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Effects of Interrupting Sedentary Behavior on Metabolic and Cognitive Outcomes in Children

Phase 1/Phase 2
7 Years
11 Years
Open (Enrolling)
Healthy Volunteer

Thank you

Trial Information

Effects of Interrupting Sedentary Behavior on Metabolic and Cognitive Outcomes in Children

Prevention of pediatric obesity and its complications are U.S. public health priorities.
Promoting physical activity has been proposed as an intervention strategy. Apart from
reducing excessive weight, physical activity improves cardiovascular fitness, insulin
sensitivity, and academic performance. However, emerging evidence in adults suggests that
increased physical activity may not entirely counteract the negative health effects of a
sedentary lifestyle.

Sedentary behavior is defined as a set of low-intensity activities involving limited body
movement (e.g.: TV viewing, prolonged sitting). TV viewing is associated with lower
cognitive functioning and depressive symptoms. Some studies found higher levels of childhood
sedentary behavior predicted higher body mass index (BMI) and cholesterol in adulthood,
suggesting that negative health consequences may begin early. Dunstan et al. conducted the
first lab-based study in adults investigating interrupting prolonged sedentary behavior with
physical activity breaks. The authors found that for overweight adults, adding 2-minute
moderate-intensity walking breaks every 20 minutes reduced postprandial insulin and glucose
responses by 23.0% and 29.6%, respectively. Thus, interrupting sedentary behavior may be an
intervention strategy to reduce health risks.

In children, cross-sectional observational studies indicate that sedentary behavior patterns
characterized by short bouts of activity are not associated with increased cardiometabolic
risk. However to date, no in-lab studies have manipulated sedentary behavior in children.
Therefore, we propose to conduct a randomized crossover pilot feasibility study to assess
whether interrupting sedentary behavior influences metabolic and executive function,
attention, mood, anxiety, and dietary intake. Children, ages 7-11 years, will complete two
conditions in random order: 3 hours of prolonged sitting and 3 hours of sitting interrupted
with 3 minutes of moderate-intensity walking every 30 minutes. The specific aim of this
project is to investigate whether interrupting sedentary behavior improves metabolic
parameters and changes executive function, attention, mood, anxiety, and dietary intake. The
primary hypothesis is that postprandial insulin incremental area under the curve (iAUC) will
be lower in the interrupted sitting vs. the prolonged sitting condition. The exploratory
secondary hypotheses are that glucose iAUC, executive function, attention, mood, anxiety,
and dietary intake will differ between the two conditions.

This project will investigate if interrupting sedentary time affects potential negative
health consequences of sedentary behavior in children. If interrupting sedentary time in
short bouts has beneficial effects among children, interventions examining the frequency,
duration, and intensity of such interruptions could be developed. Thus, these results have
the potential to provide insight into novel behavioral intervention targets in youth.

Inclusion Criteria


Participants will qualify for the study if they meet the following criteria:

1. Good general health.

2. Age greater than or equal to 7 and < 11.99 years.

3. Fasting plasma glucose < 100 mg/dL

4. a) Phase 1: Body mass index (BMI) between the 5th and 85th percentiles, as determined
by the CDC age- and sex- specific growth charts.

b) Phase 2: BMI above the 85th percentile, as determined by the CDC age- and sex-
specific growth charts.


1. Significant cardiac or pulmonary disease likely to or resulting in hypoxia or
decreased perfusion.

2. Evidence of impaired glucose tolerance or type 2 diabetes, including fasting plasma
glucose greater than or equal to 100 mg/dL.

3. Presence of other endocrinologic disorders leading to obesity (e.g.: Cushing

4. Participants who have, or whose parent/guardians have, current substance abuse or a
psychiatric disorder or other condition that, in the opinion of the investigators,
would impede competence, compliance, or prevent the completion of the study.

5. Participants who have, or are currently receiving, anti-psychotic drugs that would
affect metabolism, cognitive outcomes, and body habitus.

6. Participants receiving medical treatment other than diet for hypertension or

7. Participants with precocious puberty and/or receiving androgen and estrogen therapy.

8. Participants currently taking medications for ADHD, or any disorder or use of
medications known to affect body composition or weight.

9. Presence of pre-existing neurocognitive disabilities, or an age-adjusted score below
85 on the Picture Vocabulary Test at the screening visit.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Lower insulin incremental area under the curve (iAUC) during 3 hours after the OGTT.

Outcome Time Frame:

3 hours

Safety Issue:


Principal Investigator

Jack A Yanovski, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


United States: Federal Government

Study ID:




Start Date:

June 2013

Completion Date:

December 2017

Related Keywords:

  • Healthy Volunteer
  • Executive Function
  • Child
  • Obesity
  • Exercise
  • Insulin Sensitivity



National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892