CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
EAM +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02554435
NCT02554435N/ACompleted

TAME Health: Testing Activity Monitors' Effect on Health

The University of Texas Medical Branch, Galveston·interventional·Posted Sep 18, 2015·Updated Jul 20, 2020

In Brief

A clinical study evaluating EAM, 5 A's counseling, and 1 other intervention for Physical Activity. Completed, enrolled 40 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 18, 2015
Enrollment StartJan 1, 2016
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.8 years ago

Interventions

EAMdevice

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.

5 A's counselingbehavioral

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.

Pedometerdevice

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.