Clinical trial NCT02622282: Text Messaging to Promote Walking Among Latino Adults at Risk for Peripheral Arterial Disease
Official title: Text Messaging to Promote Walking Among Latino Adults at Risk for PAD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: physical activity
physical inactivity
PAD
Diabetes
High blood pressure
High cholesterol
Smoking
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2015-12-04
Enrollment: 69
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Physical Activity
timeFrame: Change from Baseline to 3 Months
Secondary outcomes:
measure: Change in Exercise Behavior
timeFrame: Change from Baseline to 3 Months
measure: Change in Quality of Life
timeFrame: Change from Baseline to 3 Months
Other outcomes:
Locations:
city: Wichita
country: United States
facility: KU School of Medicine - Wichita
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Tracie C. Collins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.