NCT03399916

Brief Summary

A two phase trial to understand the personal, behavioral, environmental, and contextual factors that underpin sedentary behavior and to systematically test a series of contextual prompt characteristics that may lead to subsequent change in sedentary behavior.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

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

October 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
Last Updated

October 31, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

December 22, 2017

Last Update Submit

October 29, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • Minutes of sitting behavior (minutes/8h workday)

    Objectively measured minutes of sitting, standardized to an 8h workday.

    40 days

  • Minutes of standing behavior (minutes/8h workday)

    Objectively measured minutes of standing, standardized to an 8h workday.

    40 days

  • Minutes of light-intensity physical activity (minutes/8h workday)

    Objectively measured minutes of light-intensity physical activity, standardized to an 8h workday.

    40 days

  • Minutes of moderate-vigorous physical activity (minutes/8h workday)

    Objectively measured minutes of moderate-vigorous physical activity, standardized to an 8h workday.

    40 days

Secondary Outcomes (1)

  • Momentary affective state (4-item Likert Scales)

    20 days

Study Arms (2)

Prompt

EXPERIMENTAL

An email based prompt was sent- containing either a stand or move message. Exploratory variations of the prompt were designed to include the addition of a goal e.g., stand for the next 5-minutes, and/or employer support e.g., PTS says "stand for the next 5 minutes".

Behavioral: Prompt sent

No Prompt

NO INTERVENTION

Prompt delivery was sequentially randomized to be sent (ST) or not sent (NST) to all participants (probability of 0.5), at eight decision points per day (between 9am and 5pm), to achieve a total of 3200 randomizations across participants (160 per participant). Therefore 50% of the time, no prompt was sent.

Interventions

Prompt sentBEHAVIORAL
Prompt

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Full-time employees
  • Males or females
  • Ages 18-65
  • Sedentary working habits (as indicated by \>7 hrs/day of sedentary time at work in the Sedentary Behavior Questionnaire)
  • Willing to engage in the study assessment and intervention for 10 weeks.

You may not qualify if:

  • Non-ambulatory, pregnant
  • Non-English speaking
  • Diagnosis of psychiatric problems or taking psychiatric medications
  • Medical history that prohibits prolonged standing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: PART B: A three-factor design with two-levels yielded eight experimental conditions, half of which encouraged standing more (stand; n prompt types = 80, n total prompts =800) and the other half encouraged moving more (move; n prompt types = 80, n total prompts =800).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 22, 2017

First Posted

January 17, 2018

Study Start

October 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

October 31, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations