National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
NCT Number: NCT03223649
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)
Looking for future studies?
Notify Me7 year–11 year
All sexes
Interventional
Phase 2
Bethesda, Maryland, 20892, United States
Background:
Sedentary behavior is defined as a set of low-intensity activities involving limited body movement (e.g.: TV viewing, prolonged sitting). Some studies have found higher levels of childhood sedentary behavior predict higher body mass index (BMI) and metabolic abnormalities. We and others have found that interrupting sitting with short, 2-3 minute bouts of moderate activity (walking) can improve glucose tolerance during a single session. Thus, interrupting sedentary behavior may be an intervention strategy to reduce health risks.
Objective:
We propose to conduct a randomized pilot study to assess whether interrupting sedentary behavior for 6 consecutive days provides sustained improvement in carbohydrate metabolism without negatively impacting executive function, attention, mood, anxiety, dietary
intake or usual physical activity.
Design & Population:
Using a randomized parallel group design, children, ages 7-11 years, will complete an assigned randomized condition of either 6 consecutive days of 3 hours of monitored sedentary activity (sitting) or 6 consecutive days of 3 hours of interrupted sitting (in which they will be prompted to walk for 3 minutes every 30 minutes).
Outcome measures:
Twenty-four-hour continuous glucose monitoring and postprandial insulin incremental area under the curve (iAUC) on post-condition oral glucose tolerance testing will be the primary measures. Secondary measures include: postprandial glucose iAUC, executive function, attention, mood, anxiety, dietary intake, and free-living physical activity.
Impact:
This project will investigate if consecutive daily interruption of sitting behaviors improves glucose tolerance, a potential negative health consequences of sedentary behavior in children. If repeatedly interrupting sitting with short bouts has sustained beneficial effects among children, interventions examining the frequency, duration, and intensity of such interruptions could be developed for use in the community setting. Thus, these results have the potential to provide insight into novel behavioral intervention targets in youth.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Participants will qualify for the study if they meet the following criteria:
Exclusion criteria
Participants will be excluded from the study for:
OPTIONAL MRS SUPPLEMENTAL ARM
Inclusion criteria
(a) Participants will qualify for the study if they qualify for the primary Break It Up! study.
Exclusion criteria
Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.
(Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.
Time frame: test day 6
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
Time frame: test day 6
Integrated area under the curve (iAUC) for glucose values during the oral glucose tolerance test, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion
Time frame: test day 6
Integrated area under the curve (iAUC) for C-Peptide values during the oral glucose tolerance test, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion
Time frame: test day 6
Integrated area under the curve (iAUC) for Free Fatty Acid values during the oral glucose tolerance test, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion
Time frame: test days 1-6
Mean 3-dimensional activity during the 3 hours of intervention from all days (step counts per minute)
Time frame: test days 1-6
Mean total daily 3-dimensional activity counts during the 21 hours without intervention on days 1-6 (activity counts/21 hours) from triaxial write accelerometers worn at home. Note: these are not "step counts" but total 3D activity counts because motion of the wrist at times other than walking are also recorded. There is no simple way to convert these counts to step counts.
Time frame: test day 6
Total energy intake (kcal) during buffet meal immediately after the end of intervention
Time frame: test day 6
Percentage Energy intake from Fat during buffet meal immediately after the end of intervention
Time frame: test day 6
Percentage Energy intake from Carbohydrate during buffet meal immediately after the end of intervention
Time frame: test day 6
Percentage Energy intake from Protein during buffet meal immediately after the end of intervention
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Nih
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06440980
Body Weight, Healthy
Anaheim, California, United States
View Trial DetailsNCT02836106
Body Weight, Healthy
Oslo, Norway
View Trial DetailsNCT03543644
Body Weight, Cardiovascular Diseases
Toronto, Ontario, Canada
View Trial DetailsNCT01115712
Body Weight, Healthy
View Trial Details