NCT00869583

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

August 16, 2019

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

March 25, 2009

Last Update Submit

August 14, 2019

Conditions

ObesityHeart Diseases

Keywords

WomenPhysical ActivityHispanicOverweight

Outcome Measures

Primary Outcomes (1)

  • Moderate to vigorous physical activity (measured by accelerometry and self-report)

    Measured at baseline and Month 6

Secondary Outcomes (1)

  • Body mass index

    Measured at baseline and Month 6

Study Arms (2)

1

EXPERIMENTAL

Participants will immediately take part in the physical activity program.

Behavioral: Physical Activity Program

2

NO INTERVENTION

Interventions

Physical Activity ProgramBEHAVIORAL

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.

1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78230, United States

Location

Related Publications (1)

  • 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.

    PMID: 21731409BACKGROUND

MeSH Terms

Conditions

ObesityHeart DiseasesMotor ActivityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCardiovascular DiseasesBehavior

Study Officials

  • Deborah Parra-Medina, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

August 16, 2019

Record last verified: 2014-01

Locations

US(2)