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Increasing Physical Activity Among Mexican American Women (The Enlace Study)

Enlace: A Partnership to Promote Physical Activity Among Mexican Immigrant Women

Obesity is a serious health problem among Mexican American women. Obesity combined with a lack of physical activity can increase the risk for several diseases, including heart disease. This study will evaluate a program that aims to increase physical activity levels among women of Mexican origin in Columbia, South Carolina and the Lower Rio Grande Valley of Texas.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Mexican American women in the United States are more likely to live a sedentary lifestyle than women of other ethnic groups. As a result, obesity affects Mexican American women at a high rate. Obesity and a lack of physical activity are risk factors for many diseases, including heart disease, diabetes, and certain types of cancers. Increasing physical activity can lead to weight loss and lower the risk of developing these diseases. This study represents a partnership between the University of South Carolina, the South Carolina Hispanic Latino Health Coalition, and the University of Texas Health Sciences Center at San Antonio (UTHSCSA) Regional Academic Health Center in the Lower Rio Grande Valley of Texas. Study researchers from these institutions will first conduct interviews and focus groups and then develop a program aimed at encouraging moderately intense physical activity among Mexican American women. Next, the study will evaluate the effectiveness of that program at increasing physical activity levels and promoting weight loss among Mexican American women in Columbia, South Carolina and the Lower Rio Grande Valley of Texas.

This study will enroll Mexican American women. Participants will be randomly assigned to either immediately take part in the physical activity program or take part in the program at the end of the 6-month study. At baseline, all participants will receive home visits from study staff. During these visits, participants will undergo weight, height, and waist measurements. Participants will also complete questionnaires to assess their medical history and physical activity habits. For 1 week after the study visit, participants will wear a physical activity monitor and keep an activity diary. Participants who are assigned to immediately take part in the physical activity program will receive counseling from a community health educator that will focus on the importance of changing physical activity habits. They will be encouraged to partake in 30 minutes of daily physical activity for at least 5 days a week. Each month, participants will receive educational materials and telephone calls or visits from the health educator. Participants will receive a pedometer and will be asked to keep a daily log of their physical activity. At Month 6, all participants will receive another home study visit for repeat baseline testing. At this time, participants who did not take part initially in the physical activity program will start the program. However, they will have no further study visits or evaluations.

Studietyp

Interventionell

Inskrivning (Faktisk)

117

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • South Carolina
      • Columbia, South Carolina, Förenta staterna, 29208
        • University of South Carolina
    • Texas
      • San Antonio, Texas, Förenta staterna, 78230
        • University of Texas Health Science Center San Antonio

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

  • Self-identifies as being of Mexican origin
  • Has a personal telephone
  • Resides in the study area and intends to stay in the area for the entire study period
  • Able to understand Spanish
  • Does not currently meet physical activity level recommendations
  • Interested in receiving information on physical activity
  • Willing to be assigned to either study group
  • Willing to attend the program sessions and complete standardized measurements

Exclusion Criteria:

  • Not physically able to participate in a moderate intensity walking program and not able to understand and verbally respond to questions
  • Pregnant
  • Diabetes
  • Uncontrolled hypertension
  • Undergoing therapy for life-threatening illnesses (e.g., chemotherapy or radiation therapy)
  • Positive (risk) responses on the Physical Activity Readiness Questionnaire (PAR-Q) and subsequent physician disapproval on the Physical Activity Readiness Medical Examination (PAR-Med-X)
  • Already gets 5 or more days per week of 30 minutes of moderately intense activity, based on the responses to the six questions concerning frequency and duration of moderately and vigorously intense physical activity from the Behavioral Risk Factor Surveillance Survey

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: 2
Experimentell: 1
Participants will immediately take part in the physical activity program.
Participants will receive counseling from a community health educator that will focus on the importance of increasing physical activity. Participants will be encouraged to engage in moderate physical activity (3.0 to 6.0 metabolic equivalents [METS]) for 30 minutes on 5 or more days per week. Participants will be encouraged to start their physical activity program slowly and to gradually increase both frequency and intensity to meet the study goal (e.g., beginning with three sessions per week for 15 minutes and building up to five sessions per week for 30 minutes by Week 12). They will receive educational materials and telephone calls or visits from health educators on a monthly basis for 6 months.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Moderate to vigorous physical activity (measured by accelerometry and self-report)
Tidsram: Measured at baseline and Month 6
Measured at baseline and Month 6

Sekundära resultatmått

Resultatmått
Tidsram
Body mass index
Tidsram: Measured at baseline and Month 6
Measured at baseline and Month 6

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Deborah Parra-Medina, PhD, The University of Texas Health Science Center, Houston

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2009

Primärt slutförande (Faktisk)

1 oktober 2010

Avslutad studie (Faktisk)

1 oktober 2010

Studieregistreringsdatum

Först inskickad

25 mars 2009

Först inskickad som uppfyllde QC-kriterierna

25 mars 2009

Första postat (Uppskatta)

26 mars 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 augusti 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 augusti 2019

Senast verifierad

1 januari 2014

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 642
  • R21HL087765 (U.S.S. NIH-anslag/kontrakt)
  • 7R21HL087765 (U.S.S. NIH-anslag/kontrakt)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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