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

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.

- 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 less than 12 years.

3. Fasting plasma glucose less than 100 mg/dL

4. Body mass index (BMI) greater than or equal to the 5th percentile, as determined by
the CDC age- and sex- specific growth charts.

EXCLUSION CRITERIA:

Participants will be excluded from the study for:

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
Syndrome).

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
dyslipidemia.

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 including but not limited to
glucocorticoids or other steroid compounds.

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

10. Presence of food allergies, such as peanut/tree nut, dairy, soy or any other food
allergy or personal dietary restrictions that would preclude participant from
consuming the daily diet or the buffet.

11. Presence of significant skin disease or allergy to adhesive material prohibiting
placement of a continuous glucose monitor.

12. Participants unable or unwilling to abstain from acetaminophen, ascorbic acid, or
salicylic acid during study duration.

13. Participant does not speak fluent English.

14. Participant is or becomes pregnant.

15. Participant has an ambulatory impairment

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

1. Cannot have MRI scanning. Some of the reasons a child might not be able to have MRI
include:

- Implanted cardiac pacemaker or defibrillator

- Cochlear Implants

- Ocular foreign body (e.g. metal shavings)

- Embedded shrapnel fragments

- Central nervous system aneurysm clips

- Implanted neural stimulator

- Medical infusion pumps

- Any implanted device that is incompatible with MRI.

2. Is not likely to tolerate an MRI scan. Examples of medical conditions that would make
it difficult to undergo MRI include severe anxiety (nervousness) or hyperactivity
which make it hard for your child to lay flat for the study.

3. Requires sedation for MRI studies.

4. Has a condition that makes entry into the scanner difficult (e.g. weight over 550 lbs,
claustrophobia, etc.).

5. Has severe back-pain or motion disorders that make it hard for a child to lie on
his/her back within the MRI scanner and hold still for the scan.