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

NCT02512419 | Completed Results DMC

• 2 other identifiers: Activo R21R21NR014911
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Inactivity

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Text-Enhanced Physical Activity Intervention Arm

EXPERIMENTAL

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; Device: Actigraph GT3X

Health Education Control Arm

ACTIVE COMPARATOR

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.

Behavioral: Health Education Control Arm; Device: Actigraph GT3X

Interventions

Text-Enhanced Physical Activity Intervention Arm BEHAVIORAL

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.

Text-Enhanced Physical Activity Intervention Arm

Health Education Control Arm BEHAVIORAL

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

Health Education Control Arm

Actigraph GT3X DEVICE

Health Education Control Arm; Text-Enhanced Physical Activity Intervention Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of California San Diego

La Jolla, California, 92093-0628, United States

Location

Related Publications (1)

• 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.

  PMID: 32448552 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Bess Marcus
• Organization: Brown University

bess_marcus@brown.edu

401-863-9858

Study Officials

• Bess H Marcus, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: July 30, 2015
• Study Start: July 1, 2015
• Primary Completion: October 31, 2017
• Study Completion: December 31, 2017
• Last Updated: July 16, 2019
• Results First Posted: July 16, 2019

Record last verified: 2019-06

Locations

US (1)