- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01834287
Pasos Hacia La Salud - Physical Activity Intervention for Latinas
Promoting Physical Activity in Latinas Via Interactive Web-Based Technology
In this study, investigators are specifically targeting Latina women as they are more likely to be inactive and, therefore, are at higher risk for developing chronic conditions such as obesity, diabetes, or cardiovascular disease.
The objective of Pasos Hacia La Salud is to test a Spanish-language Internet-based Physical Activity Intervention, in comparison to a Spanish-language Internet-based Wellness Contact Control condition. Participants are randomly assigned to one of two groups (Exercise and General Wellness).
The investigators hypothesize that at the end of treatment, intervention participants will report significantly more minutes of moderate intensity physical activity per week than the wellness contact control participants.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
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La Jolla, California, Forenede Stater, 92093
- University of California San Diego
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Female
- Generally healthy (If asthma and/or high blood pressure, may be able to participate with physician consent)
- Sedentary (Less than 60 minutes per week of moderate or vigorous physical activity)
- Latina (self-identified)
- Must be able to read and write Spanish fluently
- 18 - 65 years of age
- Planning on living in the area for the next 12 months
- Daily access to a computer with high speed internet
Exclusion Criteria:
- Pregnant or planning on becoming pregnant
- BMI greater than 45
- Not able to walk continuously for 30 minutes/limited ability to complete daily activity or ability to exercise
- Exercise is against advice of doctor
- Heart disease/treatment
- Heart murmur
- Angina/chest pain or Angina/chest pain with exertion
- Palpitations
- Stroke/Transient Ischemic Attacks
- Peripheral Vascular Disease
- Diabetes I or II
- Chronic Infectious Disease - HIV, Hepatitis
- Chronic liver disease
- Cystic Fibrosis
- Abnormal EKG on last EKG performed
- Emphysema, Chronic bronchitis, Chronic Obstructive Pulmonary Disease
- Seizure in past year
- Surgery in past year on heart, lung, joint, orthopedic surgery
- Surgery pending in next year on lung, joint, orthopedic surgery
- Unusual/concerning shortness of breath
- Asthma (may be able to participate with physician consent)
- High blood pressure/high blood pressure medication (may be able to participate with physician consent)
- Use of beta blockers
- Abnormal Medical Stress Test
- Musculoskeletal problems
- Fainting/dizziness more than 3 times in past year OR interferes with daily activities OR causes loss of balance
- Cancer treatment in past 3 months
- Hospitalized for psychiatric disorder in past 3 years or suicidal
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Physical Activity Intervention
Motivationally-tailored, Spanish Language, Internet-based Physical Activity intervention that specifically addresses the Physical Activity barriers and intervention needs/preferences of Latinas.
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Participants in the Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, Internet-based Physical Activity intervention that specifically addresses the Physical Activity barriers and intervention needs/preferences of Latinas.
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Aktiv komparator: Wellness Control
Internet-based, Spanish language, Wellness Contact control intervention addressing relevant health topics other than Physical Activity.
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Participants will receive a Spanish language, Internet-based Wellness Contact control intervention addressing relevant health topics other than physical activity.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in total weekly minutes of physical activity as measured by the 7-Day PAR (Physical Activity Recall), from Baseline to 6-months and 12-months.
Tidsramme: Baseline, 6 months, and 12 months
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The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities such as time spent sleeping and moderate, hard, and very hard intensity activities.
The 7-Day PAR is used across many studies assessing physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other objective measures of activity levels.
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Baseline, 6 months, and 12 months
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- Larsen B, Dunsiger SI, Pekmezi D, Linke S, Hartman SJ, Marcus BH. Psychosocial mediators of physical activity change in a web-based intervention for Latinas. Health Psychol. 2021 Jan;40(1):21-29. doi: 10.1037/hea0001041. Epub 2020 Nov 23.
- Hartman SJ, Pekmezi D, Dunsiger SI, Marcus BH. Physical Activity Intervention Effects on Sedentary Time in Spanish-Speaking Latinas. J Phys Act Health. 2020 Mar 1;17(3):343-348. doi: 10.1123/jpah.2019-0112.
- Linke SE, Dunsiger SI, Gans KM, Hartman SJ, Pekmezi D, Larsen BA, Mendoza-Vasconez AS, Marcus BH. Association Between Physical Activity Intervention Website Use and Physical Activity Levels Among Spanish-Speaking Latinas: Randomized Controlled Trial. J Med Internet Res. 2019 Jul 24;21(7):e13063. doi: 10.2196/13063.
- Marquez B, Norman GJ, Fowler JH, Gans KM, Marcus BH. Weight and weight control behaviors of Latinas and their social ties. Health Psychol. 2018 Apr;37(4):318-325. doi: 10.1037/hea0000597. Epub 2018 Feb 1.
- Larsen B, Marcus B, Pekmezi D, Hartman S, Gilmer T. A Web-Based Physical Activity Intervention for Spanish-Speaking Latinas: A Costs and Cost-Effectiveness Analysis. J Med Internet Res. 2017 Feb 22;19(2):e43. doi: 10.2196/jmir.6257.
- Marcus BH, Hartman SJ, Larsen BA, Pekmezi D, Dunsiger SI, Linke S, Marquez B, Gans KM, Bock BC, Mendoza-Vasconez AS, Noble ML, Rojas C. Pasos Hacia La Salud: a randomized controlled trial of an internet-delivered physical activity intervention for Latinas. Int J Behav Nutr Phys Act. 2016 May 28;13:62. doi: 10.1186/s12966-016-0385-7.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Pasos Hacia La Salud
- R01CA159954-02 (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 Physical Activity Intervention
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The Miriam HospitalUkendtSlag | Stillesiddende livsstil | Iskæmisk angreb, forbigående | Dyrke motionForenede Stater
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Wake Forest University Health SciencesNational Heart, Lung, and Blood Institute (NHLBI)AfsluttetFysisk aktivitetForenede Stater
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Centre Hospitalier Universitaire de Saint EtienneNational Cancer Institute, FranceAfsluttetKræft prostataFrankrig
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Cairo UniversityTilmelding efter invitation
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IVI BilbaoInstituto Valenciano de Infertilidad, IVI VALENCIAAfsluttet
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Istanbul Kültür UniversityMarmara University; Istanbul University - Cerrahpasa (IUC)AfsluttetFysisk aktivitet | Parkinsons sygdom | Balance | Falder | KinesiofobiKalkun
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Istanbul Kültür UniversityTrukket tilbageFysisk aktivitetsniveau | Bevidsthed om fysisk aktivitet
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University of Massachusetts, WorcesterEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbejdspartnereAfsluttet
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Istituto Auxologico ItalianoRekrutteringSundhedsadfærdItalien