- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03611296
Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids) Fitness Ancillary
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
The investigators will enroll 30 boys and girls (50% female) between the ages of 10-16 years and above the 85th BMI percentile (i.e., overweight to severe obesity) in this pilot ancillary study. The objective is to examine interactions between the following energy-balance related factors:
- Ad libitum post-exercise food intake
- Cognitive factors, including inhibitory control, food wanting, and motivation for food
- Exercise-related factors, including cardiorespiratory fitness, substrate utilization (carbohydrate versus fat), and perceived exertion
- Habitual physical and sedentary activity
- Body composition and cardiometabolic health
The prospective, longitudinal nature of the study will allow the investigators to examine these variables cross-sectionally and quantify change over two years. Of particular interest is whether cognitive factors related to energy balance, including perceived exertion, inhibitory control, food wanting, and food motivation, vary across time or are relatively stable. Finally, the investigators will assess the ability of these factors to predict changes in body composition and cardiometabolic health over two years.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Louisiana
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Baton Rouge, Louisiana, Stati Uniti, 70808
- Pennington Biomedical Research Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Eligible for the TIGER Kids primary study
- BMI >/= 85th percentile
- Height >/= 4 feet 6 inches
- Weight < 350 pounds
Exclusion Criteria:
- Anemia
- American College of Sports Medicine (ACSM) contraindications to exercise testing (i.e., medical history of cardiovascular or pulmonary conditions, physical conditions that affect the ability to exercise)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Baseline cardiorespiratory fitness
Lasso di tempo: Year 0
|
Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.
|
Year 0
|
Change in cardiorespiratory fitness over 2 years
Lasso di tempo: Year 0 and Year 2
|
Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.
|
Year 0 and Year 2
|
Baseline energy intake
Lasso di tempo: Year 0
|
Ad libitum energy intake in kilocalories is measured using a in-laboratory dinner test-meal.
Participants can eat as much or as little as they would like from the available food, which is provided in excess of energy needs.
|
Year 0
|
Change in energy intake over 2 years
Lasso di tempo: Year 0 and Year 2
|
Ad libitum energy intake in kilocalories is measured using a in-laboratory dinner test-meal.
Participants can eat as much or as little as they would like from the available food, which is provided in excess of energy needs.
|
Year 0 and Year 2
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Baseline inhibitory control
Lasso di tempo: Year 0
|
Inhibitory control is measured using a Go/No-go behavioral task administered on a computer.
Errors, false alarms, and reaction times are collected for various conditions: baseline, food rewards (favorite snack and least favorite snack from a selected list of options) and neutral control (unrewarded).
|
Year 0
|
Change in inhibitory control over 2 years
Lasso di tempo: Year 0 and Year 2
|
Inhibitory control is measured using a Go/No-go behavioral task administered on a computer.
Errors, false alarms, and reaction times are collected for various conditions: baseline, food rewards (favorite snack and least favorite snack from a selected list of options) and neutral control (unrewarded).
|
Year 0 and Year 2
|
Baseline Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2)
Lasso di tempo: Year 0
|
The Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2) consists of three appetite-related subscales: Cognitive Restraint, Emotional Eating, and Uncontrolled Eating.
Subscales are scored on a range from 0-100, with higher scores representing higher levels of that construct.
|
Year 0
|
Change in Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2) over 2 years
Lasso di tempo: Year 0 and Year 2
|
The Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2) consists of three appetite-related subscales: Cognitive Restraint, Emotional Eating, and Uncontrolled Eating.
Subscales are scored on a range from 0-100, with higher scores representing higher levels of that construct.
|
Year 0 and Year 2
|
Baseline appetite-related Visual Analog Scales (VAS)
Lasso di tempo: Year 0
|
The following constructs are measured before and after the fitness test and before and after the dinner test-meal: Hunger, fullness, desire to eat, prospective food consumption, satisfaction, and wanting for specific foods (age-appropriate and commonly consumed foods for this population).
VAS scores range from 0-100, with higher scores representing higher levels of that construct.
|
Year 0
|
Change in appetite-related Visual Analog Scales (VAS) over 2 years
Lasso di tempo: Year 0 and Year 2
|
The following constructs are measured before and after the fitness test and before and after the dinner test-meal: Hunger, fullness, desire to eat, prospective food consumption, satisfaction, and wanting for specific foods (age-appropriate and commonly consumed foods for this population).
VAS scores range from 0-100, with higher scores representing higher levels of that construct.
|
Year 0 and Year 2
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Baseline body composition
Lasso di tempo: Year 0
|
In the TIGER Kids primary study, body composition is measured using whole-body dual-energy x-ray absorptiometry (DXA).
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Year 0
|
Change in body composition over 2 years
Lasso di tempo: Year 0 and Year 2
|
In the TIGER Kids primary study, body composition is measured using whole-body dual-energy x-ray absorptiometry (DXA).
|
Year 0 and Year 2
|
Baseline activity patterns
Lasso di tempo: Year 0
|
In the TIGER Kids primary study, activity is measured for 24 hours per day over 7 consecutive days, including 2 weekend days, using ActiGraph GT3X+ accelerometers worn on the left mid-axillary line.
|
Year 0
|
Change in activity patterns over 2 years
Lasso di tempo: Year 0 and Year 2
|
In the TIGER Kids primary study, activity is measured for 24 hours per day over 7 consecutive days, including 2 weekend days, using ActiGraph GT3X+ accelerometers worn on the left mid-axillary line.
|
Year 0 and Year 2
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: S. Nicole Fearnbach, PhD, Pennington Biomedical Research Center
Pubblicazioni e link utili
Pubblicazioni generali
- Fearnbach SN, Johannsen NM, Martin CK, Katzmarzyk PT, Beyl RA, Hsia DS, Carmichael OT, Staiano AE. A Pilot Study of Cardiorespiratory Fitness, Adiposity, and Cardiometabolic Health in Youth With Overweight and Obesity. Pediatr Exerc Sci. 2020 Apr 25;32(3):124-131. doi: 10.1123/pes.2019-0192.
- Fearnbach N, Staiano AE, Johannsen NM, Hsia DS, Beyl RA, Carmichael OT, Martin CK. Predictors of Post-Exercise Energy Intake in Adolescents Ranging in Weight Status from Overweight to Severe Obesity. Nutrients. 2022 Jan 5;14(1):223. doi: 10.3390/nu14010223.
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2017-009
- 5T32DK064584-15 (Sovvenzione/contratto NIH degli Stati Uniti)
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