Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids) Fitness Ancillary
15 de junio de 2022 actualizado por: S. Nicole Fearnbach, Pennington Biomedical Research Center
The purpose of this ancillary study is to examine cardiorespiratory fitness, cognitive factors related to appetite, and objectively-measured food intake in a subsample of children and adolescents with overweight to severe obesity enrolled in the TIGER Kids prospective cohort.
The primary study also collects data on habitual physical and sedentary activity, body weight and body composition, and cardiometabolic health markers.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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 de estudio
De observación
Inscripción (Actual)
30
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70808
- Pennington Biomedical Research Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
10 años a 16 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
This study will identify and recruit 30 participants from the TIGER Kids primary study sample of 340 participants.
Ancillary participants will be between the ages of 10-16 years and above the 85th age- and sex-specific BMI percentile (i.e., overweight to severe obesity).
We will have an even distribution of boys (n=15) and girls (n=15) and aim to have a representative distribution of race.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Baseline cardiorespiratory fitness
Periodo de tiempo: Year 0
|
Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.
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Year 0
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Change in cardiorespiratory fitness over 2 years
Periodo de tiempo: Year 0 and Year 2
|
Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.
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Year 0 and Year 2
|
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Baseline energy intake
Periodo de tiempo: Year 0
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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.
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Year 0
|
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Change in energy intake over 2 years
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Baseline inhibitory control
Periodo de tiempo: 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).
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Year 0
|
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Change in inhibitory control over 2 years
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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Year 0
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Change in Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2) over 2 years
Periodo de tiempo: 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.
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Year 0 and Year 2
|
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Baseline appetite-related Visual Analog Scales (VAS)
Periodo de tiempo: 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.
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Year 0
|
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Change in appetite-related Visual Analog Scales (VAS) over 2 years
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Baseline body composition
Periodo de tiempo: 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
Periodo de tiempo: 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
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Baseline activity patterns
Periodo de tiempo: Year 0
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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.
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Year 0
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Change in activity patterns over 2 years
Periodo de tiempo: 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.
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Year 0 and Year 2
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: S. Nicole Fearnbach, PhD, Pennington Biomedical Research Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
6 de junio de 2017
Finalización primaria (Actual)
18 de agosto de 2020
Finalización del estudio (Actual)
18 de agosto de 2020
Fechas de registro del estudio
Enviado por primera vez
2 de julio de 2018
Primero enviado que cumplió con los criterios de control de calidad
31 de julio de 2018
Publicado por primera vez (Actual)
2 de agosto de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de junio de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
15 de junio de 2022
Última verificación
1 de junio de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2017-009
- 5T32DK064584-15 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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