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Promoting Physical Activity in Latinas Via Interactive Web-Based Technology


N/A
18 Years
65 Years
Open (Enrolling)
Female
Inactivity

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Trial Information

Promoting Physical Activity in Latinas Via Interactive Web-Based Technology


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Description:

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.

Outcome Time Frame:

Baseline, 6 months, and 12 months

Safety Issue:

No

Principal Investigator

Bess H Marcus, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Diego

Authority:

United States: Institutional Review Board

Study ID:

Pasos Hacia La Salud

NCT ID:

NCT01834287

Start Date:

December 2011

Completion Date:

September 2014

Related Keywords:

  • Inactivity
  • Physical Activity
  • Latinas
  • Web-based
  • Spanish-language

Name

Location

University of California San Diego La Jolla, California  92093