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Promoting Physical Activity in Churchgoing Latinas

27. september 2021 opdateret af: Elva Arredondo, San Diego State University

Promoting Physical Activity in Churchgoing Latinas: Fe en Acción (Faith in Action)

The low prevalence of moderate-to-vigorous physical activity (MVPA) among adult Latinas likely contributes to the high rates of cancer and other chronic diseases in this population. The goals of the current study, based largely upon the core principles of the Social Ecological Model, are to design, implement, and evaluate an innovative multi-level intervention promoting physical activity among churchgoing Latinas.

The evidenced-based intervention targets three "tiers" of environmental influences (i.e., church, immediate neighborhood surrounding the church, and community) on activity, as well as MVPA-related personal factors (i.e.., interpersonal, cultural, and perceived environmental variables). The physical activity intervention will be compared with an attention-control condition providing health education on cancer screening and prevention.

Sixteen churches will be randomly assigned to either the physical activity intervention or the attention-control condition. The primary aim of the study is to determine whether a multi-level intervention will increase MVPA among Latina churchgoers in the intervention condition relative to the attention-control condition.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This two-group randomized controlled trial combines innovative and traditional methods for promoting moderate-to-vigorous physical activity (MVPA) and cancer screening (breast, cervical, colorectal, and skin) among Latinas, and is tested simultaneously in a two-group design. Both interventions lasted two years. The study's primary outcome was min/week of accelerometer-assessed MVPA at baseline (M1) and 12 months (M2) and 24 months (M3) following the start of the intervention.We selected cancer screening as a comparison condition given the relevance of this topic to our target community (i.e., low cervical and colorectal cancer screening rates and follow-up). It was hypothesized that over time, participants in the physical activity condition would engage in significantly higher levels of MVPA, compared to participants in the cancer screening condition. We also expected greater changes in individual-, interpersonal-, and environmental-level correlates of physical activity among participants in the physical activity condition compared to those in the cancer screening condition. Conversely, we expected that participants in the cancer screening condition would engage in higher screening rates compared to those in the physical activity intervention.We anticipated greater changes in individual, interpersonal, and environmental correlates of cancer screening in this condition compared to the physical activity condition.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

436

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
      • San Diego, California, Forenede Stater, 92123
        • San Diego State University Research Foundation

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Between the ages of 18-65 years of age
  • Latino
  • Must be a member of a participating church for at least six months
  • Live within 10-15 minutes driving distance from the church
  • Able to travel to the church during the week
  • Able to attend activities at the church during the week
  • Attend church activities (worship or otherwise) at least 4 times a month
  • Plan on living in same residence for the next 24 months
  • Engage in less than 150 minutes of moderate-to-vigorous physical activity per week

Exclusion Criteria:

  • Attendance at other churches participating in the study
  • Must not have any conditions limiting ability to be physically active
  • Pregnant

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: Physical activity
Latinas exposed to multi-level Faith in Action intervention promoting physical activity.
Adfærdsmæssigt: Physical activity
Promotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors.
Andre navne:
  • Faith in Action
  • Fe en Acción
Aktiv komparator: Cancer screening
Latinas exposed to Faith in Action intervention on cancer screening and prevention.
Adfærdsmæssigt: Cancer screening
Promotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA)
Tidsramme: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Change from baseline in moderate-to-vigorous physical activity as assessed by accelerometer
assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Self-report Leisure-time MVPA
Tidsramme: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Change from baseline in self-reported leisure-time moderate-to-vigorous physical activity
assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body Mass Index (BMI)
Tidsramme: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Change from baseline in body mass index (BMI)
assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Waist Circumference
Tidsramme: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Change from baseline in waist circumference
assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported

Samarbejdspartnere og efterforskere

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

Sponsor

San Diego State University

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Elva M Arredondo, PhD, San Diego State University

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 (Faktiske)

11. maj 2011

Primær færdiggørelse (Faktiske)

21. december 2015

Studieafslutning (Faktiske)

21. december 2015

Datoer for studieregistrering

Først indsendt

29. oktober 2012

Først indsendt, der opfyldte QC-kriterier

23. januar 2013

Først opslået (Skøn)

28. januar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R01CA138894 (U.S. NIH-bevilling/kontrakt)
  • R01CA138894-05S1 (U.S. NIH-bevilling/kontrakt)
  • R01CA138894-05S2 (U.S. NIH-bevilling/kontrakt)

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 .

Kliniske forsøg med Kronisk sygdom

Kliniske forsøg med Physical activity

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CROs in Latvia

Betingelser

Sjældne sygdomme

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Sponsor / samarbejdspartnere

Placeringer

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