NCT01888939

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

Completed Phase 1, PHASE2 Last updated 31 January 2018

What this trial tests

Phase 1, PHASE2 trial testing Walking on a Treadmill in Healthy Volunteer in 89 participants. Completed in 29 January 2018.

Timeline

26 June 2013

Primary endpoint
8 March 2017

29 January 2018

Quick facts

Lead sponsor	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	89
Start date	26 June 2013
Primary completion	8 March 2017
Estimated completion	29 January 2018
Sites	1 location across United States

Drugs / interventions tested

• Walking on a Treadmill
• Sedendary Activities Only

Conditions studied

• Healthy Volunteer — all drugs for Healthy Volunteer →

Sponsor

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

Who can join

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

Sponsor's own description

Background:

\- Some studies in adults have found that insulin and glucose blood levels are lower when a long period of sitting is broken up with walking, compared to sitting without breaks. This means that the body can better process sugars when there are walking breaks during the day. Researchers want to know if this is also true for children. Some studies have found that children s attention and memory might be better after exercise. Researchers want to know if short walking breaks have the same effects.

Objectives:

\- To understand if breaking up sitting with walking helps children s bodies better use sugars and improves children s concentration.

Eligibility:

\- Healthy children ages 7 to 11.

Design:

* Participants will be screened with a physical exam, medical history, exercise test, picture vocabulary test, and medical tests including blood tests and X-rays.
* Participants will return for two 7-hour visits. In the month before the visits, they will wear a physical activity monitor for one week so researchers know how active they are. Once they will take the sitting only test and once the sitting breaks test.
* During the sitting only test, participants will sit for 3 hours.
* During the sitting breaks test, they will sit for 3 hours with 3-minute walking breaks every 30 minutes.
* Both days, they will drink sugar water. Then the participants will have blood drawn from a needle that is kept in place, and they will wear a heart monitor. They will take attention and working memory tests on a computer and answer questions about how they feel. They will eat a meal at the end of the test day.

Publications & conference data

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

1. Effects of Interrupting Children's Sedentary Behaviors With Activity on Metabolic Function: A Randomized Trial.
   Belcher BR, Berrigan D, Papachristopoulou A, Brady SM, et al · · 2015 · cited 52× · PMID 26312582 · DOI 10.1210/jc.2015-2803
2. Effects of Interrupting Sedentary Behavior With Short Bouts of Moderate Physical Activity on Glucose Tolerance in Children With Overweight and Obesity: A Randomized Crossover Trial.
   Broadney MM, Belcher BR, Berrigan DA, Brychta RJ, et al · · 2018 · cited 32× · PMID 30082324 · DOI 10.2337/dc18-0774
3. The Effects of Interrupting Sitting Time on Affect and State Anxiety in Children of Healthy Weight and Overweight: A Randomized Crossover Trial.
   Zink J, Berrigan DA, Broadney MM, Shareef F, et al · · 2020 · cited 5× · PMID 32163927 · DOI 10.1123/pes.2019-0169
4. 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