Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids) Fitness Ancillary
15 juni 2022 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
30
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Louisiana
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Baton Rouge, Louisiana, Verenigde Staten, 70808
- Pennington Biomedical Research Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
10 jaar tot 16 jaar (Kind)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Baseline cardiorespiratory fitness
Tijdsspanne: 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
Tijdsspanne: 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
|
|
Baseline energy intake
Tijdsspanne: 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.
|
Year 0
|
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Change in energy intake over 2 years
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Baseline inhibitory control
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
|
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Baseline appetite-related Visual Analog Scales (VAS)
Tijdsspanne: 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
Tijdsspanne: 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 uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Baseline body composition
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
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Change in activity patterns over 2 years
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: S. Nicole Fearnbach, PhD, Pennington Biomedical Research Center
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
6 juni 2017
Primaire voltooiing (Werkelijk)
18 augustus 2020
Studie voltooiing (Werkelijk)
18 augustus 2020
Studieregistratiedata
Eerst ingediend
2 juli 2018
Eerst ingediend dat voldeed aan de QC-criteria
31 juli 2018
Eerst geplaatst (Werkelijk)
2 augustus 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
21 juni 2022
Laatste update ingediend die voldeed aan QC-criteria
15 juni 2022
Laatst geverifieerd
1 juni 2022
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2017-009
- 5T32DK064584-15 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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