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

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: Completed
• Conditions: Inactivity
• Intervention / Treatment: Behavioral: Text-Enhanced Physical Activity Intervention Arm; Device: Actigraph GT3X; Behavioral: Health Education Control Arm

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: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Objectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+	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	Self reported physical activity (collected via 7 day PAR)	baseline and 6 months

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: National Institute of Nursing Research (NINR)

Publications and helpful links

General Publications

• Larsen BA, Benitez TJ, Mendoza-Vasconez AS, Hartman SJ, Linke SE, Pekmezi DJ, Dunsiger SI, Nodora JN, Gans KM, Marcus BH. Randomized Trial of a Physical Activity Intervention for Latino Men: Activo. Am J Prev Med. 2020 Aug;59(2):219-227. doi: 10.1016/j.amepre.2020.03.007. Epub 2020 May 21.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: July 29, 2015
• First Submitted That Met QC Criteria: July 29, 2015
• First Posted (Estimate): July 30, 2015

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: June 21, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Physical Activity; Latinos; Text-Message; Mexican American Men; Spanish-Language
• Other Study ID Numbers: Activo R21; R21NR014911 (U.S. NIH Grant/Contract)