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

Primary Purpose

Healthy, Obesity, Overweight

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Walking Bouts

Sedentary

About this trial

This is an interventional prevention trial for Healthy focused on measuring Metabolism, Children, Walking Bouts, Glucose, Insulin

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.
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

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.
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.
Requires sedation for MRI studies.
Has a condition that makes entry into the scanner difficult (e.g. weight over 550 lbs, claustrophobia, etc.).
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.

Sites / Locations

National Institutes of Health Clinical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sedentary

Walking bouts

Arm Description

(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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Integrated area under the curve (iAUC) for glucose values during the oral glucose tolerance test, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion

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

Integrated area under the curve (iAUC) for C-Peptide values during the oral glucose tolerance test, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion

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

Integrated area under the curve (iAUC) for Free Fatty Acid values during the oral glucose tolerance test, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion

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

Mean 3-dimensional activity during the 3 hours of intervention from all days (step counts per minute)

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

Mean total daily 3-dimensional activity counts during the 21 hours without intervention on days 1-6 (activity counts/21 hours) from triaxial write accelerometers worn at home. Note: these are not "step counts" but total 3D activity counts because motion of the wrist at times other than walking are also recorded. There is no simple way to convert these counts to step counts.

Energy Intake at the Final Test Meal.

Total energy intake (kcal) during buffet meal immediately after the end of intervention

Percentage Fat Intake at the Final Test Meal.

Percentage Energy intake from Fat during buffet meal immediately after the end of intervention

Percentage Carbohydrate Intake at the Final Test Meal.

Percentage Energy intake from Carbohydrate during buffet meal immediately after the end of intervention

Percentage Protein Intake at the Final Test Meal.

Percentage Energy intake from Protein during buffet meal immediately after the end of intervention

Full Information

NCT ID

NCT03223649

First Posted

July 19, 2017

Last Updated

May 13, 2021

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT03223649

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 4, 2021

Overall Recruitment Status

Completed

Study Start Date

July 26, 2017 (Actual)

Primary Completion Date

June 26, 2020 (Actual)

Study Completion Date

February 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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)

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Obesity, Overweight

Keywords

Metabolism, Children, Walking Bouts, Glucose, Insulin

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

129 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sedentary

Arm Type

Experimental

Arm Description

(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.

Arm Title

Walking bouts

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Walking Bouts

Intervention Description

Intervention Type

Other

Intervention Name(s)

Sedentary

Intervention Description

(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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

test day 6

Secondary Outcome Measure Information:

Title

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

Description

Integrated area under the curve (iAUC) for glucose values during the oral glucose tolerance test, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion

Time Frame

test day 6

Title

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

Description

Integrated area under the curve (iAUC) for C-Peptide values during the oral glucose tolerance test, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion

Time Frame

test day 6

Title

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

Description

Integrated area under the curve (iAUC) for Free Fatty Acid values during the oral glucose tolerance test, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion

Time Frame

test day 6

Title

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

Description

Mean 3-dimensional activity during the 3 hours of intervention from all days (step counts per minute)

Time Frame

test days 1-6

Title

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

Description

Time Frame

test days 1-6

Title

Energy Intake at the Final Test Meal.

Description

Total energy intake (kcal) during buffet meal immediately after the end of intervention

Time Frame

test day 6

Title

Percentage Fat Intake at the Final Test Meal.

Description

Percentage Energy intake from Fat during buffet meal immediately after the end of intervention

Time Frame

test day 6

Title

Percentage Carbohydrate Intake at the Final Test Meal.

Description

Percentage Energy intake from Carbohydrate during buffet meal immediately after the end of intervention

Time Frame

test day 6

Title

Percentage Protein Intake at the Final Test Meal.

Description

Percentage Energy intake from Protein during buffet meal immediately after the end of intervention

Time Frame

test day 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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. 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 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. 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. Requires sedation for MRI studies. Has a condition that makes entry into the scanner difficult (e.g. weight over 550 lbs, claustrophobia, etc.). 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jack A Yanovski, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institutes of Health Clinical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual level deidentified data for all sociodemographic characteristics and outcomes will be made available after publication of the study primary outcome.

IPD Sharing Time Frame

Immediately following publication of the primary outcome for 5 years

IPD Sharing Access Criteria

A data sharing agreement may have to be negotiated with NICHD. Contact Dr. Jack Yanovski jy15i@nih.gov, 301-496-0858.

Citations:

PubMed Identifier

30082324

Citation

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.

Results Reference

background

PubMed Identifier

26312582

Citation

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.

Results Reference

background

PubMed Identifier

22374636

Citation

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.

Results Reference

background

Links:

URL

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2017-CH-0130.html

Description

NIH Clinical Center Detailed Web Page

Learn more about this trial

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

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