Pasos Hacia La Salud - Physical Activity Intervention for Latinas

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Dr.Bess Marcus, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01834287
First received: April 12, 2013
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

In this study, investigators are specifically targeting Latina women as they are more likely to be inactive and, therefore, are at higher risk for developing chronic conditions such as obesity, diabetes, or cardiovascular disease.

The objective of Pasos Hacia La Salud is to test a Spanish-language Internet-based Physical Activity Intervention, in comparison to a Spanish-language Internet-based Wellness Contact Control condition. Participants are randomly assigned to one of two groups (Exercise and General Wellness).

The investigators hypothesize that at the end of treatment, intervention participants will report significantly more minutes of moderate intensity physical activity per week than the wellness contact control participants.


Condition Intervention
Inactivity
Behavioral: Physical Activity Intervention
Behavioral: Wellness Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Promoting Physical Activity in Latinas Via Interactive Web-Based Technology

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Change in total weekly minutes of physical activity as measured by the 7-Day PAR (Physical Activity Recall), from Baseline to 6-months and 12-months. [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
    The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities such as time spent sleeping and moderate, hard, and very hard intensity activities. The 7-Day PAR is used across many studies assessing physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other objective measures of activity levels.


Enrollment: 207
Study Start Date: December 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical Activity Intervention
Motivationally-tailored, Spanish Language, Internet-based Physical Activity intervention that specifically addresses the Physical Activity barriers and intervention needs/preferences of Latinas.
Behavioral: Physical Activity Intervention
Participants in the Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, Internet-based Physical Activity intervention that specifically addresses the Physical Activity barriers and intervention needs/preferences of Latinas.
Active Comparator: Wellness Control
Internet-based, Spanish language, Wellness Contact control intervention addressing relevant health topics other than Physical Activity.
Behavioral: Wellness Control
Participants will receive a Spanish language, Internet-based Wellness Contact control intervention addressing relevant health topics other than physical activity.

Detailed Description:

In the U.S., Latino women (Latinas) report higher rates of inactivity than their non-Hispanic White and male counterparts and thus are disproportionately burdened by related health conditions (e.g., cancer, hypertension, heart disease, stroke, diabetes). Cultural factors, socioeconomic circumstances, language and educational barriers limit Latinas access to public health interventions that promote physically active lifestyles. To address this public health crisis, effective interventions that leverage state-of-the-art theory and methods are needed to reach this at-risk population. Our research group has over 20 years experience developing and evaluating individually-tailored, computer expert system-driven, physical activity interventions (based on Social Cognitive Theory and the Transtheoretical Model) through various channels and settings. In our recent pilot (R21NR009864), we culturally and linguistically adapted our tailored intervention for sedentary Latinas and conducted a small randomized trial of the modified program (N=93). A total of 81 participants completed the 6-month study (87% retention) and increased their physical activity from a mean of 17 minutes per week (SD=25.76) at baseline to 147 minutes (SD=241.55) at six months whereas contact control participants increased their physical activity from 12 minutes per week (SD=21.99) at baseline to 97 minutes (SD=118.49) at six months. These observed improvements in physical activity in our intervention group, along with high retention rates, participant-reported desire for an Internet-delivered program, and formative work developing our program in an Internet format lend support for testing an Internet intervention tailored to the needs of Latinas. Therefore, for the current proposal, we will build on our previous work by conducting an adequately powered (N=200) randomized controlled trial to test the efficacy of our culturally and linguistically modified, individually tailored physical activity intervention delivered via the Internet relative to an Internet wellness contact control condition (including cardiovascular health information developed for Latinos by the NHLBI). Data will be collected at baseline, 6 months (post-treatment), and 12 months (maintenance) using well-established physical activity measures (7-Day PAR, Actigraphs), as well as a comprehensive set of psychosocial questionnaires. We hypothesize that at end of treatment (month six) intervention participants will report significantly more minutes of moderate intensity physical activity per week than the wellness contact control participants. We will also examine the maintenance of treatment effects at 12 months, potential mediators and moderators of the intervention-physical activity relationship, and the costs of delivering the tailored Internet program. In the proposed study we seek to promote physical activity among an underserved population using a high-reach, low-cost, technology-based strategy, which has great potential for adoption on a larger scale and thus high potential for reducing health disparities in the U.S.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Generally healthy (If asthma and/or high blood pressure, may be able to participate with physician consent)
  • Sedentary (Less than 60 minutes per week of moderate or vigorous physical activity)
  • Latina (self-identified)
  • Must be able to read and write Spanish fluently
  • 18 - 65 years of age
  • Planning on living in the area for the next 12 months
  • Daily access to a computer with high speed internet

Exclusion Criteria:

  • Pregnant or planning on becoming pregnant
  • BMI greater than 45
  • Not able to walk continuously for 30 minutes/limited ability to complete daily activity or ability to exercise
  • Exercise is against advice of doctor
  • Heart disease/treatment
  • Heart murmur
  • Angina/chest pain or Angina/chest pain with exertion
  • Palpitations
  • Stroke/Transient Ischemic Attacks
  • Peripheral Vascular Disease
  • Diabetes I or II
  • Chronic Infectious Disease - HIV, Hepatitis
  • Chronic liver disease
  • Cystic Fibrosis
  • Abnormal EKG on last EKG performed
  • Emphysema, Chronic bronchitis, Chronic Obstructive Pulmonary Disease
  • Seizure in past year
  • Surgery in past year on heart, lung, joint, orthopedic surgery
  • Surgery pending in next year on lung, joint, orthopedic surgery
  • Unusual/concerning shortness of breath
  • Asthma (may be able to participate with physician consent)
  • High blood pressure/high blood pressure medication (may be able to participate with physician consent)
  • Use of beta blockers
  • Abnormal Medical Stress Test
  • Musculoskeletal problems
  • Fainting/dizziness more than 3 times in past year OR interferes with daily activities OR causes loss of balance
  • Cancer treatment in past 3 months
  • Hospitalized for psychiatric disorder in past 3 years or suicidal
  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: NCT01834287

Locations
United States, California
University of California San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Bess H Marcus, PhD University of California, San Diego
  More Information

No publications provided

Responsible Party: Dr.Bess Marcus, Professor and Chair, Department of Family and Preventive Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01834287     History of Changes
Other Study ID Numbers: Pasos Hacia La Salud, R01CA159954-02
Study First Received: April 12, 2013
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Physical Activity
Latinas
Web-based
Spanish-language

ClinicalTrials.gov processed this record on August 21, 2014