Ecological Momentary Determinants of Sedentary Behavior

TranSITion: Ecological Momentary Determinants of Sedentary Behavior

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.

Study Overview

• Status: Completed
• Conditions: Sedentary Behavior
• Intervention / Treatment: Behavioral: Prompt sent

Detailed Description

Phase 1: This is an observational study that will utilized Ecological Momentary Assessment, to determine which personal (e.g. fatigue, mood, and stress level), behavioral (e.g. watching TV, working at desk, and eating meals), environmental (e.g. being at home or work, time of the day, and weather) and contextual factors were associated with sedentary behavior. Three EMAs per day will be sent randomly sent to participants on weekdays (Monday to Friday), for four consecutive weeks (total of 20 days). During these days, participants will also wear an activPAL device to objectively measure sedentary behavior. The purpose of the study is to identify the combination of factors most likely to precede and proceed short (<30 min) and long (≥30 min) bouts of sedentary behavior.

Phase 2: A micro-randomized trial will be used to evaluate the efficacy of an email-based prompt to elicit a proximal effect (e.g., a postural response defined as a transition from seated to standing or seated to moving within 5 minutes to interrupt prolonged sitting) compared to a no prompt condition. A secondary aim of this study is to determine whether prompts that encourage standing are more likely to elicit a response than those that encourage moving. An exploratory aim is to examine whether varying the content of the stand or move prompt to include combinations of short term goals and employer approval, influence the magnitude of response.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prompt; 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 Intervention: No Prompt; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Momentary affective state (4-item Likert Scales)	Affective states will be assessed using an ecological momentary survey based on the Positive and Negative Affect Scale (4-point Likert scale ranging from "not at all" to "extremely") (Range: 1-4) questionnaire. The ecological momentary assessment questions were designed to assess a range of contextual information (i.e., current office location, posture, social interaction) and physical and emotional feeling states (i.e., calmness, energy, happiness, stress, sadness, pain level, productivity, and willingness to stand/move). Each of these questions will be evaluated individually andaveraged to evaluate positive (i.e., calmness, energy, happiness) and negative (i.e., sadness and stress) affective states. An open-source app (Personal Analytic Companion App) will be used to deliver EMA questions randomly throughout a participant's workday. This will allow us to measure self-reported levels of positive or negative affect.	20 days

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: American College of Sports Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: December 22, 2017
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00004349

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No