Intervention to Reduce Sedentary Time

Mild Cognitive Impairment Clinical Trial

— ReST-MCI  

Official title:

Intervention to Reduce Sitting Time in Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02878486
• Other study ID #: STUDY00003981
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: January 2018

Study information

• Verified date: July 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• Jawbone Up
Jawbone Up is a wrist wore water resistant activity monitor.

Behavioral:
• Physical Activity Education
A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.

Device:
• 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).

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Change from Baseline to Week 6
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	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	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).	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).	Change from Baseline to Week 12