Break It Up: A Study Evaluating Breaking Up Daily Sedentary Behavior in Youth
Condition: Healthy; Obesity; Overweight
MeSH terms: Overweight
Intervention: Walking Bouts; Sedentary
Intervention description: 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.; (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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 7 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Metabolism; Children; Walking Bouts; Glucose; Insulin

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)
    

Eligibility criteria:

        -  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.