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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Deborah Parra-Medina, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00869583
First received: March 25, 2009
Last updated: January 6, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Moderate to vigorous physical activity (measured by accelerometry and self-report) [ Time Frame: Measured at baseline and Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body mass index [ Time Frame: Measured at baseline and Month 6 ] [ Designated as safety issue: No ]

Enrollment: 117
Study Start Date: August 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (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

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869583

Locations
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
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Deborah Parra-Medina, PhD The University of Texas Health Science Center, Houston
  More Information

Publications:
Responsible Party: Deborah Parra-Medina, Professor, Epidemiology and Biostatistics, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00869583     History of Changes
Other Study ID Numbers: 642, R21HL087765, 7R21 HL087765
Study First Received: March 25, 2009
Last Updated: January 6, 2014
Health Authority: United States: Federal Government

Keywords provided by The University of Texas Health Science Center at San Antonio:
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 July 31, 2014