NCT03854916

Brief Summary

Despite numerous interventions designed to increase physical activity, few are specifically tailored to Latinas, a population where higher rates of obesity, diabetes, and other chronic diseases are present. This proposed smartphone app, ¡Caminemos Juntas!, will use location-based services to connect Latinas with one another in order to improve walking habits by increasing social support and decreasing perceived barriers, both of which are known to play a role in physical activity behaviors. Through a randomized comparative-effectiveness trial, this Phase II project will test the effectiveness of a smartphone application for improving physical activity among Latinas when providing them with real-time opportunities to connect socially with the goal of walking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

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

December 11, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

February 28, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 14, 2023

Completed
Last Updated

July 14, 2023

Status Verified

June 1, 2023

Enrollment Period

3.2 years

First QC Date

December 11, 2018

Results QC Date

February 21, 2023

Last Update Submit

June 22, 2023

Conditions

Keywords

Physical ActivityLatinaHispanicWomenMinority HealthMobile TechnologySocial SupportmHealthLocation-based ServicesWalking

Outcome Measures

Primary Outcomes (2)

  • Change in Physical Activity at 4 Weeks

    The Community Healthy Activities Model Program for Seniors (CHAMPS) is a 41-item PA questionnaire that measures self-reported minutes-per-week of PA calculated as total weekly caloric expenditure for all PA. It was developed for underactive populations and validated among older adults. However, CHAMPS has been used with younger and racially/ethnically diverse populations; it is sensitive to change specifically in Latino and other populations including ones younger than senior age. The CHAMPS asks about activities undertaken for exercise, daily activities that are physical in nature, and physically active recreational activities during "a typical week in the past 4 weeks."

    0 weeks and 4 weeks

  • Change in Physical Activity at 8 Weeks

    The Community Healthy Activities Model Program for Seniors (CHAMPS) is a 41-item physical questionnaire that measures self-reported minutes-per-week of physical activity calculated as total weekly caloric expenditure in all physical activity. Hours and minutes per week were assessed for different types of physical activity. Using body weight and minutes of physical activity (by type), total caloric expenditure was calculated. Data is presented as a T-score with higher values (positive) indicating more calories expended at 8 weeks compared to baseline. Range = 2.5-145.2 kilocalories/kg/hr in the World Walking App condition; range = 6.9-120.1 kilocalories/kg/hr in the Caminemos condition. This measure was administered at 8 weeks to measure changes in physical activity.

    Mean change between 0 and 8 week

Secondary Outcomes (5)

  • Perceived Receipt of Social Support for Exercise at 4 Weeks

    4 weeks

  • Perceived Receipt of Social Support for Exercise at 8 Weeks

    8 weeks

  • Functional Health and Well-being at 4 Weeks

    4 weeks

  • Functional Health and Well-being at 8 Weeks

    8 weeks

  • System Usability Scale (SUS)

    8 weeks

Study Arms (2)

Caminemos Juntas App

EXPERIMENTAL

Participants use the Caminemos app.

Other: Caminemos Juntas App

World Walking App

ACTIVE COMPARATOR

Participants use the World of Walking App.

Other: World Walking App

Interventions

A tailored mobile app that encourages Latinas and Hispanic women to walk together using location-based services.

Caminemos Juntas App

A mobile app that encourages users to walk.

World Walking App

Eligibility Criteria

Age18 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between the ages of 18 and 69 years, identify as Hispanic or Latina, identify as a woman, able to read and speak either English or Spanish, own a smartphone, not pregnant, consent to participate

You may not qualify if:

  • Not between the ages of 18 and 69 years, not identify as Hispanic or Latina, not identify as a woman, unable to read or speak Spanish or English, pregnant, not own a smartphone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University

Stanford, California, 94305-5405, United States

Location

Klein Buendel, Inc.

Golden, Colorado, 80401, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. David Buller
Organization
Klein Buendel, Inc.

Study Officials

  • Valerie Myers, PhD

    Senior Scientist

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2018

First Posted

February 26, 2019

Study Start

February 28, 2019

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

July 14, 2023

Results First Posted

July 14, 2023

Record last verified: 2023-06

Locations