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

Primary Purpose

Obesity, Cardiovascular Disease, Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Monitor intervention
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Physical activity, Activity monitor, Technology, Obesity, Aging muscle

Eligibility Criteria

55 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Texas Medical Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Wait list control

Monitor intervention

Arm Description

This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the 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

Outcomes

Primary Outcome Measures

Change in Physical Activity From Baseline to 12 Weeks
Minutes of physical activity measured over a seven day period

Secondary Outcome Measures

Change in Sedentary Behavior From Baseline to 12 Weeks
Minutes of total sedentary time measured over a seven day period
Change in Autonomous Motivation From Baseline to 12 Weeks
We will measure feelings of autonomous and controlled motivation/regulation for physical activity
Change in Physical Fitness From Baseline to 12 Weeks
We will use the six minute walk test to measure physical fitness
Change in Body Composition From Baseline to 12 Weeks
We will use dual x-ray absorptiometry (DEXA) to measure body composition, including body fat percentage and lean mass
Change in Physical Function From Baseline to 12 Weeks
Functional measurements will be made using the Senior Fitness Test
Change in Weight From Baseline to 12 Weeks
We will measure weight (and height at baseline) using a calibrated scale

Full Information

First Posted
May 24, 2013
Last Updated
May 10, 2017
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT01869348
Brief Title
IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial
Acronym
IMPACT
Official Title
IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
April 15, 2016 (Actual)
Study Completion Date
April 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Cardiovascular Disease, Cancer, Diabetes, Sarcopenia
Keywords
Physical activity, Activity monitor, Technology, Obesity, Aging muscle

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wait list control
Arm Type
No Intervention
Arm Description
This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.
Arm Title
Monitor intervention
Arm Type
Experimental
Arm Description
This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls
Intervention Type
Behavioral
Intervention Name(s)
Monitor intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Physical Activity From Baseline to 12 Weeks
Description
Minutes of physical activity measured over a seven day period
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Sedentary Behavior From Baseline to 12 Weeks
Description
Minutes of total sedentary time measured over a seven day period
Time Frame
12 weeks
Title
Change in Autonomous Motivation From Baseline to 12 Weeks
Description
We will measure feelings of autonomous and controlled motivation/regulation for physical activity
Time Frame
12 weeks
Title
Change in Physical Fitness From Baseline to 12 Weeks
Description
We will use the six minute walk test to measure physical fitness
Time Frame
12 weeks
Title
Change in Body Composition From Baseline to 12 Weeks
Description
We will use dual x-ray absorptiometry (DEXA) to measure body composition, including body fat percentage and lean mass
Time Frame
12 weeks
Title
Change in Physical Function From Baseline to 12 Weeks
Description
Functional measurements will be made using the Senior Fitness Test
Time Frame
12 weeks
Title
Change in Weight From Baseline to 12 Weeks
Description
We will measure weight (and height at baseline) using a calibrated scale
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Feasibility
Description
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
Time Frame
12 weeks
Title
Acceptability
Description
Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Willing to be randomized to either group Exclusion Criteria: Age below 55 or above 79 Unable to read and understand English Unable to read words in standard applications on a mobile device 5 - 10" large Unable to find transportation to the study location Investigator overseeing initial fitness test does not approve participation in the study 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. Unable to walk for exercise (self-report) Report current symptoms of alcohol or substance dependence Plans to move away from the Galveston-Houston area or to be out of town for more than 1 week during the study period Unwillingness to report drugs taken for comorbidities such as hypertension or diabetes Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months Participant is active (60 minutes of moderate-vigorous intensity activity per week or more) Participant watches little television (120 minutes per day or less) BMI is under 25 kg/m2 or over 35 kg/m2 Another member of the household is a participant or staff member on this trial Currently a participant in a physical activity research trial Recently (less than six months ago) completed a physical activity research trial 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) Current smoker Currently uses a Jawbone Up or similar activity monitor device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth J Lyons, PhD, MPH
Organizational Affiliation
The University of Texas Medical Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31518281
Citation
Lewis ZH, Swartz MC, Martinez E, Lyons EJ. Social Support Patterns of Middle-Aged and Older Adults Within a Physical Activity App: Secondary Mixed Method Analysis. JMIR Aging. 2019 Aug 23;2(2):e12496. doi: 10.2196/12496.
Results Reference
derived
PubMed Identifier
28264796
Citation
Lyons EJ, Swartz MC, Lewis ZH, Martinez E, Jennings K. Feasibility and Acceptability of a Wearable Technology Physical Activity Intervention With Telephone Counseling for Mid-Aged and Older Adults: A Randomized Controlled Pilot Trial. JMIR Mhealth Uhealth. 2017 Mar 6;5(3):e28. doi: 10.2196/mhealth.6967.
Results Reference
derived

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IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial

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