Increasing Physical Activity Among Mexican American Women (The Enlace Study)
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Heart Diseases |
Behavioral: Physical Activity Program |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Enlace: A Partnership to Promote Physical Activity Among Mexican Immigrant Women |
- Moderate to vigorous physical activity (measured by accelerometry and self-report) [ Time Frame: Measured at baseline and Month 6 ] [ Designated as safety issue: No ]
- Body mass index [ Time Frame: Measured at baseline and Month 6 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
Participants will not take part in the physical activity program during the 6-month study period. They will take part in the program only after their participation in the study has ended.
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Deborah Parra-Medina, PhD | 210-562-6521 | parramedina@uthscsa.edu |
| United States, South Carolina | |
| University of South Carolina | Not yet recruiting |
| Columbia, South Carolina, United States, 29208 | |
| Contact: DeAnne Messias, PhD 803-777-8423 deanne.messias@sc.edu | |
| Contact: Lisa Spruil lspruill@mailbox.sc.edu | |
| Principal Investigator: DeAnne Messias, PhD | |
| Sub-Investigator: Patricia Sharpe, PhD | |
| United States, Texas | |
| University of Texas Health Science Center San Antonio | Not yet recruiting |
| San Antonio, Texas, United States, 78230 | |
| Contact: Deborah Parra-Medina, PhD 210-562-6521 parramedina@uthscsa.edu | |
| Principal Investigator: Deborah Parra-Medina, PhD, MPH | |
| Principal Investigator: | Deborah Parra-Medina, PhD | The University of Texas Health Science Center, Houston |
More Information
No publications provided
| Responsible Party: | Deborah Parra-Medina, PhD, University of Texas Health Sciences Center at San Antonio |
| ClinicalTrials.gov Identifier: | NCT00869583 History of Changes |
| Other Study ID Numbers: | 642, 7R21 HL087765 |
| Study First Received: | March 25, 2009 |
| Last Updated: | July 10, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
|
Women Physical Activity Hispanic Overweight |
Additional relevant MeSH terms:
|
Heart Diseases Obesity Cardiovascular Diseases Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013