Clinical trial NCT03196570: Increasing Physical Activity in Latino Men
Official title: Increasing Physical Activity in Latino Men Through Tailoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2017-06-23
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the feasibility and preliminary efficacy of a web and text-messaged based intervention designed to increase physical activity among Latino men in Rhode Island. The study will also examine potential moderators of treatment effects including demographics, acculturation, and environmental variables such as the neighborhood built, social and economic environments.

Detailed description: Physical Activity in Latino Men Through Tailoring is an individually randomized web and text message based pilot study, designed to increase physical activity amongst Latino men. The study is conducting formative research with a diverse population of Latino men to inform the adaptation of the Pasos Hacia La Salud web-based intervention, which was developed for Latina women, to an intervention focused on Latino men. Consideration will also be taken to ensure intervention material is culturally appropriate for Latino men of Caribbean, South and Central American origin. Half the study participants will be randomized into the intervention arm and half into the comparison group. Participants in the intervention arm will have access to a website where they can complete questionnaires, receive information, log their physical activity and set goals. Participants complete monthly questionnaires to establish their stage of change toward increasing their physical activity and receive information manuals based on their current stage of change. They will also have access to tip sheets via the study website and receive reoccurring text messages reminding them to log into the website. Participants in the comparison arm will have access to a similar website with information related to nutrition and overall wellness, not including physical activity.

The primary aims of this project are (1) to conduct formative research with a diverse population of RI Latino men to adapt the existing web-based interventions and add text message-based components to complement and enhance the intervention. The second primary aim is to determine the feasibility, acceptability, and preliminary efficacy of the intervention and the study recruitment, implementation and evaluation protocols with a diverse population of Latino men. An additional exploratory aim will be to examine potential moderators of treatment effects including demographics, acculturation, and environmental variables such as the neighborhood built, social and economic environments. The hypothesis is that participants randomized to the intervention condition will have greater increases in weekly minutes of physical activity after six months than those randomized to a wellness control condition. The results of this pilot study will inform a future randomized controlled trial with Latino men to increase PA.

Eligibility criteria: Inclusion Criteria:

* Be sedentary ( participate in moderate intensity leisure time PA two days a week for less than 30 minutes a day, or less)
* Identify as a Latino male
* Speak Spanish
* Score of more than 16% on Spanish Shortened Test of Functional Health Literacy in Adults
* Own a cell phone with texting capabilities and have internet access

Exclusion Criteria:

* History of myocardial infarction or angina, insulin-dependent diabetes or hospitalization for diabetes in the past year, stroke, osteoarthritis, osteoporosis, orthopedic problems, or any medical condition that would make PA unsafe.
* Planning to move from the area in the next 6 months
* Hospitalization due to a psychiatric disorder in the past 3 years.
* BMI of 45 or higher and/or taking any medication that may impair PA tolerance or performance.
* If they or another family member is already enrolled in another PA or weight control study.

Primary outcomes:
measure: Change in Physical Activity from Baseline to 6 months
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
References:
citation: Gans KM, Dulin A, Palomo V, Benitez T, Dunsiger S, Dionne L, Champion G, Edgar R, Marcus B. A Tailored Web- and Text-Based Intervention to Increase Physical Activity for Latino Men: Protocol for a Randomized Controlled Feasibility Trial. JMIR Res Protoc. 2021 Jan 29;10(1):e23690. doi: 10.2196/23690.