TAME Health: Testing Activity Monitors' Effect on Health

The University of Texas System (UT)

Status: Completed

Conditions: Physical Activity

Treatments: Behavioral: 5 A's counseling; Device: EAM; Device: Pedometer

Study type: Interventional

Funder types: Other

Identifiers

NCT02554435

15-0014

Details and patient eligibility

About

Cardiovascular disease accounts for 1 in 3 deaths among US adults and is strongly related to physical activity. Most older adults do not participate in healthy levels of physical activity. Physical activity promotion and counseling from a primary health care provider is important for disease prevention. In addition to counseling, an activity monitor can increase physical activity through self-regulation. Two types of monitors are available: pedometers and electronic activity monitors (EAMs). Research shows that both monitors are motivational devices that can increase physical activity. Pedometers count steps of the wearer. EAMs can monitor steps, monitor burned calories, quality of sleep, and sedentary time. EAMs may also offer more behavioral change techniques and opportunities for self-monitoring. The goal of this study is to compare the effectiveness of EAMs compared to a pedometer on increasing physical activity and decreasing cardiovascular risk within older adult, primary care patients. The study will include sedentary, overweight primary care patients, 55-74 years of age with access to a smart phone or tablet. All participants will receive brief physical activity counseling. Participants will then be randomized to receive a self-monitoring device (Digi-walker CW-700/701 or UP24 by Jawbone) to wear for 3 months. Investigators will evaluate the following outcomes: physical activity, cardiovascular risk (Framingham risk calculator, fitness), psychological feeling toward exercise, physical function, health status, exercise motivation and self-regulation. The investigators hypothesize that EAMs will be more effective than pedometers in improving these outcomes. The results of this pilot test will aid in the translation of effective physical activity intervention components to primary care clinics for cardiovascular disease prevention.

Full description

Cardiovascular disease (CVD) is prevalent and the leading cause for mortality in the United States. The American Heart Association's (AHA) 2020 Impact Goal is to improve the cardiovascular health of all Americans by 20 percent while reducing deaths from CVD and stroke by 20 percent. Maintaining healthy levels of physical activity (PA) is critical in maintaining cardiovascular health, but older adults are inactive. Inactivity may be influenced by low levels of motivation. Standard behavioral counseling techniques typically implemented within the primary care setting target increased motivation, but lack the key component of self-control. The addition of electronic activity monitors (EAMs) that provide interactive self-monitoring, feedback, and social support may further increase motivation for exercise by providing more effective behavior change techniques than standard protocols. Investigators will conduct a three month intervention trial that will test the feasibility of adding an EAM system to brief counseling within a primary care setting. Participants (N = 40) will be randomized to receive evidence-based brief counseling plus either an EAM or a pedometer. Investigators propose two Specific Aims:

AIM 1: Evaluate the feasibility and acceptability of implementing a technology-enhanced brief intervention to increase physical activity in a primary care setting. Measures of feasibility will include days the EAM was worn, usage of the app, technological problems, attrition, and adverse events. Acceptability will be measured by self-report and focus groups.

AIM 2: Compare the counseling plus EAM intervention to a counseling plus pedometer intervention. Primary outcomes will be changes in PA and cardiovascular risk. We will also investigate secondary outcomes (differences in adherence, weight and body composition, health status, motivation, physical function, psychological feelings, self-regulation).

Enrollment: 40 patients

Sex: All

Ages: 55 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• physically inactive (less than 60 minutes per week)
• BMI between 25-35
• in good health measured by Par-Q+
• access to a smart phone

Exclusion criteria

• physical activity is inadvisable by their doctor
• involved in another physical activity intervention within the past 6 months
• used an activity monitor in the past 6 months
• unwilling to travel for scheduled visits
• currently taking medications that affect body composition
• current smoker
• report alcohol or drug problem
• institutionalized for psychiatric illness within the last year
• do not consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Pedometer

Active Comparator group

Description:

All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.

Treatment:

Behavioral: 5 A's counseling

Device: Pedometer

Electronic Activity Monitor (EAM)

Experimental group

Description:

All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.

Treatment:

Behavioral: 5 A's counseling

Device: EAM