Assessment of an Intervention to Prevent Obesity and Diabetes in Latino Farm Workers (Pasos)
11. mai 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
A more detailed description is not desired as noted above.
Studietype
Intervensjonell
Registrering (Faktiske)
254
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
Oxnard, California, Forente stater, 93030
- Reiter Affiliated Companies
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Watsonville, California, Forente stater, 95076
- Reiter Affiliated Companies
-
-
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
18 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
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: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Behavioral intervention
Behavioral intervention consisting of 10 educational sessions promoting healthy diet and increased physical activity.
|
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 navn:
|
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Aktiv komparator: Control
Control arm received no 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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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Before intervention and after (12-14 weeks after first assessment)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Waist Circumference
Tidsramme: Measured before and after intervention (12 - 13 weeks after first assessment
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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.
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Measured before and after intervention (12 - 13 weeks after first assessment
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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Measured before intervention and after (12-13 weeks after first assessment)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Marc B Schenker, MD, University of California, Davis
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.
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. april 2010
Primær fullføring (Faktiske)
1. februar 2011
Studiet fullført (Faktiske)
1. april 2011
Datoer for studieregistrering
Først innsendt
8. mai 2013
Først innsendt som oppfylte QC-kriteriene
13. mai 2013
Først lagt ut (Anslag)
16. mai 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. mai 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mai 2017
Sist bekreftet
1. mai 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 219631
- S-MSPREIT (Annen identifikator: UC Davis)
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