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Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids) Fitness Ancillary

15. juni 2022 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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:

  1. Ad libitum post-exercise food intake
  2. Cognitive factors, including inhibitory control, food wanting, and motivation for food
  3. Exercise-related factors, including cardiorespiratory fitness, substrate utilization (carbohydrate versus fat), and perceived exertion
  4. Habitual physical and sedentary activity
  5. 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

Observasjonsmessig

Registrering (Faktiske)

30

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Louisiana
      • Baton Rouge, Louisiana, Forente stater, 70808
        • Pennington Biomedical Research Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

10 år til 16 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Baseline cardiorespiratory fitness
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Baseline inhibitory control
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Baseline body composition
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pennington Biomedical Research Center

Samarbeidspartnere

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Etterforskere

  • Hovedetterforsker: S. Nicole Fearnbach, PhD, Pennington Biomedical Research Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. juni 2017

Primær fullføring (Faktiske)

18. august 2020

Studiet fullført (Faktiske)

18. august 2020

Datoer for studieregistrering

Først innsendt

2. juli 2018

Først innsendt som oppfylte QC-kriteriene

31. juli 2018

Først lagt ut (Faktiske)

2. august 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. juni 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juni 2022

Sist bekreftet

1. juni 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2017-009
  • 5T32DK064584-15 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

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NEI

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Nei

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