Increasing Physical Activity in Latino Men

NCT03196570 | Completed

• 1 other identifier: 1612001664
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (1)

• Change in Physical Activity from Baseline to 6 months

  Minutes of Moderate and Vigorous Physical Activity

  Baseline and 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Physical Activity Intervention

Contact Control

ACTIVE COMPARATOR

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.

Behavioral: Wellness Contact Control

Interventions

Physical Activity Intervention BEHAVIORAL

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.

Intervention

Wellness Contact Control BEHAVIORAL

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.

Contact Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Connecticut: lead
• Brown University: collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

Related Publications (2)

• Dulin AJ, Dunsiger S, Benitez T, Larsen B, Marcus BH, Champion G, Gans KM. The Hombres Saludables Physical Activity Web-Based and Mobile Phone Intervention: Pilot Randomized Controlled Trial With Latino Men. J Med Internet Res. 2023 Dec 7;25:e39310. doi: 10.2196/39310.

  PMID: 38060285 DERIVED

• 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.

  PMID: 33512327 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 23, 2017
• Study Start: March 12, 2018
• Primary Completion: April 30, 2020
• Study Completion: June 30, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Locations

US (1)