search
Back to results

Intervention to Reduce Sedentary Time (ReST-MCI)

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Jawbone Up
Physical Activity Education
ActivPAL
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Physical activity, Alzheimer's disease, cognitive impairment, sedentary behavior, insulin sensitivity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Number of Sitting Bouts Greater Than 30 Min
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
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
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).

Full Information

First Posted
August 22, 2016
Last Updated
July 26, 2019
Sponsor
University of Kansas Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02878486
Brief Title
Intervention to Reduce Sedentary Time
Acronym
ReST-MCI
Official Title
Intervention to Reduce Sitting Time in Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Physical activity, Alzheimer's disease, cognitive impairment, sedentary behavior, insulin sensitivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Jawbone Up
Intervention Description
Jawbone Up is a wrist wore water resistant activity monitor.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Education
Intervention Description
A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
Intervention Type
Device
Intervention Name(s)
ActivPAL
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Average Daily Sitting Time
Description
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
Secondary Outcome Measure Information:
Title
Change in Average Daily Sitting Time
Description
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
Title
Number of Sitting Bouts Greater Than 30 Min
Description
Change in the number of sitting bouts greater than 30 min measured using the ActivPAL monitor
Time Frame
Week 12
Title
Change in Glucose Levels Area Under the Curve in Response to Mixed Meal Tolerance Test
Description
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
Title
Change in Insulin Levels Area Under the Curve Based on a Mixed Meal Tolerance Test
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amber Watts, PhD
Organizational Affiliation
University of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intervention to Reduce Sedentary Time

We'll reach out to this number within 24 hrs