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

NCT01888939 | Completed Phase 1

• 2 other identifiers: 13016913-CH-0169
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Keywords

Executive Function; Child; Obesity; Exercise; Insulin Sensitivity

Outcome Measures

Primary Outcomes (1)

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

  3 hours

Secondary Outcomes (5)

• Lower postprandial glucose iAUC during 3 hours after the OGTT.

  3 hours

• Differences in executive functioning and attention scores.

  3 hours

• Differences in positive and negative affect scores.

  3 hours

• Differences in anxiety.

  3 hours

• Differences in post-test dietary intake.

  3 hours

Interventions

Walking on a Treadmill OTHER

Sedendary Activities Only OTHER

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants will qualify for the study if they meet the following criteria:
• Good general health.
• Age greater than or equal to 7 and \<11.99 years.
• Fasting plasma glucose \< 100 mg/dL
• 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.

You may not qualify if:

• Significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion.
• Evidence of impaired glucose tolerance or type 2 diabetes, including fasting plasma glucose greater than or equal to 100 mg/dL.
• Presence of other endocrinologic disorders leading to obesity (e.g.: Cushing Syndrome).
• 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.
• Participants who have, or are currently receiving, anti-psychotic drugs that would affect metabolism, cognitive outcomes, and body habitus.
• Participants receiving medical treatment other than diet for hypertension or dyslipidemia.
• Participants with precocious puberty and/or receiving androgen and estrogen therapy.
• Participants currently taking medications for ADHD, or any disorder or use of medications known to affect body composition or weight.
• Presence of pre-existing neurocognitive disabilities, or an age-adjusted score below 85 on the Picture Vocabulary Test at the screening visit.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead
• National Cancer Institute (NCI): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Kuczmarski RJ, Ogden CL, Guo SS, Grummer-Strawn LM, Flegal KM, Mei Z, Wei R, Curtin LR, Roche AF, Johnson CL. 2000 CDC Growth Charts for the United States: methods and development. Vital Health Stat 11. 2002 May;(246):1-190.

  PMID: 12043359 BACKGROUND

• Jago R, Harrell JS, McMurray RG, Edelstein S, El Ghormli L, Bassin S. Prevalence of abnormal lipid and blood pressure values among an ethnically diverse population of eighth-grade adolescents and screening implications. Pediatrics. 2006 Jun;117(6):2065-73. doi: 10.1542/peds.2005-1716.

  PMID: 16740849 BACKGROUND

• Ventura E, Davis J, Byrd-Williams C, Alexander K, McClain A, Lane CJ, Spruijt-Metz D, Weigensberg M, Goran M. Reduction in risk factors for type 2 diabetes mellitus in response to a low-sugar, high-fiber dietary intervention in overweight Latino adolescents. Arch Pediatr Adolesc Med. 2009 Apr;163(4):320-7. doi: 10.1001/archpediatrics.2009.11.

  PMID: 19349560 BACKGROUND

• Belcher BR, Berrigan D, Papachristopoulou A, Brady SM, Bernstein SB, Brychta RJ, Hattenbach JD, Tigner IL Jr, Courville AB, Drinkard BE, Smith KP, Rosing DR, Wolters PL, Chen KY, Yanovski JA. Effects of Interrupting Children's Sedentary Behaviors With Activity on Metabolic Function: A Randomized Trial. J Clin Endocrinol Metab. 2015 Oct;100(10):3735-43. doi: 10.1210/jc.2015-2803. Epub 2015 Aug 27.

  PMID: 26312582 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Jack A Yanovski, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: June 28, 2013
• Study Start: June 26, 2013
• Primary Completion: March 8, 2017
• Study Completion: January 29, 2018
• Last Updated: January 31, 2018

Record last verified: 2018-01-29

Locations

US (1)