Text Messaging to Promote Walking Among Latino Adults at Risk for Peripheral Arterial Disease

Text Messaging to Promote Walking Among Latino Adults at Risk for PAD

The purpose of this study is to learn about the impact of text messaging on physical activity in persons with risk factors for peripheral arterial disease (PAD).

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Other: Text Messages; Other: Phone Calls; Other: Handout

Detailed Description

Thirty-five million Latinos live in the U.S. and nearly 14% have peripheral arterial disease (PAD) defined as a build-up of plaque in the arteries that supply blood to the legs. Approximately 40% have at least one risk for PAD (i.e., aged 70 years and older, diabetes, high blood pressure, high blood cholesterol, or smoking). Persons with at least one risk factor and who are physically inactive are more likely to suffer from severe PAD. Physical inactivity is highly prevalent in Latinos and a major risk factor for PAD. Physical inactivity affects 50% of Latinos aged 60 years and older.

Participation in this study will last for about 3 months. Participants will be randomized to one of two groups. One group will receive text messages, brief telephone calls, and a handout. The other group will only receive the handout. The study will be looking at how the different groups respond to the different interventions used in the study.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Wichita, Kansas, United States, 67214
      • KU School of Medicine - Wichita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Latino adults
• English or Spanish speaking
• Have one or more of the following: diabetes mellitus, smoking, hypertension, or hyperlipidemia.
• Adults age 70 years or older, regardless of having one or more the above noted risk factors for PAD, will also be eligible for enrollment.

Exclusion Criteria:

• Pregnancy
• Prior major amputation (foot or lower leg) or critical leg ischemia (tissue loss, gangrene, or ulcers)
• Use of supplemental oxygen
• Myocardial infarction within preceding 3 months

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Participants will receive text messages and telephone calls during the length of their participation. Participants will receive a handout with information on PAD and physical activity.	Other: Text Messages; Text messages will be sent one time per day. Text messages will include messages to motivate and inform participants on the importance of walking.; Other: Phone Calls; Participants may receive a telephone call every two weeks for one month followed by once per month for two months.; Other: Handout; Handout includes information specific to participant's condition and ways to promote an active lifestyle.
Active Comparator: Control Group; Participants will receive a handout with information on PAD and physical activity.	Other: Handout; Handout includes information specific to participant's condition and ways to promote an active lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Activity	All participants will use a pedometer. Mean change will be measured based on steps per day.	Change from Baseline to 3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Exercise Behavior	Change will be measured using the Exercise Behaviors Survey.	Change from Baseline to 3 Months
Change in Quality of Life	Change will be measured using the Medical Outcomes Study (MOS) Short Form 36. The survey has 36 questions. Scores are coded based on response by participant. A score of 100 indicates the most favorable situation while a score of 0 would indicate the least favorable.	Change from Baseline to 3 Months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Tracie C. Collins, MD, MPH, University of Kansas Medical Center

Publications and helpful links

General Publications

• Collins TC, Lu L, Valverde MG, Silva MX, Parra-Medina D. Efficacy of a multi-component intervention to promote physical activity among Latino adults: A randomized controlled trial. Prev Med Rep. 2019 Aug 7;16:100965. doi: 10.1016/j.pmedr.2019.100965. eCollection 2019 Dec.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 4, 2015

Study Record Updates

• Last Update Posted (Estimate): February 2, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes; physical activity; PAD; Smoking; High blood pressure; High cholesterol; physical inactivity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: STUDY00003190; R56AG047590 (U.S. NIH Grant/Contract)