Movement-Oriented Behavioral Activation (MOBA)

NCT04892147 | Completed Results

• 2 other identifiers: Pro001080205P30AG064201
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Behavior

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Change in Behavioral Activation as Measured by the Behavioral Activation for Depression Scale (Short Form, BADS-SF).

  Baseline, 10 weeks

• Change in Self-Reported Sedentary Time on the Past-day Adults' Sedentary Time Questionnaire (PAST)

  Baseline, 10 weeks

• Change in Self-Reported Minutes of Moderate-to-Vigorous Physical Activity (MVPA)

  Baseline, 10 weeks

• Change in Perceived Barriers to Activity

  Baseline, 10 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Randomly selected to participate first in MOBA group

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

Behavioral: Mobility-Oriented Behavioral Activation

Interventions

Mobility-Oriented Behavioral Activation BEHAVIORAL

12-weeks of mobility-oriented behavioral activation group

Experimental group; Wait-list-control group

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Guy G. Potter, PhD
• Organization: Duke University

guy.potter@duke.edu

919-668-1269

Study Officials

• Guy Potter, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Wait-list control

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 19, 2021
• Study Start: December 14, 2021
• Primary Completion: July 20, 2022
• Study Completion: January 10, 2023
• Last Updated: December 12, 2023
• Results First Posted: December 12, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)