Movement-Oriented Behavioral Activation (MOBA)

Sedentary Behavior Clinical Trial

Official title:

Movement-Oriented Behavioral Activation (MOBA) to Reduce Stationary Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04892147
• Other study ID #: Pro00108020
• Secondary ID: 5P30AG064201
• Status: Completed
• Phase: N/A
• Start date: December 14, 2021
• Est. completion date: January 10, 2023

Study information

• Verified date: November 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 10, 2023
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 64 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Sedentary Behavior

Intervention

Behavioral:
• Mobility-Oriented Behavioral Activation
12-weeks of mobility-oriented behavioral activation group

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 10 for the immediate intervention group, and Week 20 for the wait-list control group
Primary	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).	Baseline, 10 weeks
Primary	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).	Baseline, 10 weeks
Secondary	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).	Baseline, 10 weeks
Secondary	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).	Baseline, 10 weeks
Secondary	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).	Baseline, 10 weeks
Secondary	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.	Baseline, 10 weeks