Sedentary BehaviorNCT04892147
Movement-Oriented Behavioral Activation (MOBA)
A study testing Mobility-Oriented Behavioral Activation in people with Sedentary Behavior, run by Duke University at 1 site in United States.
Trial summary
The purpose of this research study is to determine the acceptability, feasibility, and effectiveness of behavioral activation to increase everyday movement and reduce the amount of time spent daily in positions of prolonged standing and sitting. This intervention is call Movement-Oriented Behavioral Activation (MOBA). Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Mobility-Oriented Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2021to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pilot cohort will be composed of food service workers drawn employee by sponsor's organization. The age range was chosen to target the critical window for establishing the long-term geroprotective benefits of increasing movement-oriented behaviors. The workplace cohort was chosen because their work demands are characterized by a high level of stationary activity.
Who cannot join
- 1) individuals with moderate or greater depression severity (PHQ-9 > 14); and 2) individuals with significant mobility limitation, defined as inability to complete 6 Minute-Walk Test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27701
About this study
Official title: Movement-Oriented Behavioral Activation (MOBA) to Reduce Stationary Behavior
The purpose of this research study is to determine the acceptability, feasibility, and effectiveness of behavioral activation to increase everyday movement and reduce the amount of time spent daily in positions of prolonged standing and sitting. This intervention is call Movement-Oriented Behavioral Activation (MOBA). Participants will undergo a 60-minute screening that includes health and lifestyle questionnaires, mobility testing and a six-minute walk. Participants will complete the same procedures after completing MOBA. Each participant will be randomly assigned to an intervention group or a wait-list group. Both groups will participate in the same 12-week MOBA group protocol, but the intervention group participates first. During MOBA sessions, participants will set movement goals to reduce total time spent sitting and standing, and learn exercises and strategies to get more physical activity throughout the day and evening. At the end of the 12-week group, all participants, including those on the wait-list will be asked to complete the same questionnaires, mobility testing, and 6-minute walk as the beginning of the study. Total study duration for the intervention group is about 4 months. Total study duration for wait-list group will be about 8 months, which about half of that time spent in the waiting period.
Separate from the intervention there will be a focus group with prospective participants (N = 4-8) to collect information about physical activity perspectives and experiences to better align delivery of the intervention to the target cohort (participation in the focus group does not obligate participation in the intervention). A focus group will be conducted post intervention also. Participants enrolled in the intervention can participate in the focus groups.
Read the detailed description
Overview. The study uses randomized waitlist-control design. We propose to randomly assign half of participants to (a) 10 weeks of MOBA intervention, and half of participants to (b) a 10-week waitlist, followed by 10 weeks of MOBA.
Intervention. MOBA is adapted from established protocols to integrate traditional behavioral activation (BA) principles with strategies to incorporate values-based, goal-directed movement into daily routines. The BA content of MOBA is adapted from co-investigator Dr. Smoski's intervention Behavioral Activation Therapy for Anhedonia (BATA). MOBA reduces depression-related content relative to BATA and increases focus on values that engage individuals in movement-related activity. MOBA is designed as a group intervention to leverage the reward value of social contact, and the positive influence of group problem-solving and accountability on behavior change. MOBA preserves the principles and general sequence of sessions used in BATA, but incorporates movement-oriented content: (a) provide psychoeducation about risks of physical inactivity, behavioral barriers to activity, and rationale for the treatment approach; (b) explore personal values, non-stationary, movement-oriented activities that support those values, and a hierarchical plan for goal attainment; (c) identify and assign weekly activities related to the valued goals; (d) address common barriers to engagement with valued activities including avoidance, low behavioral initiation, and an overemphasis on felt motivation as a prerequisite for action; and (e) monitor, support, and reward achieving behavioral goals. Content unique to MOBA includes: 1) demonstration and participation in physical activities that provide alternatives to stationary behavior, including select activities used in a previous study with the Dining Services cohort (e.g., stairs, body-weight squats, knee raises), and 2) generation of person-centered strategies for integrating movement-oriented activities into daily routines across the three domains of the Behavior Settings Model: 1) workplace sitting/prolonged standing, 2) screen-focused home activities, 3) time spent sitting in automobiles. Weeks 1-4 address topics a-c; weeks 5-12 address topics d-e. MOBA will be facilitated by a clinician (Dr. Potter) and a wellness educator (Dr. Tittle), who will be trained on the MOBA treatment manual. The facilitators' role is to provide teaching, support, encouragement, and guidance throughout the intervention. Weekly sessions will take place in a dedicated conference room near the workplace, during the last hour of the workday (4-5 pm), and is counted as paid time at work.
- Conditions
- Sedentary Behavior
- Being tested
- Mobility-Oriented Behavioral Activation
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobility-Oriented Behavioral ActivationBehavioural
12-weeks of mobility-oriented behavioral activation group
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Randomly selected to participate first in MOBA group Receives: Behavioral: Mobility-Oriented Behavioral Activation |
| Wait-list-control group | Other | Randomly selected for study assessments parallel with experimental group. Participates in MOBA after completion of the experimental group Receives: Behavioral: Mobility-Oriented Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Movement-Oriented Behavioral Activation (MOBA)
Survey questionnaire assessing participant experience of session content relevant to importance, competence achieved, enjoyment, activity change, group competition, and overall experience. Reported here is the mean response score on the Enjoyment scale, which surveyed 8 content topics on a 1-5 Likert scale, with higher values reflecting greater enjoyment (total range = 8-40). For the purposes of the analsyis, the mean of the Enjoyment scale was converted be comparable to original Likert scale range of 1-5, with a score of 3 characterizing the null hypotheis value of a "neutral" response.
Measured: Week 10 for the immediate intervention group, and Week 20 for the wait-list control group
Change in Short Physical Performance Battery (SPPB)
The SPPB is a validated assessment of physical performance across three tasks: balance, gait speed, and chair stand. Each task is rated on a scale of 0-4, with a total range of range 0-12. Higher scores reflect better performance. Change = (Week 10 Score - Baseline Score).
Measured: Baseline, 10 weeks
Change in Endurance as Measured by the 6-Minute Walk Test (6MWT)
6MWT is a validated measure of aerobic capacity/endurance as measured by the number of feet walked in six minutes following a specified route. A greater number of feet completed reflects greater aerobic capacity/endurance. Change = (Week 10 Score - Baseline Score).
Measured: Baseline, 10 weeks
Secondary outcomes (4)
Change in Behavioral Activation as Measured by the Behavioral Activation for Depression Scale (Short Form, BADS-SF).
The BADs-SF is a validated short from of the original BADS. Both measures are self-report questionnaires designed to measures the mechanism of activation. The BADS-SF is composed of 9 items rated on a 0 to 6 scale. The total score range is 0-54, with higher scores reflecting greater engagement with rewarding activities. Change = (Week 10 Score - Baseline Score).
Measured: Baseline, 10 weeks
Change in Self-Reported Sedentary Time on the Past-day Adults' Sedentary Time Questionnaire (PAST)
The Past-Day Adults' Sedentary Time questionnaire (PAST) is a validated questionnaire in which the participant estimates the is the hours spent sedentary across 7 domains of daily activity. The outcome variable was measured in total minutes converted to hours (minutes/60). Higher values represent more time spent sedentary. Change = (Week 10 Score - Baseline Score).
Measured: Baseline, 10 weeks
Change in Self-Reported Minutes of Moderate-to-Vigorous Physical Activity (MVPA)
Self-reported minutes per week of moderate-to-vigorous physical activity. Moderate activity was calculated from number of days per week reported moderate physical activity (0-7) multiplied by average minutes reported per day. Vigorous physical activity calculated in the same manner. The total MVPA score was the sum of moderate and vigorous minutes reported. Greater number of minutes reflects higher levels of physical activity. Change = (Week 10 Score - Baseline Score).
Measured: Baseline, 10 weeks
Change in Perceived Barriers to Activity
The Barriers to Being Active Quiz has a score range from 0-63, with higher scores reflecting greater perceived barriers to activity.
Measured: Baseline, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start14 Dec 2021
- Primary completion20 Jul 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Wait-list control
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Guy Potter, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892147
- Sponsor's protocol ID
- Pro00108020
- Other IDs
- 5P30AG064201
- Status last verified
- Nov 2023
- First submitted
- 13 May 2021
- Last updated
- 12 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement-Oriented Behavioral Activation (MOBA) to Reduce Stationary Behavior
- ClinicalTrials.gov ID
- NCT04892147
- Acronym / sponsor ID
- Pro00108020
- Conditions
- Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Posted 12 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine the acceptability, feasibility, and effectiveness of behavioral activation to increase everyday movement and reduce the amount of time spent daily in positions of prolonged standing and sitting. This intervention is call Movement-Oriented Behavioral Activation (MOBA). Participants will undergo a 60-minute screening that includes health and lifestyle questionnaires, mobility testing and a six-minute walk. Participants will complete the same procedures after completing MOBA. Each participant will be randomly assigned to an intervention group or a wait-list group. Both groups will participate in the same 12-week MOBA group protocol, but the intervention group participates first. During MOBA sessions, participants will set movement goals to reduce total time spent sitting and standing, and learn exercises and strategies to get more physical activity throughout the day and evening. At the end of the 12-week group, all participants, including those on the wait-list will be asked to complete the same questionnaires, mobility testing, and 6-minute walk as the beginning of the study. Total study duration for the intervention group is about 4 months. Total study duration for wait-list group will be about 8 months, which about half of that time spent in the waiting period.
Separate from the intervention there will be a focus group with prospective participants (N = 4-8) to collect information about physical activity perspectives and experiences to better align delivery of the intervention to the target cohort (participation in the focus group does not obligate participation in the intervention). A focus group will be conducted post intervention also. Participants enrolled in the intervention can participate in the focus groups.
Detailed description
Overview. The study uses randomized waitlist-control design. We propose to randomly assign half of participants to (a) 10 weeks of MOBA intervention, and half of participants to (b) a 10-week waitlist, followed by 10 weeks of MOBA.
Intervention. MOBA is adapted from established protocols to integrate traditional behavioral activation (BA) principles with strategies to incorporate values-based, goal-directed movement into daily routines. The BA content of MOBA is adapted from co-investigator Dr. Smoski's intervention Behavioral Activation Therapy for Anhedonia (BATA). MOBA reduces depression-related content relative to BATA and increases focus on values that engage individuals in movement-related activity. MOBA is designed as a group intervention to leverage the reward value of social contact, and the positive influence of group problem-solving and accountability on behavior change. MOBA preserves the principles and general sequence of sessions used in BATA, but incorporates movement-oriented content: (a) provide psychoeducation about risks of physical inactivity, behavioral barriers to activity, and rationale for the treatment approach; (b) explore personal values, non-stationary, movement-oriented activities that support those values, and a hierarchical plan for goal attainment; (c) identify and assign weekly activities related to the valued goals; (d) address common barriers to engagement with valued activities including avoidance, low behavioral initiation, and an overemphasis on felt motivation as a prerequisite for action; and (e) monitor, support, and reward achieving behavioral goals. Content unique to MOBA includes: 1) demonstration and participation in physical activities that provide alternatives to stationary behavior, including select activities used in a previous study with the Dining Services cohort (e.g., stairs, body-weight squats, knee raises), and 2) generation of person-centered strategies for integrating movement-oriented activities into daily routines across the three domains of the Behavior Settings Model: 1) workplace sitting/prolonged standing, 2) screen-focused home activities, 3) time spent sitting in automobiles. Weeks 1-4 address topics a-c; weeks 5-12 address topics d-e. MOBA will be facilitated by a clinician (Dr. Potter) and a wellness educator (Dr. Tittle), who will be trained on the MOBA treatment manual. The facilitators' role is to provide teaching, support, encouragement, and guidance throughout the intervention. Weekly sessions will take place in a dedicated conference room near the workplace, during the last hour of the workday (4-5 pm), and is counted as paid time at work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Wait-list control
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Mobility-Oriented Behavioral ActivationRandomly selected to participate first in MOBA group |
| Wait-list-control group | Other | Behavioral: Mobility-Oriented Behavioral ActivationRandomly selected for study assessments parallel with experimental group. Participates in MOBA after completion of the experimental group |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pilot cohort will be composed of food service workers drawn employee by sponsor's organization. The age range was chosen to target the critical window for establishing the long-term geroprotective benefits of increasing movement-oriented behaviors. The workplace cohort was chosen because their work demands are characterized by a high level of stationary activity.
Key exclusion criteria (1 listed)
- 1) individuals with moderate or greater depression severity (PHQ-9 > 14); and 2) individuals with significant mobility limitation, defined as inability to complete 6 Minute-Walk Test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobility-Oriented Behavioral Activation12-weeks of mobility-oriented behavioral activation group | Behavioural | Experimental group, Wait-list-control group |
Primary outcome
Acceptability of Movement-Oriented Behavioral Activation (MOBA)
Time frame: Week 10 for the immediate intervention group, and Week 20 for the wait-list control group
Survey questionnaire assessing participant experience of session content relevant to importance, competence achieved, enjoyment, activity change, group competition, and overall experience. Reported here is the mean response score on the Enjoyment scale, which surveyed 8 content topics on a 1-5 Likert scale, with higher values reflecting greater enjoyment (total range = 8-40). For the purposes of the analsyis, the mean of the Enjoyment scale was converted be comparable to original Likert scale range of 1-5, with a score of 3 characterizing the null hypotheis value of a "neutral" response.
Change in Short Physical Performance Battery (SPPB)
Time frame: Baseline, 10 weeks
The SPPB is a validated assessment of physical performance across three tasks: balance, gait speed, and chair stand. Each task is rated on a scale of 0-4, with a total range of range 0-12. Higher scores reflect better performance. Change = (Week 10 Score - Baseline Score).
Change in Endurance as Measured by the 6-Minute Walk Test (6MWT)
Time frame: Baseline, 10 weeks
6MWT is a validated measure of aerobic capacity/endurance as measured by the number of feet walked in six minutes following a specified route. A greater number of feet completed reflects greater aerobic capacity/endurance. Change = (Week 10 Score - Baseline Score).
4 secondary outcomes
Change in Behavioral Activation as Measured by the Behavioral Activation for Depression Scale (Short Form, BADS-SF).
Time frame: Baseline, 10 weeks
Change in Self-Reported Sedentary Time on the Past-day Adults' Sedentary Time Questionnaire (PAST)
Time frame: Baseline, 10 weeks
Change in Self-Reported Minutes of Moderate-to-Vigorous Physical Activity (MVPA)
Time frame: Baseline, 10 weeks
Change in Perceived Barriers to Activity
Time frame: Baseline, 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Potter, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobility-Oriented Behavioral Activation in people with Sedentary Behavior, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Movement-Oriented Behavioral Activation (MOBA) (time frame: Week 10 for the immediate intervention group, and Week 20 for the wait-list control group). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.