Clinical Trials Directory

Trials / Completed

CompletedNCT02878486

Intervention to Reduce Sedentary Time

Intervention to Reduce Sitting Time in Mild Cognitive Impairment

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
University of Kansas Medical Center · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEJawbone UpJawbone Up is a wrist wore water resistant activity monitor.
BEHAVIORALPhysical Activity EducationA study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
DEVICEActivPALDevices 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).

Timeline

Start date
2016-08-01
Primary completion
2018-01-01
Completion
2018-01-01
First posted
2016-08-25
Last updated
2019-07-29
Results posted
2019-07-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02878486. Inclusion in this directory is not an endorsement.