Clinical trial NCT02878486: Intervention to Reduce Sedentary Time
Official title: Intervention to Reduce Sitting Time in Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Physical activity
Alzheimer's disease
cognitive impairment
sedentary behavior
insulin sensitivity
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Average Daily Sitting Time
timeFrame: Change from Baseline to Week 6
Secondary outcomes:
measure: Change in Average Daily Sitting Time
timeFrame: Change from Baseline to Week 12
measure: Number of Sitting Bouts Greater Than 30 Min
timeFrame: Week 12
measure: Change in Glucose Levels Area Under the Curve in Response to Mixed Meal Tolerance Test
timeFrame: Change from Baseline to Week 12
measure: Change in Insulin Levels Area Under the Curve Based on a Mixed Meal Tolerance Test
timeFrame: Change from Baseline to Week 12
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas
name: Amber Watts, PhD
role: PRINCIPAL_INVESTIGATOR
References: