Intervention to Reduce Sedentary Time (ReST-MCI)

University of Kansas

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Device: ActivPAL; Device: Jawbone Up; Behavioral: Physical Activity Education

Study type: Interventional

Funder types: Other

Identifiers

NCT02878486

STUDY00003981

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Group 1

Experimental group

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.

Treatment:

Device: ActivPAL

Behavioral: Physical Activity Education

Device: Jawbone Up

Group 2

Active Comparator group

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.

Treatment:

Device: ActivPAL

Behavioral: Physical Activity Education