Increasing Physical Activity in Latino Men

Physical Activity Clinical Trial

Official title:

Increasing Physical Activity in Latino Men Through Tailoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196570
• Other study ID #: 1612001664
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2020
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Physical Activity Intervention
After randomization into the intervention arm, participants will be instructed on how to use the Spanish language study website. During the six month intervention, they will complete online questionnaires to determine their stage of change towards increasing physical activity. A manual of information will be automatically generated based on their responses. Participants can read this information online, along with tip sheets related to increasing physical activity. On the website they can also set weekly goals and log their weekly PA. It will also include short videos with demonstrations for PA they can do at home and around their neighborhood. Information will also include community resources (community centers, public events, parks) where they can be physically active. Participants will also receive prompts and encouragement via text-message to encourage them to log into the website and continue to track their progress.
• Wellness Contact Control
Participants in the control arm will attend the same baseline orientation sessions and measurements as the intervention arm. After randomization into the control group, participants will complete an introductory in-person session to introduce them to a website, similar in design, with information on health topics other than physical activity, including diet and other factors associated with CVD risk. It will include information from NHLBI heart health materials for Latinos. Topics include healthy eating, increasing fruit and vegetable consumption, reducing fat and salt intake, learning about cholesterol, stress management. Participants will log onto a separate website unique to the control group and complete monthly surveys on the wellness topics and their progress. Participants will also receive prompts and encouragement text-messages to encourage them to log onto the website.

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Physical Activity from Baseline to 6 months	Minutes of Moderate and Vigorous Physical Activity	Baseline and 6 months