Status:
COMPLETED
Effects of Interrupting Sedentary Behavior on Metabolic and Cognitive Outcomes in Children
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsors:
National Cancer Institute (NCI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy Volunteer
Eligibility:
All Genders
7-11 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: \- Some studies in adults have found that insulin and glucose blood levels are lower when a long period of sitting is broken up with walking, compared to sitting without breaks. This mean...
Detailed Description
Prevention of pediatric obesity and its complications are U.S. public health priorities. Promoting physical activity has been proposed as an intervention strategy. Apart from reducing excessive weight...
Eligibility Criteria
Inclusion
- 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 \<11.99 years.
- Fasting plasma glucose \< 100 mg/dL
- a) Phase 1: Body mass index (BMI) between the 5th and 85th percentiles, as determined by the CDC age- and sex- specific growth charts.
- b) Phase 2: BMI above the 85th percentile, as determined by the CDC age- and sex- specific growth charts.
- EXCLUSION CRITERIA:
- 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.
- Presence of pre-existing neurocognitive disabilities, or an age-adjusted score below 85 on the Picture Vocabulary Test at the screening visit.
Exclusion
Key Trial Info
Start Date :
June 26 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2018
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT01888939
Start Date
June 26 2013
End Date
January 29 2018
Last Update
January 31 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892