- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03885115
Lace Up and Move: Structured After School Intervention for Hispanic and African American Youth (LUAM)
3. april 2019 oppdatert av: Norma Olvera, University of Houston
Lace Up and Move: Structured After School Exercise Intervention for Hispanic and African American Youth
The purpose of this study is to test the efficacy of Lace Up and Move (LUAM), a structured after-school exercise intervention, designed to increase moderate-to-vigorous physical activity (MVPA) and enhance sleep quality among Hispanic and African American (AA) boys and girls.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study uses a randomized comparison-group pre-post-test design.
Overall objectives of LUAM are to: (1) to increase the percentage of youth who meet 60 minutes of daily MVPA per week; (2) to improve the quality of sleep patterns (i.e., sleep efficiency and duration); and (3) to reduce percent body fat (%BF).
It is hypothesized that compared to the control group (CG) participants, the experimental group (EG) participants will exhibit: (a) greater increase in percentage of children who meet 60 minutes of daily MVPA per week; (b) greater increase of sleep efficiency and duration; and (c) greater decrease in sleep latency and (d) greater decrease in %BF.
Studietype
Intervensjonell
Registrering (Forventet)
600
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Texas
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Houston, Texas, Forente stater, 77204
- University of Houston
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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
9 år til 14 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- child and at least their mother [or one member of the family] must be of Hispanic or African American descent
- child must have no physical disability or medical conditions that interfere with their participation in the exercise program
Exclusion Criteria:
- neither child nor parental guardians is of Hispanic or African American descent
- child is not between the ages of 9-14 years
- child is pregnant or physically unable to participate in the exercise program.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Intervention
Participants randomly assigned to the experiential group (EG) will receive a 12-week structured exercise that will consist of two group fitness sessions (i.e.
kickboxing, Zumba, fitness yoga, and other aerobic exercises) every week.
Certified fitness instructors will lead each session and participants will learn strategies how to be more active during the daily routines at home.
Parents or other relatives in the EG will participate in one 2-hour session every four weeks (total of 3 sessions) designed to help them support their children and entire family in being active and eat healthy at home.
Parents will meet with a fitness instructor who will provide specific tips on how to increase physical activity at home as well as providing community resources to be active.
A basic nutrition education and cooking demonstrations, and healthy recipes will be also provided to parents at these workshops.
Data/assessments are collected, pre and post the 12 weeks intervention.
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Involves 12-weeks of education related to healthy behaviors, nutrition, and exercise from certified fitness instructors.
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Ingen inngripen: Control
Participants randomly assigned to the control group (CG) will receive once a week recreational structured group play/game sessions led by trained BOUNCE interns/staff.
The control group will receive 60 minute of structured free play sessions (i.e.
recreational games) once a week for 12 weeks.
Every 4 weeks, parents will be given (either sent home with their child or via email or mail) basic nutrition information, healthy recipes, and tips to promote physical activity at home as well as community resources to be active.
Data/assessments are collected, pre and post the 12 weeks intervention.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Child Physical Activity
Tidsramme: pre & post intervention at Week 12
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measure the percentage of youth who meet 60 minutes of daily moderate-to-vigorous physical activity per week
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pre & post intervention at Week 12
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Sleep
Tidsramme: pre & post intervention at Week 12
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assess using self-report survey
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pre & post intervention at Week 12
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Sleep Quality
Tidsramme: pre & post intervention at Week 12
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assess quality of sleep patterns using a small motion analyzer that measures sleep efficiency, duration and latency
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pre & post intervention at Week 12
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Body fat percentage
Tidsramme: pre & post intervention at Week 12
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percent body fat obtained from a foot-to-foot bio-electrical impedance assessment
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pre & post intervention at Week 12
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Norma Olvera, University of Houston
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)
28. november 2017
Primær fullføring (Forventet)
1. desember 2019
Studiet fullført (Forventet)
1. mai 2020
Datoer for studieregistrering
Først innsendt
19. mars 2019
Først innsendt som oppfylte QC-kriteriene
19. mars 2019
Først lagt ut (Faktiske)
21. mars 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. april 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. april 2019
Sist bekreftet
1. april 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00000392
Plan for individuelle deltakerdata (IPD)
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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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