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

NCT03223649 | Completed Phase 2 Results

• 2 other identifiers: 17013017-CH-0130
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Healthy; Obesity; Overweight

Keywords

Metabolism; Children; Walking Bouts; Glucose; Insulin

Outcome Measures

Primary Outcomes (1)

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

  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

  test day 6

Secondary Outcomes (9)

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

  test day 6

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

  test day 6

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

  test day 6

• Daily Physical Activity (Step Counts/Min) During Intervention.

  test days 1-6

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

  test days 1-6

Study Arms (2)

Sedentary

EXPERIMENTAL

(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.

Other: Sedentary

Walking bouts

EXPERIMENTAL

Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.

Other: Walking Bouts

Interventions

Walking Bouts OTHER

Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.

Walking bouts

Sedentary OTHER

(Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.

Sedentary

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 less than 12 years.
• Fasting plasma glucose less than 100 mg/dL
• Body mass index (BMI) greater than or equal to the 5th percentile, as determined by the CDC age- and sex- specific growth charts.

You may not qualify if:

• Participants will be excluded from the study for:
• 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 including but not limited to glucocorticoids or other steroid compounds.
• Presence of pre-existing neurocognitive disabilities, or an age-adjusted score below 85 on the Picture Vocabulary Test at the screening visit.
• 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.
• Presence of significant skin disease or allergy to adhesive material prohibiting placement of a continuous glucose monitor.
• Participants unable or unwilling to abstain from acetaminophen, ascorbic acid, or salicylic acid during study duration.
• Participant does not speak fluent English.
• Participant is or becomes pregnant.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Broadney MM, Belcher BR, Berrigan DA, Brychta RJ, Tigner IL Jr, Shareef F, Papachristopoulou A, Hattenbach JD, Davis EK, Brady SM, Bernstein SB, Courville AB, Drinkard BE, Smith KP, Rosing DR, Wolters PL, Chen KY, Yanovski JA. 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. Diabetes Care. 2018 Oct;41(10):2220-2228. doi: 10.2337/dc18-0774. Epub 2018 Aug 6.

  PMID: 30082324 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 BACKGROUND

• Dunstan DW, Kingwell BA, Larsen R, Healy GN, Cerin E, Hamilton MT, Shaw JE, Bertovic DA, Zimmet PZ, Salmon J, Owen N. Breaking up prolonged sitting reduces postprandial glucose and insulin responses. Diabetes Care. 2012 May;35(5):976-83. doi: 10.2337/dc11-1931. Epub 2012 Feb 28.

  PMID: 22374636 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Obesity; Overweight; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jack A. Yanovski, MD, PhD
• Organization: National Institutes of Health

jy15i@nih.gov

3014960858

Study Officials

• Jack A Yanovski, M.D.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 21, 2017
• Study Start: July 26, 2017
• Primary Completion: June 26, 2020
• Study Completion: February 23, 2021
• Last Updated: June 11, 2021
• Results First Posted: June 11, 2021

Record last verified: 2021-01-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication of the primary outcome for 5 years
• Access Criteria: A data sharing agreement may have to be negotiated with NICHD. Contact Dr. Jack Yanovski jy15i@nih.gov, 301-496-0858.

Locations

US (1)