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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02512419
Enrollment
48
Registered
2015-07-30
Start date
2015-07-31
Completion date
2017-12-31
Last updated
2019-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inactivity

Keywords

Physical Activity, Latinos, Mexican American Men, Spanish-Language, Text-Message

Brief 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.

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.

Interventions

BEHAVIORALText-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.

BEHAVIORALHealth Education Control Arm

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

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Objectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+Baseline and 6 monthsParticipants 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.
Self Reported Min/Week of MVPAbaseline and 6 monthsSelf reported physical activity (collected via 7 day PAR)

Countries

United States

Participant flow

Participants by arm

ArmCount
Text-Enhanced Physical Activity Intervention Arm
The Spanish-language Physical Activity 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). 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. Actigraph GT3X
22
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. Health Education Control Arm: Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity. Actigraph GT3X
24
Total46

Baseline characteristics

CharacteristicText-Enhanced Physical Activity Intervention ArmTotalHealth Education Control Arm
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants1 Participants1 Participants
Age, Categorical
Between 18 and 65 years
22 Participants45 Participants23 Participants
Age, Continuous44.23 years
STANDARD_DEVIATION 10.34
43.04 years
STANDARD_DEVIATION 10.67
41.96 years
STANDARD_DEVIATION 11.07
Ethnicity (NIH/OMB)
Hispanic or Latino
22 Participants46 Participants24 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Objectively Measured Physical Activity10 minutes/week10.5 minutes/week21 minutes/week
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
4 Participants10 Participants6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants14 Participants7 Participants
Race (NIH/OMB)
White
11 Participants21 Participants10 Participants
Region of Enrollment
United States
22 participants46 participants24 participants
Self-Reported Physical Activity10 minutes/week10 minutes/week5 minutes/week
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
22 Participants46 Participants24 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 220 / 24
other
Total, other adverse events
0 / 220 / 24
serious
Total, serious adverse events
0 / 220 / 24

Outcome results

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.

Time frame: Baseline and 6 months

ArmMeasureGroupValue (MEDIAN)
Text-Enhanced Physical Activity Intervention ArmObjectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+Baseline10 minutes/week
Text-Enhanced Physical Activity Intervention ArmObjectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+6 Months57.5 minutes/week
Health Education Control ArmObjectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+Baseline21 minutes/week
Health Education Control ArmObjectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+6 Months23 minutes/week
Comparison: To examine potential intervention effects on the primary outcome (MVPA at 6 months), we used a series of quantile regression models which model median outcome at follow-up as a function of baseline value of the outcome (MVPA), treatment condition and covariates. Note that the adjusted difference in median MVPA between conditions at follow-up will not equal the difference in median minutes as seen in the unadjusted tables as these estimates are adjustedp-value: 0.04quantile regression
Primary

Self Reported Min/Week of MVPA

Self reported physical activity (collected via 7 day PAR)

Time frame: baseline and 6 months

ArmMeasureGroupValue (MEDIAN)
Text-Enhanced Physical Activity Intervention ArmSelf Reported Min/Week of MVPA6 Months95 min/week
Text-Enhanced Physical Activity Intervention ArmSelf Reported Min/Week of MVPABaseline10 min/week
Health Education Control ArmSelf Reported Min/Week of MVPABaseline5 min/week
Health Education Control ArmSelf Reported Min/Week of MVPA6 Months52.5 min/week
Comparison: Quantile regression was used.p-value: 0.1quantile regression

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026