Clinical trial · Interventional
IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cardiovascular Disease | — | UNRESOLVED | — |
| Diabetes | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Sarcopenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Monitor intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Wait list control
- description
- This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.
- type
- EXPERIMENTAL
- label
- Monitor intervention
- 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
- interventionNames
- Behavioral: Monitor intervention
Primary outcomes (1)
- measure
- Change in Physical Activity From Baseline to 12 Weeks
- timeFrame
- 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDLewis 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. PMID 31518281
- DERIVEDLyons 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. PMID 28264796