Trial Outcomes & Findings for Movement-Oriented Behavioral Activation (MOBA) (NCT NCT04892147)

Last Updated: 2023-12-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

Week 10 for the immediate intervention group, and Week 20 for the wait-list control group

Results posted on

2023-12-12

Participant Flow

Pre-intervention focus group participants were not considered enrolled.

Participant milestones

Participant milestones
Measure	Experimental Group Randomly selected to participate first in MOBA group Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group	Wait-list-control Group Randomly selected for study assessments parallel with experimental group. Participates in MOBA after completion of the experimental group Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group
Overall Study STARTED	15	11
Overall Study COMPLETED	13	11
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Group Randomly selected to participate first in MOBA group Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group	Wait-list-control Group Randomly selected for study assessments parallel with experimental group. Participates in MOBA after completion of the experimental group Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Movement-Oriented Behavioral Activation (MOBA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Group n=13 Participants Randomly selected to participate first in MOBA group Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group	Wait-list-control Group n=11 Participants Randomly selected for study assessments parallel with experimental group. Participates in MOBA after completion of the experimental group Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group	Total n=24 Participants Total of all reporting groups
Age, Continuous	55.46 years STANDARD_DEVIATION 6.75 • n=5 Participants	55.27 years STANDARD_DEVIATION 8.36 • n=7 Participants	55.37 years STANDARD_DEVIATION 7.49 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 10 for the immediate intervention group, and Week 20 for the wait-list control group

Population: Participants from both groups who completed the questionnaire after their respective participation in the MOBA intervention. The a priori statistical plan was to examine acceptability ratings at end of intervention, which includes combining these data from both the experimental and waitlist groups for the reported analysis.

Outcome measures

Outcome measures
Measure	Combined Experimental Group n=22 Participants Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group	Wait-list-control Group Randomly selected for study assessments parallel with experimental group. Participates in MOBA after completion of the experimental group Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group
Acceptability of Movement-Oriented Behavioral Activation (MOBA)	4.7 score on a scale Standard Deviation 0.4	—

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Combined Experimental Group n=13 Participants Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group	Wait-list-control Group n=11 Participants Randomly selected for study assessments parallel with experimental group. Participates in MOBA after completion of the experimental group Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group
Change in Short Physical Performance Battery (SPPB)	-0.2 units on a scale Interval -0.9 to 0.4	-0.1 units on a scale Interval -0.8 to 0.5

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Combined Experimental Group n=13 Participants Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group	Wait-list-control Group n=11 Participants Randomly selected for study assessments parallel with experimental group. Participates in MOBA after completion of the experimental group Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group
Change in Endurance as Measured by the 6-Minute Walk Test (6MWT)	-39.9 feet walked in six minutes Interval -229.0 to 150.0	-87.5 feet walked in six minutes Interval -267.0 to 92.0

SECONDARY outcome

Timeframe: Baseline, 10 weeks

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).

Outcome measures

Outcome measures
Measure	Combined Experimental Group n=13 Participants Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group	Wait-list-control Group n=11 Participants Randomly selected for study assessments parallel with experimental group. Participates in MOBA after completion of the experimental group Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group
Change in Behavioral Activation as Measured by the Behavioral Activation for Depression Scale (Short Form, BADS-SF).	2.6 units on a scale Interval -0.9 to 6.2	5.8 units on a scale Interval 2.1 to 9.5

SECONDARY outcome

Timeframe: Baseline, 10 weeks

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).

Outcome measures

Outcome measures
Measure	Combined Experimental Group n=13 Participants Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group	Wait-list-control Group n=11 Participants Randomly selected for study assessments parallel with experimental group. Participates in MOBA after completion of the experimental group Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group
Change in Self-Reported Sedentary Time on the Past-day Adults' Sedentary Time Questionnaire (PAST)	-1.0 hours per day Interval -2.1 to 0.1	-0.3 hours per day Interval -1.3 to 0.8

SECONDARY outcome

Timeframe: Baseline, 10 weeks

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).

Outcome measures

Outcome measures
Measure	Combined Experimental Group n=13 Participants Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group	Wait-list-control Group n=11 Participants Randomly selected for study assessments parallel with experimental group. Participates in MOBA after completion of the experimental group Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group
Change in Self-Reported Minutes of Moderate-to-Vigorous Physical Activity (MVPA)	78.4 minutes per week Interval 29.0 to 127.0	16.2 minutes per week Interval -23.8 to 56.3

SECONDARY outcome

Timeframe: Baseline, 10 weeks

The Barriers to Being Active Quiz has a score range from 0-63, with higher scores reflecting greater perceived barriers to activity.

Outcome measures

Outcome measures
Measure	Combined Experimental Group n=13 Participants Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group	Wait-list-control Group n=11 Participants Randomly selected for study assessments parallel with experimental group. Participates in MOBA after completion of the experimental group Mobility-Oriented Behavioral Activation: 10-weeks of mobility-oriented behavioral activation group
Change in Perceived Barriers to Activity	3.9 score on a scale Interval -4.8 to 12.6	0.4 score on a scale Interval -8.7 to 9.5

Adverse Events

Experimental Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait-list-control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Guy G. Potter, PhD

Duke University

Phone: 919-668-1269

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place