Ecological Momentary Determinants of Sedentary Behavior

• ClinicalTrials.gov Identifier: NCT03399916
• Recruitment Status: Completed
• First Posted: January 17, 2018
• Last Update Posted: October 31, 2019
• Sponsor: Arizona State University
• Collaborator: American College of Sports Medicine
• Information provided by (Responsible Party): Matthew P Buman, PhD, Arizona State University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sedentary Behavior	Behavioral: Prompt sent	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: 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).
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: TranSITion: Ecological Momentary Determinants of Sedentary Behavior
• Actual Study Start Date: October 2016
• Actual Primary Completion Date: February 2017
• Actual Study Completion Date: February 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Minutes of sitting behavior (minutes/8h workday) [ Time Frame: 40 days ]
   Objectively measured minutes of sitting, standardized to an 8h workday.
2. Minutes of standing behavior (minutes/8h workday) [ Time Frame: 40 days ]
   Objectively measured minutes of standing, standardized to an 8h workday.
3. Minutes of light-intensity physical activity (minutes/8h workday) [ Time Frame: 40 days ]
   Objectively measured minutes of light-intensity physical activity, standardized to an 8h workday.
4. Minutes of moderate-vigorous physical activity (minutes/8h workday) [ Time Frame: 40 days ]
   Objectively measured minutes of moderate-vigorous physical activity, standardized to an 8h workday.

Secondary Outcome Measures :

1. Momentary affective state (4-item Likert Scales) [ Time Frame: 20 days ]
   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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Arizona

Arizona State University

Phoenix, Arizona, United States, 85004

Sponsors and Collaborators

Arizona State University

American College of Sports Medicine

  Study Documents (Full-Text)

Documents provided by Matthew P Buman, PhD, Arizona State University:

Study Protocol  [PDF] December 21, 2017

Statistical Analysis Plan  [PDF] December 21, 2017

More Information

• Responsible Party: Matthew P Buman, PhD, Associate Professor, Arizona State University
• ClinicalTrials.gov Identifier: NCT03399916
• Other Study ID Numbers: STUDY00004349
• First Posted: January 17, 2018
• Last Update Posted: October 31, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No