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- Registre américain des essais cliniques
- Essai clinique NCT03611296
Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids) Fitness Ancillary
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Louisiana
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Baton Rouge, Louisiana, États-Unis, 70808
- Pennington Biomedical Research Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Baseline cardiorespiratory fitness
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Baseline inhibitory control
Délai: 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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Baseline body composition
Délai: Year 0
|
In the TIGER Kids primary study, body composition is measured using whole-body dual-energy x-ray absorptiometry (DXA).
|
Year 0
|
Change in body composition over 2 years
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: S. Nicole Fearnbach, PhD, Pennington Biomedical Research Center
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2017-009
- 5T32DK064584-15 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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