CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Monitor interventionbehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01869348
NCT01869348N/ACompleted

IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial

The University of Texas Medical Branch, Galveston·interventional·Posted Jun 5, 2013·Updated Oct 4, 2017

In Brief

A clinical study evaluating Monitor intervention for Obesity and 4 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed Summary

As individuals age, their physical activity decreases and sedentary time increases. Even small changes in these two behaviors can greatly decrease risks for several major health problems, including cardiovascular disease, diabetes, and many cancers. Studies that use pedometers to encourage walking have successfully increased physical activity, but do not address sedentary behaviors such as television watching. The investigators propose to use a novel pedometer-like device (Jawbone Up) that encourages both increased physical activity and decreased sedentary time. First, the investigators will recruit 10 adults to participate in a brief intervention for six weeks. They will wear the wrist-based activity monitor and use a mini-tablet device to see feedback on their activity and sedentary time. They will also receive brief counseling weekly. The investigators will use this first study to investigate the basic feasibility of the intervention materials. Next, the investigators will recruit 20 adults and randomize them to receive the intervention for 12 weeks or to a waiting list. Here, the investigators will test the intervention with refinements made based on participant responses from the first small study. Our primary outcomes will be measures of feasibility and acceptability across all parts of the study. The investigators hypothesize that the intervention will be feasible and acceptable to the participants. The investigators will also measure physical activity, sedentary behavior, fitness, body fat, and psychological feelings of motivation.

Study Details

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

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 5, 2013
Enrollment StartJun 1, 2014
Primary CompletionApr 15, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.1 years ago

Interventions

Monitor interventionbehavioral

Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide "idle alerts" that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior.