Clinical trial NCT04892147: Movement-Oriented Behavioral Activation (MOBA)
Official title: Movement-Oriented Behavioral Activation (MOBA) to Reduce Stationary Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2021-05-19
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Wait-list control
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of Movement-Oriented Behavioral Activation (MOBA)
timeFrame: Week 10 for the immediate intervention group, and Week 20 for the wait-list control group
measure: Change in Short Physical Performance Battery (SPPB)
timeFrame: Baseline, 10 weeks
measure: Change in Endurance as Measured by the 6-Minute Walk Test (6MWT)
timeFrame: Baseline, 10 weeks
Secondary outcomes:
measure: Change in Behavioral Activation as Measured by the Behavioral Activation for Depression Scale (Short Form, BADS-SF).
timeFrame: Baseline, 10 weeks
measure: Change in Self-Reported Sedentary Time on the Past-day Adults' Sedentary Time Questionnaire (PAST)
timeFrame: Baseline, 10 weeks
measure: Change in Self-Reported Minutes of Moderate-to-Vigorous Physical Activity (MVPA)
timeFrame: Baseline, 10 weeks
measure: Change in Perceived Barriers to Activity
timeFrame: Baseline, 10 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Guy Potter, PhD
role: PRINCIPAL_INVESTIGATOR
References: