Clinical trial NCT01869348: IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial
Official title: IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Disease
Cancer
Diabetes
Sarcopenia
Keywords: Physical activity
Activity monitor
Technology
Obesity
Aging muscle
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Physical Activity From Baseline to 12 Weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Sedentary Behavior From Baseline to 12 Weeks
timeFrame: 12 weeks
measure: Change in Autonomous Motivation From Baseline to 12 Weeks
timeFrame: 12 weeks
measure: Change in Physical Fitness From Baseline to 12 Weeks
timeFrame: 12 weeks
measure: Change in Body Composition From Baseline to 12 Weeks
timeFrame: 12 weeks
measure: Change in Physical Function From Baseline to 12 Weeks
timeFrame: 12 weeks
measure: Change in Weight From Baseline to 12 Weeks
timeFrame: 12 weeks
Other outcomes:
measure: Feasibility
timeFrame: 12 weeks
measure: Acceptability
timeFrame: 12 weeks
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
Study officials:
affiliation: The University of Texas Medical Branch
name: Elizabeth J Lyons, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.