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Ethnic Dance and Screen Time Reduction to Prevent Weight Gain in Latina Girls (ECHALE)

12. december 2012 opdateret af: Stanford University
A randomized controlled trial to test the efficacy of an after school ethnic dance program plus a culturally-tailored, home-based screen time reduction intervention to reduce weight gain (body mass index) among lower socioeconomic status, pre-adolescent Latina girls.

Studieoversigt

Detaljeret beskrivelse

We propose a 2-arm, parallel group, randomized controlled trial to test the efficacy of an after school ethnic dance program plus a culturally-tailored, home-based screen time reduction intervention to reduce weight gain (body mass index) among lower socioeconomic status, pre-adolescent Latina girls. The control group will receive an "active-placebo" information-based health education intervention. A total of 240 7-9 year old girls will be randomized to the two conditions, and both interventions will last for the full 2-year period of the study for each girl.

Latina girls are at increased risk of obesity and obesity-related morbidities. However, effective and generalizable obesity prevention programs for this rapidly growing population are not available. After school ethnic dance programs are highly motivating, and an innovative approach to providing a large "dose" of moderate-to-vigorous physical activity for Latina girls. After school programs may also indirectly reduce sedentary behavior and improve diet. Dance is fun for pre-adolescent girls, it plays an important social and cultural role in Latino communities, and after school dance classes are a potentially generalizable "environmental" intervention strategy. Our past pilot studies and ongoing trials of ethnic dance interventions demonstrate that (1) dance is a highly attractive and feasible form of activity for pre-adolescent girls and (2) a dance intervention can result in reduced weight gain (BMI) and increased fitness among girls.

Latina girls are also heavy consumers of screen-based media, television, videotapes/DVDs and video games. Excessive screen time is considered one of the most modifiable causes of childhood obesity. We propose a culturally-tailored, home-based screen time reduction intervention, delivered by bilingual, Latina, Community Health Advisors (CHAs). Our prior and ongoing studies demonstrate the feasibility and potential efficacy of (1) reducing children's screen time to reduce weight gain and (2) providing home-based behavior change interventions to low-income Latino families using CHAs. All interventions will be further developed, revised, and pilot-tested with Latina girls and their families through formative research.

240 girls Latina girls will be recruited over 18 months from six public elementary schools serving low-income Latino communities in northern CA. Measures will be collected in girls' homes at baseline, 6, 12, 18 and 24 months, including height and weight, waist circumference, triceps skinfold thickness, blood pressure and resting heart rate, physical activity monitoring by accelerometry, media use, 24-hour dietary recalls, weight concerns, depressive symptoms, school performance, sexual maturation, and demographics. Body Mass Index (BMI) is the primary outcome measure. The primary outcome analysis will compare individual trajectories of change in BMI in the treatment and control groups over the entire two-year course of the trial, using random regression models. The study is powered (90%) to detect a clinically-significant effect. Specific Aims include:

  1. To test the efficacy of a combined, after school ethnic dance and home-based screen time reduction intervention to reduce weight gain (BMI) over 2 years.

    Primary hypothesis: Compared to controls, girls in the treatment group will significantly reduce their weight gain (BMI) over the two-year study period.

  2. To test the effects of a combined, after school ethnic dance and home-based screen time reduction intervention on secondary outcomes over two years.

    Secondary hypotheses: Compared to controls, girls in the treatment group will significantly reduce their waist circumference, triceps skinfold thickness, systolic and diastolic resting blood pressures, resting heart rate, television, videotape/DVD and video game use, meals eaten with TV, daily dietary energy intake, percent of energy from fat, weight concerns and depressive symptoms, and significantly increase their daily physical activity, daily moderate to vigorous physical activity, liking for physical activity, and school performance.

  3. To evaluate potential demographic, cultural, psychological, and biological moderators and mediators of intervention effects on BMI and secondary outcomes, to evaluate correlates and risk factors for change in BMI and secondary outcomes, and to evaluate intervention delivery variables and their relationships to outcomes.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

233

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • California
      • Stanford, California, Forenede Stater, 94305
        • Stanford Prevention 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

7 år til 9 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Defined as Latina or Hispanic by parent/guardian.
  • Attends one of the participating public elementary schools.

Exclusion Criteria:

  • Diagnosed with a medical condition affecting growth.
  • Taking medications affecting growth.
  • A condition limiting participation in the interventions.
  • A condition limiting participation in the assessments.
  • Plan to move from the area within the next 24 months.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: After school ethnic dance and home-based screen time reduction
After school ethnic dance classes and home-based screen time reduction intervention
Aktiv komparator: Health and Nutrition Education
Health and nutrition education active placebo control intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Body Mass Index (BMI)
Tidsramme: change over 2 years
change over 2 years

Sekundære resultatmål

Resultatmål
Tidsramme
waist circumference
Tidsramme: over 2 years
over 2 years
triceps skinfold thickness
Tidsramme: over 2 years
over 2 years
systolic and diastolic resting blood pressures
Tidsramme: over 2 years
over 2 years
resting heart rate
Tidsramme: over 2 years
over 2 years
screen time
Tidsramme: over 2 years
over 2 years
meals eaten with television
Tidsramme: over 2 years
over 2 years
average dietary energy intake and percent of energy from fat
Tidsramme: over 2 years
over 2 years
average daily total physical activity and moderate-to-vigorous physical activity
Tidsramme: over 2 years
over 2 years
weight concerns
Tidsramme: over 2 years
over 2 years

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Thomas N Robinson, M.D., M.P.H., Stanford University

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

1. maj 2007

Primær færdiggørelse (Faktiske)

1. marts 2011

Studieafslutning (Faktiske)

1. august 2012

Datoer for studieregistrering

Først indsendt

18. maj 2007

Først indsendt, der opfyldte QC-kriterier

18. maj 2007

Først opslået (Skøn)

22. maj 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. december 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. december 2012

Sidst verificeret

1. december 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R01DK073006 (U.S. NIH-bevilling/kontrakt)
  • SPO 33483 (Anden identifikator: Stanford University)

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 .

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