NCT05613231

Brief Summary

The disproportionately low physical activity (PA) in Latinas, particularly muscle-strengthening activities, and related chronic diseases (e.g., obesity, diabetes, cancer) signifies an urgent public health concern. To address the lack of interventions promoting muscle-strengthening activities exclusively for Latinas, the investigators are testing the preliminary efficacy of a culturally and linguistically relevant, web-based aerobic plus muscle-strengthening PA intervention in this at-risk population. The web-based intervention provides a more comprehensive and highly disseminable approach for reducing PA-related health disparities in Latinas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

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

First Submitted

Initial submission to the registry

October 28, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

November 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

1.5 years

First QC Date

October 28, 2022

Last Update Submit

August 9, 2024

Conditions

Keywords

physical activitymuscle-strengthening activitystrength trainingLatinaswomeninterventionInternet

Outcome Measures

Primary Outcomes (2)

  • Change in physical activity as reported by the 7-Day Physical Activity Recall (PAR) from baseline to week 12.

    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.

    Baseline and week 12

  • Change in muscle strengthening activities as reported by the Modifiable Physical Activity Questionnaire (MAQ)

    The MAQ will assess frequency, intensity and duration of muscle strengthening activity

    Baseline and week 12

Secondary Outcomes (3)

  • Change in objectively measured physical activity as reported by ActiGraph accelerometer wear.

    Baseline and week 12

  • Change in upper body strength will be assessed by the one-minute repeated push-up test from baseline to week 12.

    Baseline and week 12

  • Change in lower body strength will be assessed by the one-minute repeated squat test from baseline to week 12..

    Baseline and week 12

Study Arms (2)

Aerobic plus Muscle-Strengthening Activity Intervention

EXPERIMENTAL

Participants will receive access to a web-based, individually tailored, theory-driven aerobic moderate-to-vigorous physical activity (MVPA) intervention that was enhanced with content on muscle-strengthening activity.

Behavioral: Aerobic plus muscle-strengthening physical activity intervention

Original Physical Activity Intervention

ACTIVE COMPARATOR

Participants will receive access to a web-based, individually tailored, theory-driven aerobic moderate-to-vigorous physical activity (MVPA) intervention

Behavioral: Original physical activity intervention

Interventions

The intervention is a 12-week Spanish language, Internet-based intervention promoting both aerobic and muscle-strengthening physical activity for Latina women.

Aerobic plus Muscle-Strengthening Activity Intervention

The intervention is a 12-week Spanish language, Internet-based intervention promoting aerobic physical activity for Latina women.

Original Physical Activity Intervention

Eligibility Criteria

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

You may qualify if:

  • Female
  • Sedentary (Less than 60 minutes per week of moderate or vigorous physical activity)
  • Self-identify as Hispanic or Latino (or of a group defined as Hispanic/Latino by the Census Bureau
  • Must be able to read and write Spanish fluently
  • years of age
  • Have regular access to an Internet-connected device through home, work, or their community (e.g., public library, community center, neighbor's house) and video capabilities on cell phone, tablet, computer, for baseline and 12-week assessments.

You may not qualify if:

  • Any orthopedic condition that would limit mobility
  • History of heart disease, stroke or any other health condition that would make physical activity unsafe
  • BMI above 45 kg/m2
  • Current or planned pregnancy in the next 12 weeks
  • Does not have regular access to an Internet-connected device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 28, 2022

First Posted

November 14, 2022

Study Start

November 3, 2022

Primary Completion

April 22, 2024

Study Completion

April 22, 2024

Last Updated

August 12, 2024

Record last verified: 2024-08

Locations