Viewing Study NCT00315172



Ignite Creation Date: 2024-05-05 @ 4:46 PM
Last Modification Date: 2024-10-26 @ 9:24 AM
Study NCT ID: NCT00315172
Status: COMPLETED
Last Update Posted: 2017-07-02
First Post: 2006-04-15

Brief Title: Non-Exercise Activity Thermogenesis NEAT in Children
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Non-Exercise Activity Thermogenesis NEAT in Children
Status: COMPLETED
Status Verified Date: 2008-11-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Non-exercise activity thermogenesis NEAT is the energy expended engaging in daily activities such as maintenance of posture fidgeting and other activities not specifically designated as exercise A growing body of evidence indicates that NEAT plays an important role in overall energy balance for example differences in NEAT account for the ease with which adults gain or lose weight during over- or under feeding An intriguing and possibly modifiable component of NEAT is fidgeting-like activity In lean and overweight adults modulation of NEAT by augmenting fidgeting can increase short-term energy expenditure It is unknown whether NEAT can be altered in children or whether augmenting NEAT in children can change daily energy expenditure or body composition long-term Children exhibit higher levels of daily activity than adults suggesting potentially profound differences in energy balance We propose to study the role of NEAT in children to determine if a the fidgeting component of NEAT can be measured accurately and reproducibly in children b NEAT can be increased by devices that remind children to engage in fidgeting-like activities and c manipulation of fidgeting-NEAT can significantly change energy expenditure and body composition Thirty lean and thirty overweight children will be enrolled and treated in a pilot feasibility study By adapting technologies developed to measure activity in adults childrens behavior and thermogenesis will be recorded and analyzed to study question a To address study questions b and c we will ask children to wear a timer that vibrate on a fixed interval schedule and be randomly assigned to two conditions the intervention or active condition during which children will be cued by the timer to engage in a fidgeting behavior rapidly moving their heel up and down and the control condition during which children will be asked to perform a less thermogenic activity noting the cue Children will then cross over so that each child will complete both conditions Primary outcome measures for question a will be changes in energy expenditure when subjects are asked to fidget in a laboratory environment The correlation of these energy expenditure measurements with new activity monitoring technologies will also be obtained so that such equipment can be used for measurements under free-living conditions For study questions b and c compliance with prescribed fidgeting regimens in a free living environment and the changes in energy expenditure and body composition will be determined over a 2 week interval This pilot study will enable the determination of the sample size needed to assess the efficacy of a longer term NEAT intervention in children
Detailed Description: Non-exercise activity thermogenesis NEAT is the energy expended engaging in daily activities such as maintenance of posture fidgeting and other activities not specifically designated as exercise A growing body of evidence indicates that NEAT plays an important role in overall energy balance for example differences in NEAT account for the ease with which adults gain or lose weight during over- or under feeding An intriguing and possibly modifiable component of NEAT is fidgeting-like activity In lean and overweight adults modulation of NEAT by augmenting fidgeting can increase short-term energy expenditure It is unknown whether NEAT can be altered in children or whether augmenting NEAT in children can change daily energy expenditure or body composition long-term Children exhibit higher levels of daily activity than adults suggesting potentially profound differences in energy balance We propose to study the role of NEAT in children to determine if a the fidgeting component of NEAT can be measured accurately and reproducibly in children b NEAT can be increased by devices that remind children to engage in fidgeting-like activities and c manipulation of fidgeting-NEAT can significantly change energy expenditure and body composition Thirty lean and thirty overweight children will be enrolled and treated in a pilot feasibility study By adapting technologies developed to measure activity in adults childrens behavior and thermogenesis will be recorded and analyzed to study question a To address study questions b and c we will ask children to wear a timer that vibrate on a fixed interval schedule and be randomly assigned to two conditions the intervention or active condition during which children will be cued by the timer to engage in a fidgeting behavior rapidly moving their heel up and down and the control condition during which children will be asked to perform a less thermogenic activity noting the cue Children will then cross over so that each child will complete both conditions Primary outcome measures for question a will be changes in energy expenditure when subjects are asked to fidget in a laboratory environment The correlation of these energy expenditure measurements with new activity monitoring technologies will also be obtained so that such equipment can be used for measurements under free-living conditions For study questions b and c compliance with prescribed fidgeting regimens in a free living environment and the changes in energy expenditure and body composition will be determined over a 2 week interval This pilot study will enable the determination of the sample size needed to assess the efficacy of a longer term NEAT intervention in children

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
06-CH-0141 None None None