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IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial

55 Years
79 Years
Not Enrolling
Obesity, Cardiovascular Disease, Cancer, Diabetes, Sarcopenia

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Trial Information

IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial

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.

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

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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Change in physical activity from baseline to 12 weeks

Outcome Description:

Minutes of physical activity measured over a seven day period

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Elizabeth J Lyons, PhD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas Medical Branch


United States: Institutional Review Board

Study ID:




Start Date:

June 2013

Completion Date:

August 2014

Related Keywords:

  • Obesity
  • Cardiovascular Disease
  • Cancer
  • Diabetes
  • Sarcopenia
  • Physical activity
  • Activity monitor
  • Technology
  • Obesity
  • Aging muscle
  • Cardiovascular Diseases
  • Obesity
  • Sarcopenia



The University of Texas Medical Branch Galveston, Texas  77555