NCT02878486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 29, 2019

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

August 22, 2016

Results QC Date

April 8, 2019

Last Update Submit

July 26, 2019

Conditions

Mild Cognitive Impairment

Keywords

Physical activityAlzheimer's diseasecognitive impairmentsedentary behaviorinsulin sensitivity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in Average Daily Sitting Time

    Change from Baseline to Week 12

  • Number of Sitting Bouts Greater Than 30 Min

    Week 12

  • Change in Glucose Levels Area Under the Curve in Response to Mixed Meal Tolerance Test

    Change from Baseline to Week 12

  • Change in Insulin Levels Area Under the Curve Based on a Mixed Meal Tolerance Test

    Change from Baseline to Week 12

Study Arms (2)

Group 1

EXPERIMENTAL

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.

Device: Jawbone UpBehavioral: Physical Activity EducationDevice: ActivPAL

Group 2

ACTIVE COMPARATOR

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.

Behavioral: Physical Activity EducationDevice: ActivPAL

Interventions

Jawbone UpDEVICE

Jawbone Up is a wrist wore water resistant activity monitor.

Group 1
Physical Activity EducationBEHAVIORAL

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

Group 1Group 2
ActivPALDEVICE

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 1Group 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionMotor ActivityAlzheimer DiseaseSedentary BehaviorInsulin Resistance

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBehaviorDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Limitations and Caveats

This is a very small sample and results are not generalizeable. It is a pilot study for feasibility only.

Results Point of Contact

Title
Amber Watts, PhD
Organization
University of Kansas
amberwatts@ku.edu
785-864-2604

Study Officials

  • Amber Watts, PhD

    University of Kansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

August 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

July 29, 2019

Results First Posted

July 29, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)