Non-Exercise Activity Thermogenesis (NEAT) in Children

June 30, 2017 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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, children's 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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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, children's 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

Volunteers will qualify if they meet the following criteria:

  1. Good general health. Individuals taking medications for any serious medical condition will be excluded.
  2. Age 7 to 11 years.
  3. Body Mass Index 15th to 85th percentile for lean children or greater than or equal to 95% for age for overweight children.
  4. Pre-pubertal (breast Tanner I - III for girls, testes size less than or equal to 10 mL for boys).

EXCLUSION CRITERIA:

Volunteers will be excluded for the following reasons:

  1. Presence of major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, untreated hyper- or hypothyroidism), hematological problems or pulmonary disorders.
  2. Taking any medications that might interfere with weight or growth such as oral steroids, or psychotropic agents.
  3. Presence of movement or tic disorders, since conditions increasing involuntary movements may interfere with the measurement of NEAT.
  4. Individuals who are taking and/or have taken stimulant or weight loss medications in the last 6 months.
  5. Individuals who cannot commit to living in a similar environment with similar levels of activity during the two weeks they wear the activity monitors and timer (i.e. cannot have one week wearing the activity monitors in school and the other week wearing the activity monitors on a ski vacation).
  6. Intentional weight loss of more than 3 percent of body weight in the past two months.
  7. Weight in excess of 300 lbs, because of the weight limits of the dual energy x-ray absorptiometry (DXA) scanners available at the NIH Clinical Center.
  8. Inability to undergo MRI (e.g., volunteers with metal within their bodies including cardiac pacemakers, neural pacemakers, aneurysmal clips, shrapnel, ocular foreign bodies, cochlear implants, non-detachable electronic or electromechanical devices such as infusion pumps, nerve stimulators, bone growth stimulators, etc. that are contraindications).
  9. Inability to tolerate study procedures at the screening visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2006

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2006

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 7, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 060141
  • 06-CH-0141

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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