Non-exercise Activity ThermogenesisPhase 1NCT00315172
Non-Exercise Activity Thermogenesis (NEAT) in Children
A Phase 1 study testing Non-Exercise Activity Thermogenesis (NEAT) in people with Non-exercise Activity Thermogenesis, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-exercise Activity Thermogenesis
- What is being tested?
- Non-Exercise Activity Thermogenesis (NEAT)
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2006to 7 Nov 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Volunteers will qualify if they meet the following criteria:
- Good general health. Individuals taking medications for any serious medical condition will be excluded.
- Age 7 to 11 years.
- Body Mass Index 15th to 85th percentile for lean children or greater than or equal to 95% for age for overweight children.
- Pre-pubertal (breast Tanner I - III for girls, testes size less than or equal to 10 mL for boys).
Who cannot join
- Volunteers will be excluded for the following reasons:
- Presence of major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, untreated hyper- or hypothyroidism), hematological problems or pulmonary disorders.
- Taking any medications that might interfere with weight or growth such as oral steroids, or psychotropic agents.
- Presence of movement or tic disorders, since conditions increasing involuntary movements may interfere with the measurement of NEAT.
- Individuals who are taking and/or have taken stimulant or weight loss medications in the last 6 months.
- 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).
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- Intentional weight loss of more than 3 percent of body weight in the past two months.
- 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.
- 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).
- Inability to tolerate study procedures at the screening visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read the 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.
- Conditions
- Non-exercise Activity Thermogenesis
- Being tested
- Non-Exercise Activity Thermogenesis (NEAT)
- Keywords
- Adipose Tissue, Weight Gain, Pediatric, Body Composition, Thermogenesis, Exercise, Healthy Volunteer, HV
- Medical subject headings
- Weight Gain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Exercise Activity Thermogenesis (NEAT)Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study start13 Apr 2006
- Study completion7 Nov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-exercise Activity ThermogenesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315172
- Sponsor's protocol ID
- 060141
- Other IDs
- 06-CH-0141
- Status last verified
- 7 Nov 2008
- First submitted
- 15 Apr 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. doi: 10.1001/jama.291.23.2847.
PubMed 15199035Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002 Oct 9;288(14):1728-32. doi: 10.1001/jama.288.14.1728.
PubMed 12365956Sorof JM, Lai D, Turner J, Poffenbarger T, Portman RJ. Overweight, ethnicity, and the prevalence of hypertension in school-aged children. Pediatrics. 2004 Mar;113(3 Pt 1):475-82. doi: 10.1542/peds.113.3.475.
PubMed 14993537Manoli I, Sysol JR, Head PE, Epping MW, Gavrilova O, Crocker MK, Sloan JL, Koutsoukos SA, Wang C, Ktena YP, Mendelson S, Pass AR, Zerfas PM, Hoffmann V, Vernon HJ, Fletcher LA, Reynolds JC, Tsokos MG, Stratakis CA, Voss SD, Chen KY, Brown RJ, Hamosh A, Berry GT, Chen XS, Yanovski JA, Venditti CP. Lipodystrophy in methylmalonic acidemia associated with elevated FGF21 and abnormal methylmalonylation. JCI Insight. 2024 Feb 22;9(4):e174097. doi: 10.1172/jci.insight.174097.
PubMed 38271099
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Exercise Activity Thermogenesis (NEAT) in Children
- ClinicalTrials.gov ID
- NCT00315172
- Acronym / sponsor ID
- 060141
- Conditions
- Non-exercise Activity Thermogenesis
- Keywords
- Adipose Tissue, Weight Gain, Pediatric, Body Composition, Thermogenesis, Exercise, Healthy Volunteer, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 13 Apr 2006
- Study completion
- 7 Nov 2008
- First posted
- 17 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Good general health. Individuals taking medications for any serious medical condition will be excluded.
- Age 7 to 11 years.
- Body Mass Index 15th to 85th percentile for lean children or greater than or equal to 95% for age for overweight children.
- Pre-pubertal (breast Tanner I - III for girls, testes size less than or equal to 10 mL for boys).
Key exclusion criteria (10 listed)
- Presence of major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, untreated hyper- or hypothyroidism), hematological problems or pulmonary disorders.
- Taking any medications that might interfere with weight or growth such as oral steroids, or psychotropic agents.
- Presence of movement or tic disorders, since conditions increasing involuntary movements may interfere with the measurement of NEAT.
- Individuals who are taking and/or have taken stimulant or weight loss medications in the last 6 months.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Exercise Activity Thermogenesis (NEAT) | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 15199035Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. doi: 10.1001/jama.291.23.2847.
- Background: PubMed 12365956Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002 Oct 9;288(14):1728-32. doi: 10.1001/jama.288.14.1728.
- Background: PubMed 14993537Sorof JM, Lai D, Turner J, Poffenbarger T, Portman RJ. Overweight, ethnicity, and the prevalence of hypertension in school-aged children. Pediatrics. 2004 Mar;113(3 Pt 1):475-82. doi: 10.1542/peds.113.3.475.
- Derived from this study: PubMed 38271099Manoli I, Sysol JR, Head PE, Epping MW, Gavrilova O, Crocker MK, Sloan JL, Koutsoukos SA, Wang C, Ktena YP, Mendelson S, Pass AR, Zerfas PM, Hoffmann V, Vernon HJ, Fletcher LA, Reynolds JC, Tsokos MG, Stratakis CA, Voss SD, Chen KY, Brown RJ, Hamosh A, Berry GT, Chen XS, Yanovski JA, Venditti CP. Lipodystrophy in methylmalonic acidemia associated with elevated FGF21 and abnormal methylmalonylation. JCI Insight. 2024 Feb 22;9(4):e174097. doi: 10.1172/jci.insight.174097.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Non-Exercise Activity Thermogenesis (NEAT) in people with Non-exercise Activity Thermogenesis, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00315172, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.