- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01583140
Seamos Saludables - Physical Activity Intervention Study for Latinas
Culturally and Linguistically Adapted Physical Activity Intervention for Latinas (Seamos Saludables)
In this study the investigators are specifically targeting Latina women because they are more likely to be inactive and, therefore, are at higher risk for developing chronic conditions like obesity, diabetes, or cardiovascular disease. Through focus groups and cognitive interviews with Latinas in the Providence area, the investigators have modified our print-based intervention, already tested and proven to be effective in English-speaking communities, to be culturally and linguistically appropriate for the Latina community.
The objective of Seamos Saludables is to determine whether this culturally tailored print intervention will produce greater increases in physical activity levels among Latina women than a program focused on general health topics. Participants are randomly assigned to one of two groups (exercise and general wellness) and attend 4 clinic visits to complete baseline and follow-up assessments.
The investigators hypothesize that at the end of treatment, intervention participants will report significantly more minutes of at least moderate intensity physical activity per week than the wellness contact control participants.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Rhode Island
-
Providence, Rhode Island, Förenta staterna, 02903
- Brown University Institute for Community Health Promotion
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Females
- Generally healthy
- Sedentary (Less than 60 minutes per week of mod or vigorous physical activity)
- Latina (self-defined)
- 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
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/TIA
- 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, COPD
- 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
- High blood pressure/high blood pressure medication
- 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
- 3 or more alcoholic beverages 5 or more days per week
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Exercise Intervention
Culturally-modified, individually tailored physical activity print materials
|
Participants in the Physical Activity Intervention arm of the study receive culturally-modified, individually tailored physical activity print materials.
|
Aktiv komparator: Control
Bilingual health education booklets
|
Participants in the Wellness Control arm of the study receive a variety of print materials focused on general health topics.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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
Tidsram: 6 and 12 months
|
The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities including time spent sleeping and in moderate, hard, and very hard activity.
The 7-Day PAR is used across many studies in physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other more objective measures of activity levels, along with sensitivity to changes in both moderate and intensive levels of physical activity.
|
6 and 12 months
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Bess H Marcus, Ph.D., University of California, San Diego
Publikationer och användbara länkar
Allmänna publikationer
- Pekmezi DW, Neighbors CJ, Lee CS, Gans KM, Bock BC, Morrow KM, Marquez B, Dunsiger S, Marcus BH. A culturally adapted physical activity intervention for Latinas: a randomized controlled trial. Am J Prev Med. 2009 Dec;37(6):495-500. doi: 10.1016/j.amepre.2009.08.023.
- Benitez TJ, Dunsiger S, Marquez B, Larsen B, Pekmezi D, Marcus BH. Increases in Muscle-Strengthening Activities Among Latinas in Seamos Saludables. Health Educ Behav. 2022 Jun;49(3):446-454. doi: 10.1177/10901981221074908. Epub 2022 Feb 28.
- Larsen B, Gilmer T, Pekmezi D, Napolitano MA, Marcus BH. Cost effectiveness of a mail-delivered individually tailored physical activity intervention for Latinas vs. a mailed contact control. Int J Behav Nutr Phys Act. 2015 Nov 11;12:140. doi: 10.1186/s12966-015-0302-5.
- Marcus BH, Dunsiger SI, Pekmezi D, Larsen BA, Marquez B, Bock BC, Gans KM, Morrow KM, Tilkemeier P. Twelve-month physical activity outcomes in Latinas in the Seamos Saludables trial. Am J Prev Med. 2015 Feb;48(2):179-182. doi: 10.1016/j.amepre.2014.08.032. Epub 2014 Nov 6.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- SALUDABLES-2009
- 5R01NR011295 (U.S.S. NIH-anslag/kontrakt)
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