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

13 maja 2021 zaktualizowane przez: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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)

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

129

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Maryland
      • Bethesda, Maryland, Stany Zjednoczone, 20892
        • National Institutes of Health Clinical Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

7 lat do 11 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

  • INCLUSION CRITERIA:

Participants will qualify for the study if they meet the following criteria:

  1. Good general health.
  2. Age greater than or equal to 7 and less than 12 years.
  3. Fasting plasma glucose less than 100 mg/dL
  4. 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:

  1. Significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion.
  2. Evidence of impaired glucose tolerance or type 2 diabetes, including fasting plasma glucose greater than or equal to 100 mg/dL.
  3. Presence of other endocrinologic disorders leading to obesity (e.g.: Cushing Syndrome).
  4. 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.
  5. Participants who have, or are currently receiving, anti-psychotic drugs that would affect metabolism, cognitive outcomes, and body habitus.
  6. Participants receiving medical treatment other than diet for hypertension or dyslipidemia.
  7. Participants with precocious puberty and/or receiving androgen and estrogen therapy.
  8. 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.
  9. Presence of pre-existing neurocognitive disabilities, or an age-adjusted score below 85 on the Picture Vocabulary Test at the screening visit.
  10. 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.
  11. Presence of significant skin disease or allergy to adhesive material prohibiting placement of a continuous glucose monitor.
  12. Participants unable or unwilling to abstain from acetaminophen, ascorbic acid, or salicylic acid during study duration.
  13. Participant does not speak fluent English.
  14. Participant is or becomes pregnant.
  15. 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

  1. 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.
  2. 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.
  3. Requires sedation for MRI studies.
  4. Has a condition that makes entry into the scanner difficult (e.g. weight over 550 lbs, claustrophobia, etc.).
  5. 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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: 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.
Eksperymentalny: 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.
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Insulin iAUC Obtained During the Oral Glucose Tolerance Test at the Final Experimental Visit.
Ramy czasowe: test day 6
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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Glucose iAUC Obtained During the Oral Glucose Tolerance Test on Day # 6 of Intervention.
Ramy czasowe: test day 6
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.
Ramy czasowe: test day 6
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.
Ramy czasowe: test day 6
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.
Ramy czasowe: test days 1-6
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.
Ramy czasowe: test days 1-6
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.
Ramy czasowe: test day 6
Total energy intake (kcal) during buffet meal immediately after the end of intervention
test day 6
Percentage Fat Intake at the Final Test Meal.
Ramy czasowe: test day 6
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.
Ramy czasowe: test day 6
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.
Ramy czasowe: test day 6
Percentage Energy intake from Protein during buffet meal immediately after the end of intervention
test day 6

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

26 lipca 2017

Zakończenie podstawowe (Rzeczywisty)

26 czerwca 2020

Ukończenie studiów (Rzeczywisty)

23 lutego 2021

Daty rejestracji na studia

Pierwszy przesłany

19 lipca 2017

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 lipca 2017

Pierwszy wysłany (Rzeczywisty)

21 lipca 2017

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

11 czerwca 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 maja 2021

Ostatnia weryfikacja

4 stycznia 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 170130
  • 17-CH-0130 (Inny identyfikator: NIH Clinical Center - protocol number)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAk

Opis planu IPD

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

Ramy czasowe udostępniania IPD

Immediately following publication of the primary outcome for 5 years

Kryteria dostępu do udostępniania IPD

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

Typ informacji pomocniczych dotyczących udostępniania IPD

  • Protokół badania
  • Formularz świadomej zgody (ICF)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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