Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wait list control | No Intervention | This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention. | |
| Monitor intervention | Experimental | This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monitor intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity From Baseline to 12 Weeks | Minutes of physical activity measured over a seven day period | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sedentary Behavior From Baseline to 12 Weeks | Minutes of total sedentary time measured over a seven day period | 12 weeks |
| Change in Autonomous Motivation From Baseline to 12 Weeks | We will measure feelings of autonomous and controlled motivation/regulation for physical activity |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | 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 | 12 weeks |
| Acceptability |
Inclusion Criteria:
1. Willing to be randomized to either group
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth J Lyons, PhD, MPH | The University of Texas Medical Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Medical Branch | Galveston | Texas | 77550 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31518281 | Derived | 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. | |
| 28264796 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Wait List Control | This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention. |
| FG001 | 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 Monitor intervention: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Wait List Control | This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention. |
| BG001 | Monitor Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Physical Activity From Baseline to 12 Weeks | Minutes of physical activity measured over a seven day period | Posted | Mean | Standard Deviation | minutes | 12 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wait List Control | This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stitches to hand | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eloisa Martinez | The University of Texas Medical Branch | 4092669643 | esmartin@utmb.edu |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D002318 | Cardiovascular Diseases |
| D009369 | Neoplasms |
| D003920 | Diabetes Mellitus |
| D055948 | Sarcopenia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 12 weeks |
| Change in Physical Fitness From Baseline to 12 Weeks | We will use the six minute walk test to measure physical fitness | 12 weeks |
| 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 | 12 weeks |
| Change in Physical Function From Baseline to 12 Weeks | Functional measurements will be made using the Senior Fitness Test | 12 weeks |
| Change in Weight From Baseline to 12 Weeks | We will measure weight (and height at baseline) using a calibrated scale | 12 weeks |
Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability
| 12 weeks |
This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls
Monitor intervention: 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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Sedentary Behavior From Baseline to 12 Weeks | Minutes of total sedentary time measured over a seven day period | Not Posted | 12 weeks | Participants |
| Secondary | Change in Autonomous Motivation From Baseline to 12 Weeks | We will measure feelings of autonomous and controlled motivation/regulation for physical activity | Not Posted | 12 weeks | Participants |
| Secondary | Change in Physical Fitness From Baseline to 12 Weeks | We will use the six minute walk test to measure physical fitness | Not Posted | 12 weeks | Participants |
| Secondary | 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 | Not Posted | 12 weeks | Participants |
| Secondary | Change in Physical Function From Baseline to 12 Weeks | Functional measurements will be made using the Senior Fitness Test | Not Posted | 12 weeks | Participants |
| Secondary | Change in Weight From Baseline to 12 Weeks | We will measure weight (and height at baseline) using a calibrated scale | Not Posted | 12 weeks | Participants |
| Other Pre-specified | Feasibility | 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 | Not Posted | 12 weeks | Participants |
| Other Pre-specified | Acceptability | Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability | Not Posted | 12 weeks | Participants |
| 0 |
| 40 |
| 0 |
| 40 |
| 2 |
| 40 |
| EG001 | 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 Monitor intervention: 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. | 0 | 40 | 0 | 40 | 3 | 40 |
| Nerve damage during blood draw | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Weakness | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Bone spur | General disorders | Systematic Assessment |
|
| Retinal detachment | Eye disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D001519 | Behavior |