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

Inactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512419
• Other study ID #: Activo R21
• Secondary ID: R21NR014911
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Inactivity

Intervention

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.
• Health Education Control Arm
Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity.

Device:
• Actigraph GT3X

Locations

Country	Name	City	State
United States	University of California San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Self Reported Min/Week of MVPA	Self reported physical activity (collected via 7 day PAR)	baseline and 6 months