N/A N=48 Randomized Treatment

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

Inactivity

Bottom Line

View on ClinicalTrials.gov: NCT02512419 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: Objectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+ — 10; 21; 57.5; 23 minutes/week — p=.04

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Text-Enhanced Physical Activity Intervention Arm (Behavioral); Health Education Control Arm (Behavioral); Actigraph GT3X (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: University of California, San Diego
Primary completion: Oct 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Objectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+	10; 21; 57.5; 23	.04 sig
PRIMARY Self Reported Min/Week of MVPA	10; 5; 95; 52.5	0.10

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02512419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.