Physical Activity and Education Program for Somali Women
11. mai 2016 oppdatert av: Kate Murray, PhD, MPH, University of California, San Diego
Physical Activity and Education to Reduce Cancer Risk Among Somali Women (Ladnaan Project)
There is a significant need for culturally adapted and effective health education programs to address rising rates of obesity and chronic disease concerns for refugee communities.
Physical activity has been identified as an important prevention tool to prevent numerous chronic health conditions.
This research tests the feasibility and acceptability of a culturally adapted physical activity intervention for sedentary adult Somali women.
Study participants will be randomized to a 3-month physical activity program or a wait-list control group.
The primary outcome is increases in physical activity between baseline and the end of the program as measured by pedometer.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Participants in the physical activity program will participate in 12 weekly 1.5-hour sessions focused on increasing physical activity.
The group sessions will include participating in physical activity as well as group discussions on the barriers and opportunities for increasing physical activity in their daily life.
The 12-week program covers educational topics related to physical activity (e.g.
overcoming barriers to activity, exercising safely, relapse prevention strategies) and the program gradually increases the amount of physical activity completed during the group sessions over the course of the 12 weeks.
Over a 3-month wait period, individuals in the wait-list control group will be offered monthly sessions on health and wellness topics before being offered the physical activity program.
Measurement visits will occur at baseline, at the end of the12-week program, and approximately 12-weeks after the end of the intervention.
During the measurement sessions participants will complete assessments related to their physical activity and other health behaviors.
Studietype
Intervensjonell
Registrering (Faktiske)
27
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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California
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La Jolla, California, Forente stater, 92093-0725
- University of California San Diego
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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
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Sedentary (less than 90 minutes per week of moderate or vigorous physical activity)
- Self-identify as Somali
- Planning on living in the area for the next 6 months
- Ability to attend 12-weeks of in-person group sessions at a designated community site
Exclusion Criteria:
- Currently pregnant or within 3 months of delivery
- BMI greater than or equal to 40
- Medical conditions or physical problems that interfere with physical activity or require medical supervision to exercise
- Have another member of the household participating in the study
- Employment by one of the collaborating organizations
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Physical Activity
Participants in the Physical Activity intervention arm of the study receive culturally-modified, materials through participation in 12 weekly 1-.5-hour sessions focused on increasing daily step counts and bouts of moderate intensity physical activity.
The group sessions include participation in different forms of physical activity as well as group discussions on the barriers and opportunities for increasing physical activity in daily life.
|
The Physical Activity intervention is a 3-month group-based program based on an efficacious physical activity intervention that has been culturally adapted for use with adult Somali women.
The program targets increased physical activity through educational and experiential opportunities.
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|
Ingen inngripen: Wait List Control
Participants in the Wait List Control will be offered the program after a 3-month wait period.
While waiting for the program, participants are offered to attend monthly sessions on various wellness and prevention topics.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in physical activity as measured by pedometer from baseline to 3 months
Tidsramme: Baseline and 3 months
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Baseline and 3 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kate E Murray, PhD, MPH, University of California, San Diego
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 2014
Primær fullføring (Faktiske)
1. desember 2015
Studiet fullført (Faktiske)
1. desember 2015
Datoer for studieregistrering
Først innsendt
29. september 2014
Først innsendt som oppfylte QC-kriteriene
29. september 2014
Først lagt ut (Anslag)
2. oktober 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
13. mai 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mai 2016
Sist bekreftet
1. mai 2016
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- ACS-MRSG-13-069
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. .