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NCT02554435 · ClinicalTrials.gov registry record · NA

TAME Health: Testing Activity Monitors' Effect on Health

A NA study of Physical Activity, sponsored by The University of Texas Medical Branch, Galveston.

Completed
Registry status
NA
Development phase
40
Enrollment target
2
Study locations

NCT02554435 is a NA study of Physical Activity that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 40 participants, below the 358-participant average among 131 other Physical Activity trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT02554435, a NA study of Physical Activity, has completed, sponsored by The University of Texas Medical Branch, Galveston.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target
2
Study locations

Study 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 Studied

Interventions

  • DEVICE Pedometer
  • DEVICE EAM
  • BEHAVIORAL 5 A's counseling

Study Locations (2)

Texas

  • Primary Care Pavilion - Galveston
  • Victory Lakes Town Center - League City

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2016-01
Est. Completion 2016-09
Phase NA

What the Registry Record Tells You About NCT02554435

The ClinicalTrials.gov registry entry for NCT02554435 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 358-participant average among 131 other Physical Activity trials with a reported enrollment target (89% lower). The listed sponsor is The University of Texas Medical Branch, Galveston, which has 203 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Physical Activity appearing as the primary indexed condition, and to 3 interventions - of which Pedometer is the first listed.

NCT02554435 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT02554435 about?

NCT02554435 is a clinical study titled "TAME Health: Testing Activity Monitors' Effect on Health". 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 prevent...

What is the current status of trial NCT02554435?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2016-01. Estimated completion is 2016-09.

What conditions does trial NCT02554435 study?

This clinical trial studies the following conditions: Physical Activity.

What interventions are being tested in trial NCT02554435?

The interventions under investigation include: Pedometer (DEVICE), EAM (DEVICE), 5 A's counseling (BEHAVIORAL).

Who is sponsoring clinical trial NCT02554435?

This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02554435 being conducted?

This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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