Clinical trial NCT03491592: Web-based Physical Activity Intervention for Latinas
Official title: Promoting Physical Activity in Latinas Via Interactive Web-based Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inactivity
Keywords: Physical Activity
Latinas
Spanish-language
Text-Message
Exercise
Web-based
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2018-04-09
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This renewal builds upon our successful culturally adapted PA intervention for Latinas (Pasos Hacia La Salud, R01CA159954) and expands its focus to the critical area of maintenance of behavior change. This study will test an enhanced version of the original internet intervention in order to achieve greater increases in PA and longer term maintenance. Investigators propose to test this newly developed enhanced intervention (Enhanced Intervention) compared to the original Pasos Hacia La Salud Intervention (Original Intervention) in a 24-month randomized trial (N=300).

Detailed description: In the U.S., Latina women report higher rates of inactivity than their non-Hispanic White and male counterparts, and are disproportionately affected by related health conditions (e.g., cancer, hypertension, heart disease, stroke, diabetes). To address this public health crisis, evidence-based interventions that utilize state-of-the-art technology, theory and methods are needed to increase physical activity (PA) among this high-risk population. Recently, our team conducted a randomized controlled trial (N=205) to test the efficacy of a 6-month culturally adapted, individually tailored, Spanish-language Internet-based PA intervention among Latinas (Pasos Hacia La Salud, R01CA159954) vs. a Wellness Contact Control Internet Group. Increases in minutes/week of moderate-to-vigorous physical activity (MVPA) were significantly greater in the Intervention Group compared to the Control Group at 6 and 12 months (p \< .01) but still did not reach levels recommended in the national physical activity guidelines. As improvements in PA in the Intervention Group were significantly associated with website use and increases in self-efficacy, enjoyment, and social support in the parent study, we used these data to inform technology and theory-supported enhancements to the intervention (i.e., text messaging and adaptive goal setting to increase website use and further targeting of the previously mentioned key psychosocial constructs) to achieve even greater increases in PA, and maintain these gains over the long term (24 months) in the renewal of R01CA159954. For the proposed study, 300 Latina women will be randomized to either 1) the original Pasos Hacia La Salud tailored Internet-based PA intervention (Original Intervention) or 2) the data driven, enhanced version of the Pasos Hacia La Salud PA intervention (Enhanced Intervention). We hypothesize that participants in the Enhanced Intervention arm will report significantly more minutes/week of MVPA than participants in the Original Intervention arm at 6 months. We will also examine the maintenance of treatment effects at 12, 18, and 24 months, as well as the costs of delivering the Enhanced vs. Original Intervention programs, and the potential mediators of the intervention-PA relationship. The proposed high reach, low-cost intervention holds great promise in promoting and maintaining the positive health benefits of PA in the lives of Latina women in the United States.

Eligibility 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)
* 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
* 18 - 65 years of age
* Daily access to a text-message compatible cell phone and to an Internet-connected device through home, work, or their community

Exclusion Criteria:

* History of coronary heart disease (history of myocardial infarction or symptoms of angina),
* Diabetes that requires insulin and does not have a doctor's approval
* Chronic infectious disease- HIV, Hepatitis C but does not have doctor approval
* Orthopedic conditions which limit mobility, any other serious medical condition that would make PA unsafe (based on modified Physical Activity Readiness Questionnaire)
* Hospitalization due to a psychiatric disorder in the past 3 years
* BMI above 45 kg/m2
* Current or planned pregnancy in the next two year
* Moving from area within two years
* Does not have a cellphone capable of sending and receiving text messages
* Not able to receive materials in the mail, either at your own home or at a mailbox

Primary outcomes:
measure: Change in total weekly minutes of physical activity as measured by an accelerometer
timeFrame: Baseline, 6 months, 12, 18 and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: 121 South Main Street, Brown University
state: Rhode Island
Study officials:
References:
citation: Mendoza-Vasconez AS, Benitez T, Dunsiger S, Gans KM, Hartman SJ, Linke SE, Larsen BA, Pekmezi D, Marcus BH. Pasos Hacia La Salud II: study protocol for a randomized controlled trial of a theory- and technology-enhanced physical activity intervention for Latina women, compared to the original intervention. Trials. 2022 Aug 1;23(1):621. doi: 10.1186/s13063-022-06575-4.