Ecological Momentary Determinants of Sedentary Behavior

Sedentary Behavior Clinical Trial

Official title:

TranSITion: Ecological Momentary Determinants of Sedentary Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399916
• Other study ID #: STUDY00004349
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: February 2017

Study information

• Verified date: October 2019
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sedentary Behavior

Intervention

Behavioral:
• Prompt sent

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	American College of Sports Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minutes of sitting behavior (minutes/8h workday)	Objectively measured minutes of sitting, standardized to an 8h workday.	40 days
Primary	Minutes of standing behavior (minutes/8h workday)	Objectively measured minutes of standing, standardized to an 8h workday.	40 days
Primary	Minutes of light-intensity physical activity (minutes/8h workday)	Objectively measured minutes of light-intensity physical activity, standardized to an 8h workday.	40 days
Primary	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	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