Mild Cognitive ImpairmentReST-MCINCT02878486
Intervention to Reduce Sedentary Time
A study testing Jawbone Up, Physical Activity Education and ActivPAL in people with Mild Cognitive Impairment, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Jawbone Up, Physical Activity Education and ActivPAL
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Intervention to Reduce Sitting Time in Mild Cognitive Impairment
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Jawbone Up, Physical Activity Education, ActivPAL
- Keywords
- Physical activity, Alzheimer's disease, cognitive impairment, sedentary behavior, insulin sensitivity
- Medical subject headings
- Cognitive Dysfunction, Motor Activity, Alzheimer Disease, Sedentary Behavior, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jawbone UpDevice
Jawbone Up is a wrist wore water resistant activity monitor.
Physical Activity EducationBehavioural
A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPALDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Jawbone Up; Behavioral: Physical Activity Education; Device: ActivPAL |
| 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. Receives: Behavioral: Physical Activity Education; Device: ActivPAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline to Week 6
Secondary outcomes (4)
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
Measured: Change from Baseline to Week 12
Number of Sitting Bouts Greater Than 30 Min
Change in the number of sitting bouts greater than 30 min measured using the ActivPAL monitor
Measured: 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).
Measured: 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).
Measured: Change from Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amber Watts, PhD, University of Kansas
- Investigators
- Amber Watts, PhD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878486
- Sponsor's protocol ID
- STUDY00003981
- Acronym
- ReST-MCI
- Status last verified
- Jul 2019
- First submitted
- 22 Aug 2016
- Last updated
- 29 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Reduce Sitting Time in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT02878486
- Acronym / sponsor ID
- ReST-MCI / STUDY00003981
- Conditions
- Mild Cognitive Impairment
- Keywords
- Physical activity, Alzheimer's disease, cognitive impairment, sedentary behavior, insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Posted 29 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Jawbone Up, Behavioral: Physical Activity Education, Device: ActivPALSubjects 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. |
| Group 2 | Active comparator | Behavioral: Physical Activity Education, Device: ActivPALSubjects 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jawbone UpJawbone Up is a wrist wore water resistant activity monitor. | Device | Group 1 |
| Physical Activity EducationA study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits. | Behavioural | Group 1, Group 2 |
| ActivPALDevices 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). | Device | Group 1, Group 2 |
Primary outcome
Change in Average Daily Sitting Time
Time frame: 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
4 secondary outcomes
Change in Average Daily Sitting Time
Time frame: Change from Baseline to Week 12
Number of Sitting Bouts Greater Than 30 Min
Time frame: Week 12
Change in Glucose Levels Area Under the Curve in Response to Mixed Meal Tolerance Test
Time frame: Change from Baseline to Week 12
Change in Insulin Levels Area Under the Curve Based on a Mixed Meal Tolerance Test
Time frame: Change from Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amber Watts, PhD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jawbone Up, Physical Activity Education and ActivPAL in people with Mild Cognitive Impairment, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Average Daily Sitting Time (time frame: Change from Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.