Laboratory Model for Relapse to Sedentary Behavior

NCT04161040 | Completed

• 1 other identifier: 1810337844
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Physical inactivity is a key risk factor for noncommunicable illnesses such as cancer and cardiovascular disease-the two leading causes of death in West Virginia. The World Health Organization recommends muscle-strengthening activities 2 or more days per week and a minimum of either 150 minutes of moderate-intensity activity or 75 minutes of vigorous-intensity activity per week. Yet, only one in five adults in the United States meets these recommendations. Even more alarming is that 33.2% of West Virginians report that they did not engage in any physical activity in the past month. Incentive-based interventions increase physical activity in the short term, but incentives for healthy behavior are generally discontinued after some period of time, and relapse of unhealthy behavior is common. Thus, there is a critical need to develop interventions that result in both immediate and lasting engagement in activity. The overall objective and specific aim of the proposed project is to evaluate a brief laboratory model of relapse into sedentary behavior following incentive-based interventions that is based on Behavioral Momentum Theory. The central hypothesis is that incentives will increase activity, but relapse will occur in the brief model, like what occurs in extended clinical treatment. Development of a laboratory model of relapse into sedentary behavior (the expected outcome of the proposed project) will inform future translational research, eventually leading to clinical applications of large-scale physical-activity interventions that result in significant and immediate behavior change and that minimize relapse.

Conditions

Exercise

Keywords

Relapse; Physical Activity; Sedentary Behavior; Behavioral Momentum Theory; Incentives

Outcome Measures

Primary Outcomes (4)

• Minutes spent engaging in physical activity during each phase

  Trained research assistants will use software to score time-stamped duration of engagement in physical activity (defined as walking or running on the treadmill).

  Participants are in the lab for one 1-hour session. These observational data will be recorded continuously (every second) during the 1-Hour session.

• Minutes spent engaging in sedentary activity during each phase

  Trained research assistants will use software to score time-stamped duration of engagement in sedentary activity (defined as sitting or standing).

  Participants are in the lab for one 1-hour session. These observational data will be recorded continuously (every second) during the 1-Hour session.

• Average heart rate for each phase

  The heart rate monitor will sample and record heart rate on a second-by-second basis. The average heart rate will be calculated for each phase.

  Participants are in the lab for one 1-hour session. The polar heart rate monitor will be worn at all times during the session and the device samples heart rate at least one time per second during the 1-Hour session.

• Real-time record of heart rate

  The heart rate monitor will sample and record heart rate on a second-by-second basis and produce a time-stamped record that can be graphed and analyzed as time-series data.

  Participants are in the lab for one 1-hour session. The polar heart rate monitor will be worn at all times during the session and the device samples heart rate at least one time per second during the 1-Hour session.

Secondary Outcomes (4)

• Real-time record of activity zone

  Participants are in the lab for one 1-hour session. The polar heart rate monitor will be worn at all times during the session and the device samples heart rate at least one time per second during the 1-Hour session.

• Average number of minutes in each activity zone during each phase

  Participants are in the lab for one 1-hour session. The polar heart rate monitor will be worn at all times during the session and the device samples heart rate at least one time per second during the 1-Hour session.

• Systolic and Diastolic Blood Pressure reading

  Screening session and during the 1-hour session.

• Duration of time spend engaging in each activity type.

  Participants are in the lab for one 1-hour session. These observational data will be recorded continuously (every second) during the 1-Hour session.

Study Arms (3)

Relapse (experimental) Group

EXPERIMENTAL

Opportunities for sedentary leisure and physical activities will be continuously available throughout all phases. Each phase will last 20 minutes. The first phase will mimic pre-intervention conditions; there will be a variety of activities available. No incentives for engaging in physical activity will be provided, although such activities will be available. For the Relapse (experimental) Group, the second phase will mimic an incentive-based intervention in which participants can earn monetary incentives for engaging in physical activity. Then, during the third phase, the incentives will be discontinued.

Behavioral: Performance-based incentives

Fatigue Control Group

EXPERIMENTAL

Opportunities for sedentary leisure and physical activities will be continuously available throughout all phases. Each phase will last 20 minutes. The first phase will mimic pre-intervention conditions; there will be a variety of activities available. No incentives for engaging in physical activity will be provided, although such activities will be available. The second phase will mimic an incentive-based intervention in which participants can earn monetary incentives for engaging in physical activity. Participants in this arm will continue to earn incentives during Phase 3 to control reductions in physical activity due to fatigue.

Behavioral: Performance-based incentives

No-Incentive Control Group

NO INTERVENTION

Opportunities for sedentary leisure and physical activities will be continuously available throughout all phases. Each phase will last 20 minutes. Participants in this arm will not earn incentives during any of the three phases to control for the possibility that participants will engage in some physical activity in the absence of incentives.

Interventions

Performance-based incentives BEHAVIORAL

Participants will earn $1 per minute of engagement in physical activity.

Fatigue Control Group; Relapse (experimental) Group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• During the pre-screening session, eligibility will be assessed with the Physical Activity Readiness Questionnaire for Everyone (2011) and the individual's blood pressure reading. Individuals will not be eligible to participate if any of the following occur:
• The participant responds that they are or may be pregnant.
• The participant responds "Yes" to any question on the Physical Activity Readiness Questionnaire for Everyone with the exception of reporting a mental health condition (e.g., anxiety, depression, attention-deficit hyperactivity disorder) that is well controlled by medication and/or other therapies.
• The participant's blood pressure is 160 mm Hg or higher systolic or 90 mm Hg or higher diastolic.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Motor Activity; Recurrence; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathryn M Kestner, PhD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will not be told which group they have been assigned to.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Block randomization will be used to assign participants to one of three groups (one experimental and two control groups). All groups will experience three phases of the study. Opportunities for sedentary leisure and physical activities will be continuously available throughout all phases.

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 13, 2019
• Study Start: December 9, 2019
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication for at least 5 years.
• Access Criteria: Anyone interested in accessing the data.

Locations

US (1)