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

15. juni 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70808
        • Pennington Biomedical Research Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

10 år til 16 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pennington Biomedical Research Center

Samarbejdspartnere

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

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. juni 2017

Primær færdiggørelse (Faktiske)

18. august 2020

Studieafslutning (Faktiske)

18. august 2020

Datoer for studieregistrering

Først indsendt

2. juli 2018

Først indsendt, der opfyldte QC-kriterier

31. juli 2018

Først opslået (Faktiske)

2. august 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juni 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2022

Sidst verificeret

1. juni 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

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