TAME Health: Testing Activity Monitors' Effect on Health

NCT02554435 | Completed Results

• 1 other identifier: 15-0014
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Physical Activity

Keywords

physical activity; activity monitor; older adults; 5 A's counseling

Outcome Measures

Primary Outcomes (4)

• Physical Activity Minutes Measured by a SenseWear Armband

  Minutes of moderate-vigorous physical activity over a 7 day period

  Physical activity minutes at the end of the 12 week intervention

• Composite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk Calculator

  Factors within the risk calculator include of age in years, systolic blood pressure, gender, and body mass index. These factors are used to create a composite score to estimate the individual's risk for a cardiac event within the next 10 years. The risk score is not bound by maximums and minimums, however a lower number is more favorable. Among women, a composite risk score of 10 equates to a 6% risk of a cardiovascular event, a risk score of 15 equates to a 13% risk, a risk score of 20 equates to a 28.5% risk, and a risk score of 21 or higher equates to \>30% risk of a cardiovascular event within the next 10 years. Among men, a composite risk score of 10 equates to a 9% risk, a risk score of 15 equates to a 21.5% risk, and a risk score of 18 or higher equates to \>30% risk of a cardiovascular event within the next 10 years.

  Cardiovascular risk at the end of the 12 week intervention

• 6-minute Walk Test

  distance walked in 6 minutes

  Fitness at the end of the 12 week intervention

• Steps Per Day

  Measured by a SenseWear Armband. Average steps per day over a 7 day period

  Steps per day at the end of the 12 week intervention

Secondary Outcomes (10)

• Weight

  Weight at the end of the 12 week intervention

• Body Mass Index (BMI)

  BMI at the end of the 12 week intervention

• Waist-to-Hip Ratio

  Waist-to-hip ratio at the end of the 12 week intervention

• Blood Pressure

  Blood pressure at the end of the 12 week intervention

• Exercise Motivation

  Exercise motivation at the end of the 12 week intervention

Study Arms (2)

Pedometer

ACTIVE COMPARATOR

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.

Behavioral: 5 A's counseling; Device: Pedometer

Electronic Activity Monitor (EAM)

EXPERIMENTAL

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.

Device: EAM; Behavioral: 5 A's counseling

Interventions

EAM DEVICE

The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.

Also known as: UP24, Jawbone, Electronic Activity Monitor

Electronic Activity Monitor (EAM)

5 A's counseling BEHAVIORAL

Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.

Electronic Activity Monitor (EAM); Pedometer

Pedometer DEVICE

The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.

Pedometer

Eligibility Criteria

• Age: 55 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• American Heart Association: collaborator

Study Sites (2)

Primary Care Pavilion

Galveston, Texas, 77551, United States

Location

Victory Lakes Town Center

League City, Texas, 77573, United States

Location

Related Publications (3)

• 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.

  PMID: 27129602 BACKGROUND

• 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.

  PMID: 32961834 DERIVED

• 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.

  PMID: 28807041 DERIVED

Related Links

• TAME health protocol citation

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Zakkoyya Lewis
• Organization: California State Polytechnic University, Pomona

drkoyyalewis@gmail.com

5628819950

Study Officials

• Zakkoyya Lewis, BS

  The University of Texas Medical Branch

  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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: September 18, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 20, 2020
• Results First Posted: July 10, 2018

Record last verified: 2018-05

Locations

US (2)