NCT03223649

Break It Up: A Study Evaluating Breaking Up Daily Sedentary Behavior in Youth

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 7 Years – 11 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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.

Conditions

• Healthy
• Obesity
• Overweight

Interventions

Type	Name	Description
OTHER	Walking Bouts	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.
OTHER	Sedentary	(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.

Timeline

• Start date: 2017-07-26
• Primary completion: 2020-06-26
• Completion: 2021-02-23
• First posted: 2017-07-21
• Last updated: 2021-06-11
• Results posted: 2021-06-11

Locations

1 site across 1 country: United States