- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03182621
Comprehensive Versus Traditional Lifestyle Program
7. juni 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
105
Fase
- Ikke anvendelig
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
8 år til 12 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
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.
|
traditional YMCA program
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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)
1. januar 2014
Primær færdiggørelse (Faktiske)
1. august 2014
Studieafslutning (Faktiske)
1. august 2014
Datoer for studieregistrering
Først indsendt
1. juni 2017
Først indsendt, der opfyldte QC-kriterier
7. juni 2017
Først opslået (Faktiske)
9. juni 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. juni 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. juni 2017
Sidst verificeret
1. juni 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 20120486
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med THINK
-
Queen's University, BelfastWellcome TrustAfsluttetSubjektiv kognitiv svækkelseDet Forenede Kongerige
-
Case Comprehensive Cancer CenterAfsluttetDe formidlende effekter af decentrering på selvstyring af stress og planlægning af livets afslutningFase IV Gastrointestinal kræft | Avanceret gynækologisk kræftForenede Stater