NCT03412084

Brief Summary

The purpose of the expanded study is to examine the effectiveness of a "Stand Up and Move More" intervention to reduce sedentary behavior in older adults from underserved communities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

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

First Submitted

Initial submission to the registry

January 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 14, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 16, 2020

Completed
Last Updated

December 16, 2020

Status Verified

November 1, 2020

Enrollment Period

1.7 years

First QC Date

January 19, 2018

Results QC Date

November 18, 2020

Last Update Submit

November 18, 2020

Conditions

Keywords

Sedentary Lifestylephysical function

Outcome Measures

Primary Outcomes (1)

  • Total Sedentary Time Per Day

    Participants wore monitors during the day to assess total sitting time/day

    Baseline, 4 weeks, 12 weeks

Secondary Outcomes (1)

  • Short Physical Performance Battery (SPPB) Score

    Baseline, 4 weeks, 12 weeks

Study Arms (2)

Stand up intervention

EXPERIMENTAL

four week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting

Behavioral: Stand up and move more

Control

NO INTERVENTION

No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group

Interventions

4 week behavioral intervention involving the development and implementation of action plans

Stand up intervention

Eligibility Criteria

Age56 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults older than 55 yrs of age
  • inactive or low active (i.e., less than 60 minutes of physical activity/week)
  • residents of Dane, Iowa, Rock or Vilas counties, and
  • residing in a home or an apartment.

You may not qualify if:

  • low levels of sedentary behavior (less than or equal to 6 hours/day),
  • recent hospitalization (i.e., past month),
  • uncontrolled medical conditions including: uncontrolled hypertension, heart disease, actively receiving chemotherapy or palliative care for cancer, stage 4 liver disease, end-stage renal or pulmonary disease, severe arthritis or any other orthopedic condition that could be made worse by standing up and moving more;
  • inability to stand up without assistance of another person, and
  • inability to speak or hear spoken English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kelli Koltyn

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Kelli F Koltyn
Organization
University of Wisconsin - Madison

Study Officials

  • Kelli Koltyn, PhD

    UW-Madison

    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
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

January 26, 2018

Study Start

March 14, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 16, 2020

Results First Posted

December 16, 2020

Record last verified: 2020-11

Locations