Mild Cognitive Impairment
Conditions
Keywords
Physical activity, Alzheimer's disease, cognitive impairment, sedentary behavior, insulin sensitivity
Brief summary
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.
Detailed description
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.
Interventions
DEVICEJawbone Up
Jawbone Up is a wrist wore water resistant activity monitor.
BEHAVIORALPhysical Activity Education
A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
DEVICEActivPAL
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).
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Enrolled in the University of Kansas (KU) Alzheimer's Disease Center (ADC) Registry * Clinical Dementia Rating (CDR) = 0.5 * Inactive status as determined by the Measure of Older Adults' Sedentary Time (MOST) questionnaire * Retired or \<20 hours/week in an office * Lives with partner in a community dwelling setting
Exclusion criteria
* Unable to stand or walk unassisted * Inadequate visual, auditory, or English language capacity * Adhesive allergy * Current uncontrolled Type 2 diabetes * Unwilling to change sitting behavior
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Daily Sitting Time | Change from Baseline to Week 6 | Average daily sitting time (minus sleep) at 6 weeks minus average daily sitting time (minus sleep) at baseline measured using the activPAL monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Daily Sitting Time | Change from Baseline to Week 12 | Average daily sitting time (minus sleep) at 12 weeks minus average daily sitting time (minus sleep) at baseline measured using the ActivPAL monitor |
| Number of Sitting Bouts Greater Than 30 Min | Week 12 | Change in the number of sitting bouts greater than 30 min measured using the ActivPAL monitor |
| Change in Glucose Levels Area Under the Curve in Response to Mixed Meal Tolerance Test | Change from Baseline to Week 12 | 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 in Insulin Levels Area Under the Curve Based on a Mixed Meal Tolerance Test | Change from Baseline to Week 12 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 3 |
| Control Group (No Wrist Monitor) Control group will have education about changing sitting habits, no coaching or vibrotactile reminders | 3 |
| Total | 6 |
Baseline characteristics
| Characteristic | Intervention Group (Jawbone Up Wrist Monitor) | Total | Control Group (No Wrist Monitor) |
|---|---|---|---|
| Age, Continuous | 81.33 years STANDARD_DEVIATION 8.62 | 81.08 years STANDARD_DEVIATION 6.42 | 80.83 years STANDARD_DEVIATION 5.35 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 3 Participants |
| Region of Enrollment United States | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 1 / 3 | 1 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
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
Time frame: Change from Baseline to Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Jawbone Up Wrist Monitor) | Change in Average Daily Sitting Time | 0.43 minutes per day | Standard Deviation 0.53 |
| Control Group (No Wrist Monitor) | Change in Average Daily Sitting Time | 0.98 minutes per day | Standard Deviation 1.82 |
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
Time frame: Change from Baseline to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Jawbone Up Wrist Monitor) | Change in Average Daily Sitting Time | -0.17 minutes per day | Standard Deviation 0.41 |
| Control Group (No Wrist Monitor) | Change in Average Daily Sitting Time | -0.24 minutes per day | Standard Deviation 0.56 |
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).
Time frame: Change from Baseline to Week 12
Population: Only three participants had data available for the mixed meal tolerance test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Jawbone Up Wrist Monitor) | Change in Glucose Levels Area Under the Curve in Response to Mixed Meal Tolerance Test | 178.88 unitless | Standard Deviation 2144.12 |
| Control Group (No Wrist Monitor) | Change in Glucose Levels Area Under the Curve in Response to Mixed Meal Tolerance Test | 1008.38 unitless | Standard Deviation 0 |
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).
Time frame: Change from Baseline to Week 12
Population: Only three participants had data available for the mixed meal tolerance test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Jawbone Up Wrist Monitor) | Change in Insulin Levels Area Under the Curve Based on a Mixed Meal Tolerance Test | 2623.43 unitless | Standard Deviation 1929.77 |
| Control Group (No Wrist Monitor) | Change in Insulin Levels Area Under the Curve Based on a Mixed Meal Tolerance Test | 1776.38 unitless | Standard Deviation 0 |
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
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Jawbone Up Wrist Monitor) | Number of Sitting Bouts Greater Than 30 Min | 1 sitting bouts | Standard Deviation 1.41 |
| Control Group (No Wrist Monitor) | Number of Sitting Bouts Greater Than 30 Min | .167 sitting bouts | Standard Deviation 0.764 |
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.
Time frame: Change from baseline to week 12
Population: Only three participants had data available for the mixed meal tolerance test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Jawbone Up Wrist Monitor) | Change in HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) | 96438.33 units on a scale | Standard Deviation 25698.46 |
| Control Group (No Wrist Monitor) | Change in HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) | 63383.80 units on a scale | Standard Deviation 0 |