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| ID | Type | Description | Link |
|---|---|---|---|
| 17-CH-0130 | Other Identifier | NIH Clinical Center - protocol number |
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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:
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:
Participants will fast before the last visit in the morning. They will have:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | test day 6 |
| C-Peptide iAUC Obtained During the Oral Glucose Tolerance Test on Day # 6 of Intervention. |
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Participants will qualify for the study if they meet the following criteria:
EXCLUSION CRITERIA:
Participants will be excluded from the study for:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Jack A Yanovski, M.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30082324 | Background | 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. | |
| 26312582 |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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Individual level deidentified data for all sociodemographic characteristics and outcomes will be made available after publication of the study primary outcome.
Immediately following publication of the primary outcome for 5 years
A data sharing agreement may have to be negotiated with NICHD. Contact Dr. Jack Yanovski jy15i@nih.gov, 301-496-0858.
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Of the 129 participants who were evaluated with baseline screening, 20 were not studied further:
12: Failed to meet inclusion criteria
6: No longer interested
1: Could not determine VO2 max or lactate threshold from exercise testing (insufficient effort)
1: Withdrawn due to COVID pandemic restrictions
Participants were recruited via multiple methods:
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| ID | Title | Description |
|---|---|---|
| FG000 | Sedentary | (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: (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. |
| FG001 | Walking Bouts | 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 thresholdas determined during a V02max test. Walking Bouts: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who completed the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Sedentary | (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: (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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | mIU/dL∙min | test day 6 |
|
Days 1-6
Standard clinicaltrials.gov definitions were used.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sedentary | (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: (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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jack A. Yanovski, MD, PhD | National Institutes of Health | 3014960858 | jy15i@nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2020 | Apr 21, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 28, 2020 | Apr 21, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| 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. |
|
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 |
| test day 6 |
| 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 | test day 6 |
| 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) | test days 1-6 |
| 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. | test days 1-6 |
| Energy Intake at the Final Test Meal. | Total energy intake (kcal) during buffet meal immediately after the end of intervention | test day 6 |
| Percentage Fat Intake at the Final Test Meal. | Percentage Energy intake from Fat during buffet meal immediately after the end of intervention | test day 6 |
| Percentage Carbohydrate Intake at the Final Test Meal. | Percentage Energy intake from Carbohydrate during buffet meal immediately after the end of intervention | test day 6 |
| Percentage Protein Intake at the Final Test Meal. | Percentage Energy intake from Protein during buffet meal immediately after the end of intervention | test day 6 |
| 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. |
| 22374636 | 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. |
| BG001 |
| Walking Bouts |
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 thresholdas determined during a V02max test. Walking Bouts: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Fat Mass (kg) | Mean | Standard Deviation | kg |
|
| Lean Mass (kg) | Mean | Standard Deviation | kg |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
| BMI (kg/m2) | Weight in kg divided by the height, in meters, squared | Mean | Standard Deviation | kg/m2 |
|
| BMI z-score | The BMI Z-score indicates the number of standard deviations away from the mean BMI for age and sex. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population US National Standards for boys and girls from the Centers for Disease Control, which employs the LMS method for determining the Z-score | Mean | Standard Deviation | z-score |
|
| Fasting glucose (mg/dL) | Mean | Standard Deviation | mg/dL |
|
| Fasting insulin (mIU/ml) | Mean | Standard Deviation | mIU/mL |
|
| Peak VO2 (ml/kg/min) | Peak oxygen consumption per kg body weight per minute during an exercise test. | Mean | Standard Deviation | ml/kg/min |
|
| IPAQ score | Average physical activity level within the previous 7 days reported on a questionnaire
| Mean | Standard Deviation | units on a scale (1-4) |
|
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 thresholdas determined during a V02max test. Walking Bouts: 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. |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | mg/dL∙min | test day 6 |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | ng/dL∙min | test day 6 |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | mmol/L∙min | test day 6 |
|
|
|
|
| Secondary | 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) | Data were unavailable from two participants randomized to the Sedentary condition and from one participant randomized to the Walking Bouts condition. | Posted | Mean | Standard Deviation | step count per minute | test days 1-6 |
|
|
|
|
| Secondary | 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. | Data were unavailable from two participants randomized to the Sedentary condition and from one participant randomized to the Walking Bouts condition. | Posted | Mean | Standard Deviation | activity counts per 21 hours x 10^6 | test days 1-6 |
|
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|
|
| Secondary | Energy Intake at the Final Test Meal. | Total energy intake (kcal) during buffet meal immediately after the end of intervention | Data were unavailable from two participants randomized to the Sedentary condition and from two participants randomized to the Walking Bouts condition. | Posted | Mean | Standard Deviation | kcal | test day 6 |
|
|
|
|
| Secondary | Percentage Fat Intake at the Final Test Meal. | Percentage Energy intake from Fat during buffet meal immediately after the end of intervention | Data were unavailable from two participants randomized to the Sedentary condition and from two participants randomized to the Walking Bouts condition. | Posted | Mean | Standard Deviation | percentage of total energy intake (%) | test day 6 |
|
|
|
|
| Secondary | Percentage Carbohydrate Intake at the Final Test Meal. | Percentage Energy intake from Carbohydrate during buffet meal immediately after the end of intervention | Data were unavailable from two participants randomized to the Sedentary condition and from two participants randomized to the Walking Bouts condition. | Posted | Mean | Standard Deviation | percentage of total energy intake (%) | test day 6 |
|
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|
| Secondary | Percentage Protein Intake at the Final Test Meal. | Percentage Energy intake from Protein during buffet meal immediately after the end of intervention | Data were unavailable from two participants randomized to the Sedentary condition and from two participants randomized to the Walking Bouts condition. | Posted | Mean | Standard Error | percentage of total energy intake (%) | test day 6 |
|
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Walking Bouts | 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 thresholdas determined during a V02max test. Walking Bouts: 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. | 0 | 51 | 0 | 51 | 0 | 51 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |