Increasing Physical Activity Among Mexican American Women (The Enlace Study)
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|ClinicalTrials.gov Identifier: NCT00869583|
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : January 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Obesity Heart Diseases||Behavioral: Physical Activity Program||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||117 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Enlace: A Partnership to Promote Physical Activity Among Mexican Immigrant Women|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Participants will immediately take part in the physical activity program.
Behavioral: 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.
|No Intervention: 2|
- Moderate to vigorous physical activity (measured by accelerometry and self-report) [ Time Frame: Measured at baseline and Month 6 ]
- Body mass index [ Time Frame: Measured at baseline and Month 6 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869583
|United States, South Carolina|
|University of South Carolina|
|Columbia, South Carolina, United States, 29208|
|United States, Texas|
|University of Texas Health Science Center San Antonio|
|San Antonio, Texas, United States, 78230|
|Principal Investigator:||Deborah Parra-Medina, PhD||The University of Texas Health Science Center, Houston|