IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial (IMPACT)

May 10, 2017 updated by: The University of Texas Medical Branch, Galveston
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Inadequate physical activity and extended bouts of sedentary time are prevalent in adults, increasing from middle age into older adulthood. Even small changes in behavior, such as standing or walking in place periodically to break up sedentary bouts, can have large effects on cardiometabolic risk factors. Pedometer-based walking interventions have demonstrated effectiveness in increasing physical activity in this population, but these interventions have not targeted sedentary behavior. Recent technological advances have produced activity monitors that are capable of intervening on both behaviors. These wrist-worn monitors provide feedback and motivation for walking as well as cues to action in the form of idle alerts. These idle alerts vibrate when the wearer has remained sedentary for an extended period of time. Several preliminary studies have shown that older adults are willing to break up their sedentary time if prompted, but interventions thus far have relied upon television commercials as a cue to action. Use of these monitors would allow idle alerts to occur throughout the day, not only during television watching periods. The purpose of the IMPACT study (Inactivity Monitoring and Physical Activity Controlled Trial) is to investigate the feasibility of using activity monitors to simultaneously target both physical activity and sedentary behavior. First, we will conduct a pre-pilot test (N = 10) over six weeks. This brief study will provide basic feasibility and acceptability information on the monitor, content for weekly sessions, and assessments. Results will be used to refine the intervention for use in a larger pilot two-arm randomized controlled trial (N = 20, 12 weeks). This trial, comparing the intervention to a wait-list control group, will test feasibility, acceptability, and health, behavioral, and psychological outcomes. The primary outcome will be physical activity, operationalized as objectively-measured minutes of moderate-vigorous intensity physical activity over seven days (SenseWear armband). We will also measure cardiorespiratory fitness, physical function, body composition, and psychosocial variables such as autonomous motivation. The results of this innovative project will provide a foundation for future intervention in sedentary behavior and potentially create a large public health impact in a population at unique risk.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77550
        • The University of Texas Medical Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Willing to be randomized to either group

Exclusion Criteria:

  1. Age below 55 or above 79
  2. Unable to read and understand English
  3. Unable to read words in standard applications on a mobile device 5 - 10" large
  4. Unable to find transportation to the study location
  5. Investigator overseeing initial fitness test does not approve participation in the study
  6. Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q, items 1 - 4). Reporting taking medicine for blood pressure on this questionnaire will require a doctor's note to participate.
  7. Unable to walk for exercise (self-report)
  8. Report current symptoms of alcohol or substance dependence
  9. Plans to move away from the Galveston-Houston area or to be out of town for more than 1 week during the study period
  10. Unwillingness to report drugs taken for comorbidities such as hypertension or diabetes
  11. Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
  12. Participant is active (60 minutes of moderate-vigorous intensity activity per week or more)
  13. Participant watches little television (120 minutes per day or less)
  14. BMI is under 25 kg/m2 or over 35 kg/m2
  15. Another member of the household is a participant or staff member on this trial
  16. Currently a participant in a physical activity research trial
  17. Recently (less than six months ago) completed a physical activity research trial
  18. Report a history of orthopedic complications that would prevent optimal participation in the physical activities prescribed (e.g., heel spurs, severe arthritis - may be eligible, but a doctor's note will be required)
  19. Current smoker
  20. Currently uses a Jawbone Up or similar activity monitor device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Wait list control
This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.
Experimental: Monitor intervention
This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls
Behavioral: Monitor intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Physical Activity From Baseline to 12 Weeks
Time Frame: 12 weeks
Minutes of physical activity measured over a seven day period
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Sedentary Behavior From Baseline to 12 Weeks
Time Frame: 12 weeks
Minutes of total sedentary time measured over a seven day period
12 weeks
Change in Autonomous Motivation From Baseline to 12 Weeks
Time Frame: 12 weeks
We will measure feelings of autonomous and controlled motivation/regulation for physical activity
12 weeks
Change in Physical Fitness From Baseline to 12 Weeks
Time Frame: 12 weeks
We will use the six minute walk test to measure physical fitness
12 weeks
Change in Body Composition From Baseline to 12 Weeks
Time Frame: 12 weeks
We will use dual x-ray absorptiometry (DEXA) to measure body composition, including body fat percentage and lean mass
12 weeks
Change in Physical Function From Baseline to 12 Weeks
Time Frame: 12 weeks
Functional measurements will be made using the Senior Fitness Test
12 weeks
Change in Weight From Baseline to 12 Weeks
Time Frame: 12 weeks
We will measure weight (and height at baseline) using a calibrated scale
12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 12 weeks
Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability
12 weeks
Feasibility
Time Frame: 12 weeks
We will use many different measures of feasibility, including adherence to study protocol, attrition, barriers to adherence, exposure/dose of intervention received, and any adverse events that occur
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Medical Branch, Galveston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth J Lyons, PhD, MPH, The University of Texas Medical Branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13-071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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