- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00869583
Increasing Physical Activity Among Mexican American Women (The Enlace Study)
Enlace: A Partnership to Promote Physical Activity Among Mexican Immigrant Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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South Carolina
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Columbia, South Carolina, United States, 29208
- University of South Carolina
-
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Texas
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San Antonio, Texas, United States, 78230
- University of Texas Health Science Center San Antonio
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 2
|
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Experimental: 1
Participants will immediately take part in the physical activity program.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Moderate to vigorous physical activity (measured by accelerometry and self-report)
Time Frame: Measured at baseline and Month 6
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Measured at baseline and Month 6
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body mass index
Time Frame: Measured at baseline and Month 6
|
Measured at baseline and Month 6
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Deborah Parra-Medina, PhD, The University of Texas Health Science Center, Houston
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 642
- R21HL087765 (U.S. NIH Grant/Contract)
- 7R21HL087765 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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