Intervention to Reduce Sedentary Time

NCT ID: NCT02878486

Last Updated: 2019-07-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-01-31

Brief Summary

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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

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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

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

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.

Group Type EXPERIMENTAL

Jawbone Up

Intervention Type DEVICE

Jawbone Up is a wrist wore water resistant activity monitor.

Physical Activity Education

Intervention Type BEHAVIORAL

A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.

ActivPAL

Intervention Type DEVICE

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).

Group 2

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.

Group Type ACTIVE_COMPARATOR

Physical Activity Education

Intervention Type BEHAVIORAL

A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.

ActivPAL

Intervention Type DEVICE

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).

Interventions

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Jawbone Up

Jawbone Up is a wrist wore water resistant activity monitor.

Intervention Type DEVICE

Physical Activity Education

A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.

Intervention Type BEHAVIORAL

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).

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Amber Watts, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amber Watts, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STUDY00003981

Identifier Type: -

Identifier Source: org_study_id

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