N/A
N=40
IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial
Obesity · Cardiovascular Disease · Cancer · Diabetes · Sarcopenia
Bottom Line
View on ClinicalTrials.gov: NCT01869348 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Change in Physical Activity From Baseline to 12 Weeks — -2.25; 50.93 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Monitor intervention (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Physical Activity From Baseline to 12 Weeks |
-2.25; 50.93 | — |
| SECONDARY Change in Sedentary Behavior From Baseline to 12 Weeks |
— | — |
| SECONDARY Change in Autonomous Motivation From Baseline to 12 Weeks |
— | — |
| SECONDARY Change in Physical Fitness From Baseline to 12 Weeks |
— | — |
| SECONDARY Change in Body Composition From Baseline to 12 Weeks |
— | — |
| SECONDARY Change in Physical Function From Baseline to 12 Weeks |
— | — |
| SECONDARY Change in Weight From Baseline to 12 Weeks |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01869348). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.