Developing a Text-Message Enhanced Physical Activity Intervention for Latino Men

June 21, 2019 updated by: Dr.Bess Marcus, University of California, San Diego
The aim of this study is to build upon our tailored print intervention by developing new text-delivered intervention materials to complement our print-based physical activity (PA) intervention. In Phase 1 we will conduct 6 focus groups with Mexican and Mexican American (MA) men to determine content, frequency, and types of text messages desired, and to identify cultural themes to incorporate into existing and new materials. Themes from the focus groups and sample text messages will be presented to a confirmatory focus group panel. Phase 2 will be a 6-month pilot randomized controlled trial with Mexican and MA men (N=60) to test the text-enhanced, Spanish language, individually tailored PA intervention vs. publicly available, Spanish language health education materials, including information on PA, diet, and stress management. This will be followed by post-intervention qualitative interviews to solicit suggestions for improvements to help further refine the program. The proposed pilot will support a future R01 to establish the efficacy of this multi-media, multi-level PA intervention for Mexican and MA men.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The proposed research addresses serious public health concerns (inactivity, health disparities) in a large, rapidly growing population of Mexican American (MA) men who are markedly less physically active than men of other ethnicities and suffer from higher prevalence of conditions related to sedentary lifestyle. While this population is clearly in need of physical activity (PA) interventions, to date none have specifically targeted MA men. In fact, the majority of PA interventions for Latinos have exclusively included women and/or are designed around female preferences.The proposed study will address the needs and barriers to PA in MA men by developing text message-delivered intervention materials based on Social Cognitive Theory (SCT) to complement an individually tailored, theory-based print material PA intervention for Spanish speaking Mexican and MA men. Text messaging could be a particularly effective and appealing channel for increasing PA in this target population as it allows for participant interaction, real-time accountability, and immediate feedback, features which MA men in the demonstration trial of our print intervention specifically requested. Text-based interventions have been shown to improve a number of health behaviors, including PA. A recent review of texting interventions found that they were generally well received and effective in reducing inactivity, weight, and waist circumference,5 and a meta-analysis found a moderate effect size (g = 0.54) for using mobile devices to increase PA. However, few of these trials targeted underserved populations, and none specifically targeted Latinos. Cell phone ownership is high in Latino adults (86% vs. 84% in non-Latino Whites), and Latinos are actually the most likely to use mobile phones for text messaging, with 85% reporting regularly sending and receiving texts (compared to 79% of Whites). Thus this is a familiar, convenient channel for delivering new intervention materials. Additionally, as Latinos also face environmental barriers to PA, in the current proposal we will enhance the individually tailored psychosocial print-based materials by developing materials targeting barriers in home and work environments. This multi-media, multi-level approach has potential for broad reach at relatively low cost, which could help reduce health disparities.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093-0628
        • University of California San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • Generally healthy (If asthma, controlled high blood pressure and/or controlled type II diabetes, may be able to participate with physician consent)
  • Sedentary (Less than 60 minutes per week of moderate or vigorous physical activity)
  • Mexican and/or Mexican American (self-identified)
  • Must be able to read and write Spanish fluently
  • 18 - 65 years of age
  • Planning on living in the area for the next 6 months
  • Own a cell phone capable of sending and receiving text messages

Exclusion Criteria:

  • Body Mass Index(BMI) greater than 45
  • Not able to walk continuously for 30 minutes/limited ability to complete daily activity or ability to exercise
  • Exercise is against advice of doctor
  • Heart disease/treatment
  • Heart murmur
  • Angina/chest pain or Angina/chest pain with exertion
  • Palpitations
  • Stroke/Transient Ischemic Attacks
  • Peripheral Vascular Disease
  • Type I Diabetes
  • Uncontrolled Type II Diabetes
  • Chronic Infectious Disease - HIV, Hepatitis
  • Chronic liver disease
  • Cystic Fibrosis
  • Abnormal EKG on last EKG performed
  • Emphysema, Chronic bronchitis, Chronic Obstructive Pulmonary Disease
  • Seizure in past year
  • Surgery in past year on heart, lung, joint, orthopedic surgery
  • Surgery pending in next year on lung, joint, orthopedic surgery
  • Unusual/concerning shortness of breath
  • Asthma (may be able to participate with physician consent)
  • High blood pressure/high blood pressure medication (may be able to participate with physician consent)
  • Use of beta blockers
  • Abnormal Medical Stress Test
  • Musculoskeletal problems
  • Fainting/dizziness more than 3 times in past year OR interferes with daily activities OR causes loss of balance
  • Cancer treatment in past 3 months
  • Hospitalized for psychiatric disorder in past 3 years or suicidal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Text-Enhanced Physical Activity Intervention Arm
The Spanish-language PA intervention is based on Social Cognitive Theory (SCT) and Transtheoretical Model (TTM), and emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals).
Behavioral: Text-Enhanced Physical Activity Intervention Arm
Participants in the Text-Enhanced Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, print-based + text-message physical activity intervention that specifically addresses the physical activity barriers and intervention needs/preferences of Mexican and Mexican American men.
Device: Actigraph GT3X
Active Comparator: Health Education Control Arm
The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management.
Device: Actigraph GT3X
Behavioral: Health Education Control Arm
Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+
Time Frame: Baseline and 6 months
Participants will wear an Actigraph GT3X+ accelerometer, which measures movement and intensity of activity and has been validated against heart rate telemetry and total energy expenditure.
Baseline and 6 months
Self Reported Min/Week of MVPA
Time Frame: baseline and 6 months
Self reported physical activity (collected via 7 day PAR)
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Activo R21
  • R21NR014911 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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