NCT02146001

Brief Summary

This study is a randomized trial that will compare the effects of two, 12-week activity interventions on patterns of physical activity, physical health, and quality of life measures in 40 older adults who are able to walk for exercise. One intervention will target 150 minutes per week of home-based moderate exercise (e.g. brisk walking), consistent with current recommendations. The other intervention will target a decrease in time spent in sedentary behaviors (e.g. sitting) of 60 minutes per day. Both interventions will wear an activity armband which will allow them to self-monitor their activity or sedentary behavior in real time using a smartphone. The armband will also provide objective data to an interventionist that will facilitate the intervention. The main outcome will be time spent in moderate exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 19, 2016

Completed
Last Updated

August 19, 2016

Status Verified

July 1, 2016

Enrollment Period

10 months

First QC Date

March 3, 2014

Results QC Date

April 20, 2016

Last Update Submit

July 9, 2016

Conditions

Keywords

sedentary behaviorphysical activityolder adults

Outcome Measures

Primary Outcomes (1)

  • Change in Objectively Monitored Sedentary Behavior

    Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks. This multi-sensor armband will give an estimate of time spent in sedentary behavior over a 1 week period. Sedentary time will be averaged across days and reported as hours per day.

    Change from baseline to 12 weeks

Secondary Outcomes (2)

  • Change in Physical Function (Short Physical Performance Battery [SPPB])

    Change from baseline to 12 weeks

  • Change in Objectively-monitored Moderate-to-vigorous Physical Activity

    Change from baseline to 12 weeks

Study Arms (2)

Moderate-to-vigorous activity group

ACTIVE COMPARATOR

This group will target achieving the current recommendations for physical activity in older adults. This is 150 minutes of moderate-to-vigorous activity per week.

Other: Moderate-to-vigorous activity group

Reducing sedentary behavior group

EXPERIMENTAL

This group will target a 60 minute per day reduction in sedentary behavior using an objective activity monitor.

Other: Reducing sedentary behavior group

Interventions

This intervention will use individual counseling and the the BodyMedia armband to self-monitor sedentary behavior. The goal will be to decrease time spent in sedentary behavior by 60 minutes each day.

Reducing sedentary behavior group

This group will be administered an individual, behavioral intervention using the BodyMedia armband to self-monitor physical activity. The prescription will be 150 minutes of moderate exercise (e.g. brisk walking) each week.

Moderate-to-vigorous activity group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥60 years
  • Currently engage in \<60 minutes of MVPA per week
  • Ability to complete a 400 meter walk test without an assistive device
  • Access to a computer and compatible smartphone (Andriod or iPhone) for the use of the BodyMedia® Fit System to monitor Moderate -to - Vigorous physical activity or sedentary behavior
  • Ability to provide medical clearance to participate in this study from their primary care physician

You may not qualify if:

  • Unable to provide informed consent
  • Household member on study staff
  • Current or planned enrollment in another physical activity or weight loss program
  • Cardiovascular event (heart attack, stroke, heart failure, revascularization procedure) in the last 6 months
  • Current use of beta-blockers or other medication that could affect heart rate
  • Currently treated for psychological issues, or taking psychotropic medications within the previous 6 months
  • Comorbid condition that would limit participation in exercise (e.g. uncontrolled hypertension, severe arthritis, use of a assistive mobility device, currently undergoing treatment for cancer)
  • \>3 alcoholic beverages per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Activity and Weight Management Research Center

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Bethany Barone Gibbs
Organization
University of Pittsburgh

Study Officials

  • Bethany Barone Gibbs, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 3, 2014

First Posted

May 23, 2014

Study Start

January 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

August 19, 2016

Results First Posted

August 19, 2016

Record last verified: 2016-07

Locations