- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03611296
Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids) Fitness Ancillary
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Louisiana
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Baton Rouge, Louisiana, Vereinigte Staaten, 70808
- Pennington Biomedical Research Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Baseline cardiorespiratory fitness
Zeitfenster: 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
|
Change in cardiorespiratory fitness over 2 years
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Baseline inhibitory control
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Baseline body composition
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
Year 0
|
Change in activity patterns over 2 years
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: S. Nicole Fearnbach, PhD, Pennington Biomedical Research Center
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2017-009
- 5T32DK064584-15 (US NIH Stipendium/Vertrag)
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