NCT01834287

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
10.7 years until next milestone

Results Posted

Study results publicly available

November 25, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

3.2 years

First QC Date

April 12, 2013

Results QC Date

November 11, 2025

Last Update Submit

November 20, 2025

Conditions

Keywords

Physical ActivityLatinasWeb-basedSpanish-language

Outcome Measures

Primary Outcomes (1)

  • Total Weekly Minutes of Physical Activity as Measured by the 7-Day PAR (Physical Activity Recall), From Baseline to 6-months and 12-months.

    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.

    Baseline, 6 months, and 12 months

Study Arms (2)

Physical Activity Intervention

EXPERIMENTAL

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

Wellness Control

ACTIVE COMPARATOR

Internet-based, Spanish language, Wellness Contact control intervention addressing relevant health topics other than Physical Activity.

Behavioral: Wellness Control

Interventions

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.

Physical Activity Intervention

Participants will receive a Spanish language, Internet-based Wellness Contact control intervention addressing relevant health topics other than physical activity.

Wellness Control

Eligibility Criteria

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

You may qualify if:

  • 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
  • years of age
  • Planning on living in the area for the next 12 months
  • Daily access to a computer with high speed internet

You may not qualify if:

  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

Location

Related Publications (6)

  • Larsen B, Dunsiger SI, Pekmezi D, Linke S, Hartman SJ, Marcus BH. Psychosocial mediators of physical activity change in a web-based intervention for Latinas. Health Psychol. 2021 Jan;40(1):21-29. doi: 10.1037/hea0001041. Epub 2020 Nov 23.

  • Hartman SJ, Pekmezi D, Dunsiger SI, Marcus BH. Physical Activity Intervention Effects on Sedentary Time in Spanish-Speaking Latinas. J Phys Act Health. 2020 Mar 1;17(3):343-348. doi: 10.1123/jpah.2019-0112.

  • Linke SE, Dunsiger SI, Gans KM, Hartman SJ, Pekmezi D, Larsen BA, Mendoza-Vasconez AS, Marcus BH. Association Between Physical Activity Intervention Website Use and Physical Activity Levels Among Spanish-Speaking Latinas: Randomized Controlled Trial. J Med Internet Res. 2019 Jul 24;21(7):e13063. doi: 10.2196/13063.

  • Marquez B, Norman GJ, Fowler JH, Gans KM, Marcus BH. Weight and weight control behaviors of Latinas and their social ties. Health Psychol. 2018 Apr;37(4):318-325. doi: 10.1037/hea0000597. Epub 2018 Feb 1.

  • Larsen B, Marcus B, Pekmezi D, Hartman S, Gilmer T. A Web-Based Physical Activity Intervention for Spanish-Speaking Latinas: A Costs and Cost-Effectiveness Analysis. J Med Internet Res. 2017 Feb 22;19(2):e43. doi: 10.2196/jmir.6257.

  • Marcus BH, Hartman SJ, Larsen BA, Pekmezi D, Dunsiger SI, Linke S, Marquez B, Gans KM, Bock BC, Mendoza-Vasconez AS, Noble ML, Rojas C. Pasos Hacia La Salud: a randomized controlled trial of an internet-delivered physical activity intervention for Latinas. Int J Behav Nutr Phys Act. 2016 May 28;13:62. doi: 10.1186/s12966-016-0385-7.

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Bess Marcus
Organization
Brown University

Study Officials

  • Bess H Marcus, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair, Department of Family and Preventive Medicine

Study Record Dates

First Submitted

April 12, 2013

First Posted

April 17, 2013

Study Start

December 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

November 25, 2025

Results First Posted

November 25, 2025

Record last verified: 2025-11

Locations