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The purpose of this study is to determine whether the researchers can help people change the amount of time they spend in sitting activities and whether this change might improve health outcomes.
Specific Aim 1: Determine feasibility of a 12-week home and telephone based intervention in older adults with mild cognitive impairment targeting both the impaired individual and their study partner to help initiate and maintain behavior change. We will recruit KUADC registry participants with MCI and their caregivers (as study partners). Behavioral interventions are more effective when there is built in social support. We will evaluate feasibility in terms of successful recruitment and retention of participants, 10% or less of technological failures, rate of participant concerns addressed by phone and at home visits, acceptability of the intervention to participants (measured by questionnaires during home visits).
Specific Aim 2: Determine whether a 12-week home and telephone based intervention results in reduced total sitting time and shorter bouts of sitting in older adults with MCI and their caregivers. Electronic postural monitors will record sitting time for a duration of one week at three time points (pre-intervention, mid-intervention, and post-intervention). The intervention includes 1) feedback from baseline monitoring, 2) educational and goal setting session with the participants and research staff, 3) wrist worn monitors that alert wearers to sitting times >30 minutes, 4) home and telephone visits to address physical, psychological, and home environment barriers to behavior change. Changes in sitting time and breaks from sitting will be compared between baseline, mid-intervention, and post-intervention measurement occasions.
Specific Aim 3: Determine whether sedentary behavior intervention results in improved insulin sensitivity and glycemic control. To evaluate whether reduced sitting results in meaningful metabolic changes, we will measure postprandial insulin and glucose, and body composition, and evaluate changes from pre- to post- intervention adjusting for relevant covariates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time. |
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| Group 2 | Active Comparator | Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jawbone Up | Device | Jawbone Up is a wrist wore water resistant activity monitor. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Daily Sitting Time | Average daily sitting time (minus sleep) at 6 weeks minus average daily sitting time (minus sleep) at baseline measured using the activPAL monitor | Change from Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Daily Sitting Time | Average daily sitting time (minus sleep) at 12 weeks minus average daily sitting time (minus sleep) at baseline measured using the ActivPAL monitor | Change from Baseline to Week 12 |
| Number of Sitting Bouts Greater Than 30 Min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amber Watts, PhD | University of Kansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group (Jawbone Up Wrist Monitor) | Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time. Jawbone Up: Jawbone Up is a wrist wore water resistant activity monitor. Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits. ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand). |
| FG001 | Control Group (No Wrist Monitor) | Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time. Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits. ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group (Jawbone Up Wrist Monitor) | Intervention group will have vibrotactile reminders from a wrist worn device, education about changing sitting habits, and coaching to change habits |
| BG001 | Control Group (No Wrist Monitor) |
| 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 Average Daily Sitting Time | Average daily sitting time (minus sleep) at 6 weeks minus average daily sitting time (minus sleep) at baseline measured using the activPAL monitor | Posted | Mean | Standard Deviation | minutes per day | Change from Baseline to Week 6 |
|
12 weeks
Note that only 3 of the 6 participants were tested with the mixed meal tolerance test and blood draws. Thus, only 3 were exposed to potential risks associated with these procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time. Jawbone Up: Jawbone Up is a wrist wore water resistant activity monitor. Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits. ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Rash at the site of adhesive used to attach monitoring device |
This is a very small sample and results are not generalizeable. It is a pilot study for feasibility only.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amber Watts, PhD | University of Kansas | 785-864-2604 | amberwatts@ku.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2016 | Apr 8, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D009043 | Motor Activity |
| D000544 | Alzheimer Disease |
| D057185 | Sedentary Behavior |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| Physical Activity Education |
| Behavioral |
A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits. |
|
| ActivPAL | Device | Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand). |
|
Change in the number of sitting bouts greater than 30 min measured using the ActivPAL monitor |
| Week 12 |
| Change in Glucose Levels Area Under the Curve in Response to Mixed Meal Tolerance Test | The average area under the curve at week 12 minus the average area under the curve at baseline. Blood was collected at baseline (pre-mixed meal). Post-mixed meal it was collected at 15, 30, 45, 60, 90, 120 minutes. The Area Under the Curve (AUC) was computed using the trapezoidal rule as we have previously described (Burns et. al. 2012, Morris et al 2014). This results in a single AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome measure (glucose, insulin, etc). The Area Under the Curve (AUC) for each individual is calculated as a single unitless value that results from calculating the definite integral under a timecourse curve. This method has been widely used and cited in metabolic studies for more than two decades https://doi.org/10.2337/diacare.17.2.152. This results in a single unitless AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome response measure (glucose, insulin, etc). | Change from Baseline to Week 12 |
| Change in Insulin Levels Area Under the Curve Based on a Mixed Meal Tolerance Test | The average area under the curve at week 12 minus the average area under the curve at baseline. Blood was collected at baseline (pre-mixed meal). Post-mixed meal it was collected at 15, 30, 45, 60, 90, 120 minutes. The Area Under the Curve (AUC) was computed using the trapezoidal rule as we have previously described (Burns et. al. 2012, Morris et al 2014). This results in a single AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome measure (glucose, insulin, etc). The Area Under the Curve (AUC) for each individual is calculated as a single unitless value that results from calculating the definite integral under a timecourse curve. This method has been widely used and cited in metabolic studies for more than two decades https://doi.org/10.2337/diacare.17.2.152. This results in a single unitless AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome response measure (glucose, insulin, etc). | Change from Baseline to Week 12 |
Control group will have education about changing sitting habits, no coaching or vibrotactile reminders |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Control Group (No Wrist Monitor) | Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time. Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits. ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand). |
|
|
| Secondary | Change in Average Daily Sitting Time | Average daily sitting time (minus sleep) at 12 weeks minus average daily sitting time (minus sleep) at baseline measured using the ActivPAL monitor | Posted | Mean | Standard Deviation | minutes per day | Change from Baseline to Week 12 |
|
|
|
| Secondary | Number of Sitting Bouts Greater Than 30 Min | Change in the number of sitting bouts greater than 30 min measured using the ActivPAL monitor | Posted | Mean | Standard Deviation | sitting bouts | Week 12 |
|
|
|
| Secondary | Change in Glucose Levels Area Under the Curve in Response to Mixed Meal Tolerance Test | The average area under the curve at week 12 minus the average area under the curve at baseline. Blood was collected at baseline (pre-mixed meal). Post-mixed meal it was collected at 15, 30, 45, 60, 90, 120 minutes. The Area Under the Curve (AUC) was computed using the trapezoidal rule as we have previously described (Burns et. al. 2012, Morris et al 2014). This results in a single AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome measure (glucose, insulin, etc). The Area Under the Curve (AUC) for each individual is calculated as a single unitless value that results from calculating the definite integral under a timecourse curve. This method has been widely used and cited in metabolic studies for more than two decades https://doi.org/10.2337/diacare.17.2.152. This results in a single unitless AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome response measure (glucose, insulin, etc). | Only three participants had data available for the mixed meal tolerance test | Posted | Mean | Standard Deviation | unitless | Change from Baseline to Week 12 |
|
|
|
| Secondary | Change in Insulin Levels Area Under the Curve Based on a Mixed Meal Tolerance Test | The average area under the curve at week 12 minus the average area under the curve at baseline. Blood was collected at baseline (pre-mixed meal). Post-mixed meal it was collected at 15, 30, 45, 60, 90, 120 minutes. The Area Under the Curve (AUC) was computed using the trapezoidal rule as we have previously described (Burns et. al. 2012, Morris et al 2014). This results in a single AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome measure (glucose, insulin, etc). The Area Under the Curve (AUC) for each individual is calculated as a single unitless value that results from calculating the definite integral under a timecourse curve. This method has been widely used and cited in metabolic studies for more than two decades https://doi.org/10.2337/diacare.17.2.152. This results in a single unitless AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome response measure (glucose, insulin, etc). | Only three participants had data available for the mixed meal tolerance test | Posted | Mean | Standard Deviation | unitless | Change from Baseline to Week 12 |
|
|
|
| Post-Hoc | Change in HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) | HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) is calculated as fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. The average HOMA-IR at week 12 minus the average HOMA-IR at baseline. A lower score means a person is more sensitive to insulin, whereas a higher score indicates greater resistance to insulin. The HOMA-IR is a tool for calculating degree of insulin resistance. Given that this is a product of insulin and glucose values divided by a constant, there is no maximum score for this measure. The minimum score would be zero as neither insulin or glucose would drop below zero. | Only three participants had data available for the mixed meal tolerance test | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to week 12 |
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| 0 |
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | Group 2 | Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time. Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits. ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand). | 0 | 3 | 0 | 3 | 1 | 3 |
|
| IV site irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | skin irritation at the site of IV used for blood collection |
|
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| D003704 |
| Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |