NCT03223649

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

Completed Phase 2 Results posted Last updated 11 June 2021

What this trial tests

Phase 2 trial testing Walking Bouts in Healthy in 129 participants. Completed in 23 February 2021.

Timeline

26 July 2017

Primary endpoint
26 June 2020

23 February 2021

Quick facts

Lead sponsor	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	129
Start date	26 July 2017
Primary completion	26 June 2020
Estimated completion	23 February 2021
Sites	1 location across United States

Drugs / interventions tested

• Walking Bouts
• Sedentary

Conditions studied

• Healthy — all drugs for Healthy →
• Obesity — all drugs for Obesity →
• Overweight — all drugs for Overweight →

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Who can join

Adults 7 to 11, any sex, with Healthy or Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Insulin iAUC Obtained During the Oral Glucose Tolerance Test at the Final Experimental Visit. Primary · 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

Group	Value	95% CI
Sedentary	13,698.60	± 9414.9
Walking Bouts	10,619.70	± 6,781.30

Glucose iAUC Obtained During the Oral Glucose Tolerance Test on Day # 6 of Intervention. Secondary · 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

Group	Value	95% CI
Sedentary	22,247.90	± 2,927.70
Walking Bouts	21,688.80	± 2,473.70

C-Peptide iAUC Obtained During the Oral Glucose Tolerance Test on Day # 6 of Intervention. Secondary · 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

Group	Value	95% CI
Sedentary	1,292.10	± 449.8
Walking Bouts	1,160.10	± 448.8

Free Fatty Acid iAUC Obtained During the Oral Glucose Tolerance Test on Day # 6 of Intervention. Secondary · 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

Group	Value	95% CI
Sedentary	39.7	± 9.8
Walking Bouts	38.5	± 13.1

Daily Physical Activity (Step Counts/Min) During Intervention. Secondary · test days 1-6

Mean 3-dimensional activity during the 3 hours of intervention from all days (step counts per minute)

Group	Value	95% CI
Sedentary	5.4	± 1.9
Walking Bouts	11.2	± 3.0

Daily Physical Activity (3-dimensional Activity Counts/Day) Outside of the Intervention. Secondary · 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.

Group	Value	95% CI
Sedentary	2.1	± 0.6
Walking Bouts	2.2	± 0.5

Energy Intake at the Final Test Meal. Secondary · test day 6

Total energy intake (kcal) during buffet meal immediately after the end of intervention

Group	Value	95% CI
Sedentary	1,312.4	± 478.4
Walking Bouts	1,207.4	± 443.8

Percentage Fat Intake at the Final Test Meal. Secondary · test day 6

Percentage Energy intake from Fat during buffet meal immediately after the end of intervention

Group	Value	95% CI
Sedentary	35.8	± 7.0
Walking Bouts	36.2	± 6.0

Percentage Carbohydrate Intake at the Final Test Meal. Secondary · test day 6

Percentage Energy intake from Carbohydrate during buffet meal immediately after the end of intervention

Group	Value	95% CI
Sedentary	52.0	± 9.0
Walking Bouts	51.8	± 8.4

Percentage Protein Intake at the Final Test Meal. Secondary · test day 6

Percentage Energy intake from Protein during buffet meal immediately after the end of intervention

Group	Value	95% CI
Sedentary	12.2	± 3.6
Walking Bouts	12.0	± 3.2

Sponsor's own description

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)

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Free Fatty Acids as an Indicator of the Nonfasted State in Children.
   Collins SM, Broadney MM, Ghane N, Davis EK, et al · · 2019 · cited 5× · PMID 31053621 · DOI 10.1542/peds.2018-3896
2. Effects of interrupting daily sedentary behavior on children's glucose metabolism: A 6-day randomized controlled trial.
   Broadney MM, Belcher BR, Ghane N, Sheni R, et al · · 2022 · cited 2× · PMID 36205036 · DOI 10.1111/pedi.13430