. On 2 out of 7 total study visits, participants cannot eat or drink after 10 p.m. the night before. * Full-body X-ray * EKG (Electronic signals that record heart function through stickers) * Treadmill exercise. Heart, blood pressure, and oxygen will be monitored. * Questions about the child s health, socialization, and activity, and parent s education and economic status * Picture vocabulary test * Dietician meeting (Questions about eating habits) Participants will have visits on 6 consecutive days. Over that time, they will wear 2 devices to monitor blood sugar and activity (even while at home). Participants will have 5 after-school visits. These include: * Health check * Snack plus food for the next 24 hours * Activity monitored * 3-hour sitting tests. Participants will do non-active things. Some will have 3-minute walks every 30 minutes. * Cognitive tests and questions about mood and anxiety are given on days #1 \& 5. Participants will fast before the last visit in the morning. They will have: * 9 blood draws by IV catheter. Participants will drink sugar water. * Sitting test * Activity monitored * Meal (food buffet)
Primary Outcome
Insulin integrated area under the curve (iAUC) as a marker of glucose metabolism on OGTT during test day #6, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion
Interventions
- OTHER Walking Bouts
- OTHER Sedentary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2017-07-26 |
| Est. Completion | 2021-02-23 |
| Phase | Phase 2 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT03223649 record still lists
NCT03223649 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Walking Bouts is the first listed.
NCT03223649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03223649 about?
NCT03223649 is a clinical study titled "Break It Up: A Study Evaluating Breaking Up Daily Sedentary Behavior in Youth". Background: Some studies have found that people can better process sugars when they take walking breaks. Studies have also found that children's attention and memory may improve after exercise. It is not known if short walking breaks have the same effects. Researchers want to study if breaking up s...
What is the current status of trial NCT03223649?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2017-07-26. Estimated completion is 2021-02-23.
What interventions are being tested in trial NCT03223649?
The interventions under investigation include: Walking Bouts (OTHER), Sedentary (OTHER).
Who is sponsoring clinical trial NCT03223649?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03223649's enrollment target sits among peer trials
129 553rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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