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

13 mai 2021 mis à jour par: 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)

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

129

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Maryland
      • Bethesda, Maryland, États-Unis, 20892
        • National Institutes of Health Clinical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

7 ans à 11 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

  • 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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: 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.
Expérimental: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Insulin iAUC Obtained During the Oral Glucose Tolerance Test at the Final Experimental Visit.
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Glucose iAUC Obtained During the Oral Glucose Tolerance Test on Day # 6 of Intervention.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: test day 6
Percentage Energy intake from Protein during buffet meal immediately after the end of intervention
test day 6

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 juillet 2017

Achèvement primaire (Réel)

26 juin 2020

Achèvement de l'étude (Réel)

23 février 2021

Dates d'inscription aux études

Première soumission

19 juillet 2017

Première soumission répondant aux critères de contrôle qualité

19 juillet 2017

Première publication (Réel)

21 juillet 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 juin 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 mai 2021

Dernière vérification

4 janvier 2021

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 170130
  • 17-CH-0130 (Autre identifiant: NIH Clinical Center - protocol number)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Oui

Description du régime IPD

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

Délai de partage IPD

Immediately following publication of the primary outcome for 5 years

Critères d'accès au partage IPD

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

Type d'informations de prise en charge du partage d'IPD

  • Protocole d'étude
  • Formulaire de consentement éclairé (ICF)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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