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Assessment of an Intervention to Prevent Obesity and Diabetes in Latino Farm Workers (Pasos)

11. maj 2017 opdateret af: University of California, Davis

Pasos Saludables: A Pilot Intervention to Prevent Obesity and Diabetes Among Latino Farm Workers

This is a study to assess the effectiveness of a culturally appropriate behavioral intervention to reduce obesity levels and ultimately the risk of developing diabetes type II in immigrant Latino farm workers. Workers enrolled in a 2:1 ratio by random allocation into an intervention or control arm of the study. The intervention participants received weekly classes for 10 weeks with education on diabetes, diet and physical activity and practical exercises. Both control and intervention were measured for weight, waist circumference, fasting blood glucose and interviewed before and after the study intervention. The main hypothesis was that intervention, but not control participants, would experience reduction in body measurements after the intervention.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A more detailed description is not desired as noted above.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

254

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Oxnard, California, Forenede Stater, 93030
        • Reiter Affiliated Companies
      • Watsonville, California, Forenede Stater, 95076
        • Reiter Affiliated Companies

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

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Aged 18 -60
  • BMI between 20 -38
  • Willing to attend 10 weekly education sessions
  • Able to speak and understand Spanish
  • Have medical insurance

Exclusion Criteria:

  • Fasting blood glucose about 126mg/dL unless physician attests fit to participate
  • Pregnancy or trying to conceive, or breastfeeding
  • Diabetic
  • On therapeutic diets
  • On medications that affect weight
  • If spouse / cohabitant already in the study
  • Not a farm worker working for the Reiter Affiliated Companies

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Behavioral intervention
Behavioral intervention consisting of 10 educational sessions promoting healthy diet and increased physical activity.
Adfærdsmæssigt: Behavioral Intervention
Intervention participants attended up to 10 educational sessions teaching them about diabetes, and modifiable lifestyle factors (behaviors) to reduce the risk of diabetes by controlling weight. Sessions were conducted by Promotoras using culturally sensitive and appropriate materials and themes. Group activities and support were also emphasized. The control participants like the intervention were measured and interviewed before and again after the intervention sessions, but received no educational instruction or materials.
Andre navne:
  • Sund livsstilsintervention
  • Kost og fysisk aktivitet intervention
Aktiv komparator: Control
Control arm received no behavioral intervention
Adfærdsmæssigt: Behavioral Intervention
Intervention participants attended up to 10 educational sessions teaching them about diabetes, and modifiable lifestyle factors (behaviors) to reduce the risk of diabetes by controlling weight. Sessions were conducted by Promotoras using culturally sensitive and appropriate materials and themes. Group activities and support were also emphasized. The control participants like the intervention were measured and interviewed before and again after the intervention sessions, but received no educational instruction or materials.
Andre navne:
  • Sund livsstilsintervention
  • Kost og fysisk aktivitet intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in BMI
Tidsramme: Before intervention and after (12-14 weeks after first assessment)
Weight and Height assessed for both control and intervention participants before intervention program and then assessed 2-3 weeks after the intervention period completed.
Before intervention and after (12-14 weeks after first assessment)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Waist Circumference
Tidsramme: Measured before and after intervention (12 - 13 weeks after first assessment
Waist circumference measured in both control and intervention participants using a standard protocol. Conducted before intervention started and again 2-3 weeks after the intervention sessions finished.
Measured before and after intervention (12 - 13 weeks after first assessment

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in fasting blood glucose
Tidsramme: Measured before intervention and after (12-13 weeks after first assessment)
Fasting blood glucose was a voluntary assessment and therefore not conducted in all participants. Blood glucose was assessed from a middle digit using a sterile lancet and Accu-Check Advantage Blood Glucose Meter. It was assessed before the start of the intervention and after completion in both controls and intervention participants.
Measured before intervention and after (12-13 weeks after first assessment)

Samarbejdspartnere og efterforskere

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

Sponsor

University of California, Davis

Efterforskere

  • Ledende efterforsker: Marc B Schenker, MD, University of California, Davis

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. april 2010

Primær færdiggørelse (Faktiske)

1. februar 2011

Studieafslutning (Faktiske)

1. april 2011

Datoer for studieregistrering

Først indsendt

8. maj 2013

Først indsendt, der opfyldte QC-kriterier

13. maj 2013

Først opslået (Skøn)

16. maj 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 219631
  • S-MSPREIT (Anden identifikator: UC Davis)

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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Placeringer

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