Clinical trial NCT02554435: TAME Health: Testing Activity Monitors' Effect on Health
Official title: TAME Health: Testing Activity Monitors' Effect on Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: physical activity
activity monitor
older adults
5 A's counseling
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2015-09-18
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Physical Activity Minutes Measured by a SenseWear Armband
timeFrame: Physical activity minutes at the end of the 12 week intervention
measure: Composite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk Calculator
timeFrame: Cardiovascular risk at the end of the 12 week intervention
measure: 6-minute Walk Test
timeFrame: Fitness at the end of the 12 week intervention
measure: Steps Per Day
timeFrame: Steps per day at the end of the 12 week intervention
Secondary outcomes:
measure: Weight
timeFrame: Weight at the end of the 12 week intervention
measure: Body Mass Index (BMI)
timeFrame: BMI at the end of the 12 week intervention
measure: Waist-to-Hip Ratio
timeFrame: Waist-to-hip ratio at the end of the 12 week intervention
measure: Blood Pressure
timeFrame: Blood pressure at the end of the 12 week intervention
measure: Exercise Motivation
timeFrame: Exercise motivation at the end of the 12 week intervention
measure: Quality of Life Measured by the SF-36 Questionnaire
timeFrame: Quality of life at the end of the 12 week intervention
measure: Physical Function Measured by the Short Physical Performance Battery
timeFrame: Physical function at the end of the 12 week intervention
measure: Psychological Feelings
timeFrame: Psychological feelings at the end of the 12 week intervention
measure: Resting Pulse
timeFrame: Resting pulse at the end of the 12 week intervention
measure: Change From Baseline in Self-regulation
timeFrame: Change in self-regulation from baseline and 12-weeks
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Primary Care Pavilion
state: Texas
city: League City
country: United States
facility: Victory Lakes Town Center
state: Texas
Study officials:
affiliation: The University of Texas Medical Branch
name: Zakkoyya Lewis, BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lewis ZH, Ottenbacher KJ, Fisher SR, Jennings K, Brown AF, Swartz MC, Lyons EJ. Testing Activity Monitors' Effect on Health: Study Protocol for a Randomized Controlled Trial Among Older Primary Care Patients. JMIR Res Protoc. 2016 Apr 29;5(2):e59. doi: 10.2196/resprot.5454.
citation: Lewis ZH, Ottenbacher KJ, Fisher SR, Jennings K, Brown AF, Swartz MC, Martinez E, Lyons EJ. Effect of Electronic Activity Monitors and Pedometers on Health: Results from the TAME Health Pilot Randomized Pragmatic Trial. Int J Environ Res Public Health. 2020 Sep 18;17(18):6800. doi: 10.3390/ijerph17186800.
citation: Lewis ZH, Ottenbacher KJ, Fisher SR, Jennings K, Brown AF, Swartz MC, Martinez E, Lyons EJ. The feasibility and RE-AIM evaluation of the TAME health pilot study. Int J Behav Nutr Phys Act. 2017 Aug 14;14(1):106. doi: 10.1186/s12966-017-0560-5.