- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01776632
Promoting Physical Activity in Churchgoing Latinas
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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California
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San Diego, California, Spojené státy, 92123
- San Diego State University Research Foundation
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Physical activity
Latinas exposed to multi-level Faith in Action intervention promoting physical activity.
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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.
Ostatní jména:
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Aktivní komparátor: Cancer screening
Latinas exposed to Faith in Action intervention on cancer screening and prevention.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA)
Časové okno: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
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Change from baseline in moderate-to-vigorous physical activity as assessed by accelerometer
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assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
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Self-report Leisure-time MVPA
Časové okno: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
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Change from baseline in self-reported leisure-time moderate-to-vigorous physical activity
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assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Body Mass Index (BMI)
Časové okno: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
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Change from baseline in body mass index (BMI)
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assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
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Waist Circumference
Časové okno: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
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Change from baseline in waist circumference
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assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Elva M Arredondo, PhD, San Diego State University
Publikace a užitečné odkazy
Obecné publikace
- Arredondo EM, Haughton J, Ayala GX, Slymen DJ, Sallis JF, Burke K, Holub C, Chanson D, Perez LG, Valdivia R, Ryan S, Elder J. Fe en Accion/Faith in Action: Design and implementation of a church-based randomized trial to promote physical activity and cancer screening among churchgoing Latinas. Contemp Clin Trials. 2015 Nov;45(Pt B):404-415. doi: 10.1016/j.cct.2015.09.008. Epub 2015 Sep 8.
- Haughton J, Ayala GX, Burke KH, Elder JP, Montanez J, Arredondo EM. Community Health Workers Promoting Physical Activity: Targeting Multiple Levels of the Social Ecological Model. J Ambul Care Manage. 2015 Oct-Dec;38(4):309-20. doi: 10.1097/JAC.0000000000000108.
- Beard M, Chuang E, Haughton J, Arredondo EM. Determinants of Implementation Effectiveness in a Physical Activity Program for Church-Going Latinas. Fam Community Health. 2016 Oct-Dec;39(4):225-33. doi: 10.1097/FCH.0000000000000122.
- Perez LG, Slymen DJ, Sallis JF, Ayala GX, Elder JP, Arredondo EM. Interactions between individual and perceived environmental factors on Latinas' physical activity. J Public Health (Oxf). 2017 Jun 1;39(2):e10-e18. doi: 10.1093/pubmed/fdw061.
- Perez LG, Chavez A, Marquez DX, Soto SC, Haughton J, Arredondo EM. Associations of Acculturation With Self-Report and Objective Physical Activity and Sedentary Behaviors Among Latinas. Health Educ Behav. 2017 Jun;44(3):431-438. doi: 10.1177/1090198116669802. Epub 2016 Sep 27.
- Perez LG, Carlson J, Slymen DJ, Patrick K, Kerr J, Godbole S, Elder JP, Ayala GX, Arredondo EM. Does the social environment moderate associations of the built environment with Latinas' objectively-measured neighborhood outdoor physical activity? Prev Med Rep. 2016 Oct 19;4:551-557. doi: 10.1016/j.pmedr.2016.10.006. eCollection 2016 Dec.
- Tristao Parra M, Porfirio GJM, Arredondo EM, Atallah AN. Physical Activity Interventions in Faith-Based Organizations: A Systematic Review. Am J Health Promot. 2018 Mar;32(3):677-690. doi: 10.1177/0890117116688107. Epub 2017 Jan 13.
- Elder JP, Haughton J, Perez LG, Martinez ME, De la Torre CL, Slymen DJ, Arredondo EM. Promoting cancer screening among churchgoing Latinas: Fe en Accion/faith in action. Health Educ Res. 2017 Apr 1;32(2):163-173. doi: 10.1093/her/cyx033.
- Soto SH, Arredondo EM, Haughton J, Shakya H. Leisure-Time Physical Activity and Characteristics of Social Network Support for Exercise Among Latinas. Am J Health Promot. 2018 Feb;32(2):432-439. doi: 10.1177/0890117117699927. Epub 2017 Mar 31.
- Perez LG, Elder JP, Haughton J, Martinez ME, Arredondo EM. Socio-demographic Moderators of Associations Between Psychological Factors and Latinas' Breast Cancer Screening Behaviors. J Immigr Minor Health. 2018 Aug;20(4):823-830. doi: 10.1007/s10903-017-0633-1. Erratum In: J Immigr Minor Health. 2017 Aug 9;:
- Perez LG, Kerr J, Sallis JF, Slymen D, McKenzie TL, Elder JP, Arredondo EM. Perceived Neighborhood Environmental Factors That Maximize the Effectiveness of a Multilevel Intervention Promoting Physical Activity Among Latinas. Am J Health Promot. 2018 Feb;32(2):334-343. doi: 10.1177/0890117117742999. Epub 2017 Nov 22.
- Arredondo EM, Elder JP, Haughton J, Slymen DJ, Sallis JF, Perez LG, Serrano N, Parra MT, Valdivia R, Ayala GX. Fe en Accion: Promoting Physical Activity Among Churchgoing Latinas. Am J Public Health. 2017 Jul;107(7):1109-1115. doi: 10.2105/AJPH.2017.303785. Epub 2017 May 18.
- Arredondo EM, Haughton J, Ayala GX, Slymen D, Sallis JF, Perez LG, Serrano N, Ryan S, Valdivia R, Lopez NV, Elder JP. Two-year outcomes of Faith in Action/Fe en Accion: a randomized controlled trial of physical activity promotion in Latinas. Int J Behav Nutr Phys Act. 2022 Jul 30;19(1):97. doi: 10.1186/s12966-022-01329-6.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R01CA138894 (Grant/smlouva NIH USA)
- R01CA138894-05S1 (Grant/smlouva NIH USA)
- R01CA138894-05S2 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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