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Challenge! Adolescent Obesity Prevention (Challenge)

14. august 2019 oppdatert av: Maureen Black, University of Maryland, Baltimore

Challenge! in Baltimore City Middle Schools

The prevalence of overweight among adolescents (BMI-for-age %tile over the 95th percentile) has more than tripled over the past 3 decades in the US. Overweight and physical inactivity disproportionately affect low- income, female, African American adolescents.

A prior health-promotion/ obesity-prevention program for adolescents developed and tested by our group (Challenge!) showed that adolescents who received the intervention were less likely to become overweight or obese over 2 years when compared to the control group. This intervention was administered one-on-one to adolescents in their homes or community by a college-aged mentor.

Schools are an ideal setting for interventions because the effect can be far-reaching and sustainable. School-based obesity-prevention interventions have thus far shown modest results.

The purpose of this study is to evaluate the impact of a multilevel intervention that includes both the Challenge program administered in a small group format after school using mentors and teachers and a school-wide environmental change on adolescent females' body composition, diet, and physical activity. The intervention is targeted to 6th and 7th grade female students. The small group intervention is conducted over 12 weeks and includes goal setting focusing on healthy diet and physical activity, along with membership and weekly trips to the YMCA. The environmental intervention includes a Health and Activity Committee (HAC), comprised of 8th grade female students (popular opinion leaders), school personnel, parents, and community members. The HAC develops school-wide health promotion messages and activities. Parents of participating 6th and 7th grade girls provide information on family variables. The hypotheses are that females who receive the small group or environmental intervention are at less risk of weight gain (overweight) than females in the control small group condition, that females in environmental schools are at less risk of weight gain (overweight) than females in the control environmental condition, and that females who receive both the small group and environmental intervention are at the lower risk of weight gain (overweight) than females who receive only the environmental or small group intervention or neither intervention.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

789

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201
        • Baltimore City Public Schools

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 og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

For small group intervention:

  • Female Adolescent
  • Grades 6 or 7
  • No health problems that would interfere with participation in physical education classes

For environmental intervention Health and Activity Committee:

Must be one of the following:

  • 8th grade female student
  • Parent or legal guardian of any student in the school
  • School personnel
  • Adult Community member (Self-identifies as member of specified community surrounding school)

Exclusion Criteria:

For small group intervention:

  • Male
  • Outside of the grade range 6-7 at recruitment
  • Participant will be excluded if they answer no to question 1 on the screening questionnaire (unable to read and understand questions written in English)
  • Participant will be excluded if they answer yes to questions 2 or 3 on screening form (fails health screening due to medical condition preventing them from engaging in physical activity)

For environmental intervention Health and Activity Committee:

  • Inability to speak or read English
  • Inability to attend meetings

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: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Challenge! Small Group Intervention only

This group receives the Challenge! Small Group intervention consisting of curriculum related to health behavior goal setting, healthy eating, and staying active, works out with their Health Educators, and receives a year-long membership to the YMCA.

This group is in schools that were randomly assigned to NOT receive the Environmental Intervention.
Atferdsmessig: Challenge! Small Group Intervention
The Challenge! Small Group intervention consists of curriculum related to health behavior goal setting, healthy eating, and staying active, working out with Health Educators, and receiving a year-long membership to the YMCA.
Eksperimentell: Challenge! Small Group and Environmental Intervention

This group consists of participants who receive the Challenge! Small Group Intervention AND attend a school that is randomly assigned to receive an environmental intervention.

This group receives the Challenge! Small Group intervention consisting of curriculum related to health behavior goal setting, healthy eating, and staying active, works out with their Health Educators, and receives a year-long membership to the YMCA.

The environmental intervention involves the formation of a Health and Activity Committee composed of community members, teachers, parents, school staff, and 8th grade girls from the school. Together, this group comes up with ways to make their school environment healthier.
Atferdsmessig: Challenge! Small Group Intervention
The Challenge! Small Group intervention consists of curriculum related to health behavior goal setting, healthy eating, and staying active, working out with Health Educators, and receiving a year-long membership to the YMCA.
Annen: Challenge! Environmental Intervention
The environmental intervention involves the formation of a Health and Activity Committee composed of community members, teachers, parents, school staff, and 8th grade girls from the school. Together, this group comes up with ways to make their school environment healthier.
Eksperimentell: Environmental Intervention Only

This group consists of participants who do not receive the Challenge! Small Group Intervention but attend a school that is randomly assigned to receive an environmental intervention.

This group does not receive the Challenge! Small Group Intervention.

The environmental intervention involves the formation of a Health and Activity Committee composed of community members, teachers, parents, school staff, and 8th grade girls from the school. Together, this group comes up with ways to make their school environment healthier.
Annen: Challenge! Environmental Intervention
The environmental intervention involves the formation of a Health and Activity Committee composed of community members, teachers, parents, school staff, and 8th grade girls from the school. Together, this group comes up with ways to make their school environment healthier.
Ingen inngripen: Control Group
This group does not receive the Challenge! Small Group intervention and is in a school that is randomly assigned to NOT have the Environmental Intervention.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change of Body Mass Index Percentile for Age and Sex for adolescent females
Tidsramme: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change of Dietary Quality for adolescent females
Tidsramme: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
Dietary quality will be assessed via the use of a Food Frequency Questionnaire.
Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

Samarbeidspartnere og etterforskere

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

Sponsor

University of Maryland, Baltimore

Samarbeidspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Johns Hopkins Bloomberg School of Public Health
Robert Wood Johnson Foundation

Etterforskere

  • Hovedetterforsker: Maureen M Black, PhD, University of Maryland School of Medicine, Department of Pediatrics, Growth & Nutrition Division

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

1. september 2009

Primær fullføring (Faktiske)

1. januar 2014

Studiet fullført (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først innsendt

2. april 2010

Først innsendt som oppfylte QC-kriteriene

31. mars 2017

Først lagt ut (Faktiske)

6. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. august 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. august 2019

Sist bekreftet

1. august 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HP-00040540
  • R01HD054727 (U.S. NIH-stipend/kontrakt)

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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