Clinical trial NCT00869583: Increasing Physical Activity Among Mexican American Women (The Enlace Study)
Official title: Enlace: A Partnership to Promote Physical Activity Among Mexican Immigrant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Heart Diseases
Keywords: Women
Physical Activity
Hispanic
Overweight
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-03-26
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: Moderate to vigorous physical activity (measured by accelerometry and self-report)
timeFrame: Measured at baseline and Month 6
Secondary outcomes:
measure: Body mass index
timeFrame: Measured at baseline and Month 6
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
city: San Antonio
country: United States
facility: University of Texas Health Science Center San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Deborah Parra-Medina, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parra-Medina D, Hilfinger Messias DK. Promotion of Physical Activity Among Mexican-Origin Women in Texas and South Carolina: An Examination of Social, Cultural, Economic, and Environmental Factors. Quest. 2011 Feb;63(1):100-117. doi: 10.1080/00336297.2011.10483668.