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Comprehensive Versus Traditional Lifestyle Program

7. juni 2017 oppdatert av: Arlette Perry, University of Miami

THINK (Translational Health in Nutrition and Kinesiology) Junior Edition

Despite recommends that school-based interventions use a comprehensive approach for health promotions; most fitness programs exclusively emphasize physical activity. This study compared the comprehensive Translational Health in Nutrition and Kinesiology (THINK) program to a traditional YMCA program (The Sports, Play, and Active Recreation for Kids (SPARK) fitness curriculum) on measures of physical fitness, body composition, and executive cognitive function outcomes among 105 ethnic minority children (9±1.03 years old) following a 10-week intervention period.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Despite recommendations that school-based interventions use a comprehensive approaches for health promotions; most fitness programs exclusively emphasize physical activity. This study compared the comprehensive Translational Health in Nutrition and Kinesiology (THINK) program to a traditional YMCA program (The Sports, Play, and Active Recreation for Kids (SPARK) fitness curriculum) on measures of physical fitness, body composition, and executive cognitive function outcomes among 105 predominantly, ethnic minority children (9±1.03 years old) following a 10week intervention period.

Studietype

Intervensjonell

Registrering (Faktiske)

105

Fase

  • Ikke aktuelt

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

8 år til 12 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • To be eligible for this study, subjects had to be between the ages of eight and 12, enrolled in a YMCA program, and able to participate in physical activity. Parents were provided with information packets regarding project details, a parental consent form, and a child assent form. Once the subjects assented and parents consented, a health questionnaire regarding child's age, gender, race/ethnicity, health history and SES was completed.

Exclusion Criteria:

  • Subjects with metabolic, cardiovascular, neuromuscular and psychological disorders and with medications that would interfere with testing results were excluded from the study.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: THINK
The Translational Health in Nutrition and Kinesiology (THINK) program will have education and fitness sessions lasting two hours, five times a week for a total of 10 weeks. Sessions will include theory, clinical laboratory activities, and physically active games to facilitate a fun environment to enhance physical and health-related fitness, improve nutrition and exercise knowledge and behaviors, and exercise enjoyment and self-confidence.
Atferdsmessig: THINK
The THINK curriculum was based on the principles of exercise physiology and health behaviors. Sessions included educational components, concentrating on physiology, nutrition, laboratory experiences, and structured physical fitness activities.
Aktiv komparator: SPARK
This The Sports, Play, and Active Recreation for Kids (SPARK) group will receive the traditional YMCA SPARK after-school program. They will undergo the same pre and post testing protocol as the intervention group, but will not receive the THINK program.
Atferdsmessig: SPARK
traditional YMCA program

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Aerobic Fitness
Tidsramme: Baseline and 10 Weeks
The National Institute of Medicine Toolbox two-minute Walk Endurance Test was used to measure aerobic fitness
Baseline and 10 Weeks
Change in Grip Strength
Tidsramme: Baseline and 10 Weeks
Grip strength was measures using a Jamar plus handgrip dynamometer.
Baseline and 10 Weeks
Change in Abdominal Strength
Tidsramme: Baseline and 10 Weeks
The one-minute curl-up test was used to measure abdominal strength and endurance.
Baseline and 10 Weeks
Change in Lower Body Strength
Tidsramme: Baseline and 10 Weeks
Lower body strength, specifically for the quadriceps muscle group, was assessed with the wall squat test. A vertical jump test utilizing a Vertec. was used to assess lower body power . The vertical jump test data were used to estimate average power (W) according to the Lewis formula Average Power (W) = √4.9 x mass (kg) x √VJ (m) x 9.81.
Baseline and 10 Weeks
Change in Percent Body Fat
Tidsramme: Baseline and 10 Weeks
Body composition and body fat was measured using the Inbody-520 multi-frequency bioimpedance analyzer.
Baseline and 10 Weeks
Change in BMIz
Tidsramme: Baseline and 10 Weeks
A CDC growth chart statistical resource was used to calculate BMIz using height, weight, age, and gender.
Baseline and 10 Weeks
Change in Visceral Abdominal Fat
Tidsramme: Baseline and 10 Weeks
The Saggital Abdominal Height was used as estimate of visceral abdominal fat using a portable anthropometer.
Baseline and 10 Weeks
Change in Waist circumference
Tidsramme: Baseline and 10 Weeks
Waist circumference was used to measure central adiposity with a Gulick body tape measure.
Baseline and 10 Weeks

Samarbeidspartnere og etterforskere

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

Sponsor

University of Miami

Samarbeidspartnere

University of Tennessee

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)

1. januar 2014

Primær fullføring (Faktiske)

1. august 2014

Studiet fullført (Faktiske)

1. august 2014

Datoer for studieregistrering

Først innsendt

1. juni 2017

Først innsendt som oppfylte QC-kriteriene

7. juni 2017

Først lagt ut (Faktiske)

9. juni 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juni 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juni 2017

Sist bekreftet

1. juni 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 20120486

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Only the study investigators and/or sponsor will monitor the plan for data and safety monitoring for this study. Shared data will be done through encrypted files and file management platform OneDrive.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Netherlands

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere