Trial Outcomes & Findings for EMPOWER: Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward (NCT NCT04851587)
NCT ID: NCT04851587
Last Updated: 2025-06-06
Results Overview
Treatment Engagement Questionnaire: 6-item study-adapted questionnaire assessing perceptions of engagement, interest in the session content, and usefulness of the home activities. Items are rated on a 0 to 8 scale with the mean value across sessions calculated. The total scale is create by taking the mean of the items, and has a possible range of 0 (minimum) to 8 (maximum) score. There are no subscales. Higher scores indicate greater treatment engagement.
COMPLETED
NA
37 participants
Assessed at each session (every other week) up to 8 months
2025-06-06
Participant Flow
Recruitment for this single-arm clinical trial began in November 2021, with the last participant enrolled in January 2023. Participants with chronic musculoskeletal pain were recruited via the University of Florida Health System's clinical and administrative database. Additionally, patients were approached after their appointments at a a specialty spine clinic, and referrals were made from spine clinic providers. Recruitment took place at UF Health in the Gainesville and Jacksonville area.
Of the 132 individuals who expressed interest in the study and completed prescreening, 37 participants were eligible and enrolled. Of the 37 individuals who were enrolled, 33 participants commenced treatment.
Participant milestones
| Measure |
Empower Intervention
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
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Overall Study
STARTED
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37
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Overall Study
Received the Intervention
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33
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Overall Study
COMPLETED
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19
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Overall Study
NOT COMPLETED
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18
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Reasons for withdrawal
| Measure |
Empower Intervention
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
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Overall Study
Lost to Follow-up
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18
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Baseline Characteristics
EMPOWER: Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward
Baseline characteristics by cohort
| Measure |
Empower Intervention
n=33 Participants
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
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Age, Continuous
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60.9 years
STANDARD_DEVIATION 6.9 • n=99 Participants
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Sex: Female, Male
Female
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24 Participants
n=99 Participants
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Sex: Female, Male
Male
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9 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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31 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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12 Participants
n=99 Participants
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Race (NIH/OMB)
White
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19 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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2 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Region of Enrollment
United States
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33 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Assessed at each session (every other week) up to 8 monthsTreatment Engagement Questionnaire: 6-item study-adapted questionnaire assessing perceptions of engagement, interest in the session content, and usefulness of the home activities. Items are rated on a 0 to 8 scale with the mean value across sessions calculated. The total scale is create by taking the mean of the items, and has a possible range of 0 (minimum) to 8 (maximum) score. There are no subscales. Higher scores indicate greater treatment engagement.
Outcome measures
| Measure |
Empower Intervention
n=19 Participants
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
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Session-level Engagement (NOTE: This is a Pilot Study and There is Not a True Primary Outcome. There Are Several Descriptive Outcomes That Will Inform Our Decision to Proceed to a Traditional, Fully Powered Clinical Trial).
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6.9 score on a scale
Standard Deviation 1.2
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PRIMARY outcome
Timeframe: Baseline to 4 monthsNumber of participants who completed the intervention (defined as attending the final group session)
Outcome measures
| Measure |
Empower Intervention
n=33 Participants
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
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Global Treatment Engagement
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25 Participants
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PRIMARY outcome
Timeframe: Month 4Population: all assessed at 4 months
A single treatment satisfaction item ("In an overall, general sense, how satisfied are you with the intervention program you received?"). This item was rated on a 1 to 4 scale, with a higher score indicating greater satisfaction with the treatment.
Outcome measures
| Measure |
Empower Intervention
n=26 Participants
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
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Participant Satisfaction
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3.5 units on a scale
Standard Deviation 0.66
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PRIMARY outcome
Timeframe: Month 8Population: Those completing 8 month assessment
A single treatment satisfaction item ("In an overall, general sense, how satisfied are you with the intervention program you received?"). This item was rated on a 1 to 4 scale, with a higher score indicating greater satisfaction with the treatment.
Outcome measures
| Measure |
Empower Intervention
n=19 Participants
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
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Participant Satisfaction
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3.7 score on a scale
Standard Deviation 0.45
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PRIMARY outcome
Timeframe: BaselineTreatment Expectation Questionnaire: 7-item study-developed questionnaire assessing the credibility and reasonableness of the intervention. Items are rated on a 0 to 10 scale. A mean score was calculated for the questionnaire. Higher scores were indicative of greater treatment credibility.
Outcome measures
| Measure |
Empower Intervention
n=33 Participants
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
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Treatment Credibility
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7.8 score on a scale
Standard Deviation 1.3
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PRIMARY outcome
Timeframe: Baseline to Week 1Population: Those who were eligible and consented
Percentage of participants who enroll that commence treatment.
Outcome measures
| Measure |
Empower Intervention
n=37 Participants
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
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Enrollment Rate
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33 Participants
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PRIMARY outcome
Timeframe: 63 WeeksNumber of participants enrolled per week during active recruitment.
Outcome measures
| Measure |
Empower Intervention
n=33 Participants
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
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Enrollment Rate
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0.52 participants enrolled per week
Standard Deviation 0.90
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PRIMARY outcome
Timeframe: Baseline to 8 MonthsPopulation: All who commence treatment
Percentage of enrolled participants who complete the 8-month time-point.
Outcome measures
| Measure |
Empower Intervention
n=33 Participants
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
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Participant Retention
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19 Participants
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SECONDARY outcome
Timeframe: 4 monthsPopulation: Completed 4 month assessment
Kilograms weight change from baseline to 4 months measured by digital scale
Outcome measures
| Measure |
Empower Intervention
n=26 Participants
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
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Body Weight Change
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-2.89 kilograms
Interval -4.61 to -1.16
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SECONDARY outcome
Timeframe: 4 monthsPopulation: Those completing 4 month assessment
Research Task Force Impact Stratification Questionnaire: 9-items derived from the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form assessing pain intensity, pain interference with normal activities, and functional status. Impact stratification scores range from 8 (mild impact) to 50 (severe impact), with higher scores indicative of greater pain impact.Score represents change from baseline to 4 month assessment.
Outcome measures
| Measure |
Empower Intervention
n=26 Participants
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
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Pain Impact Change
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-4.0 score on a scale
Interval -6.77 to -1.31
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SECONDARY outcome
Timeframe: Baseline to 8 MonthsPopulation: Percentage of participants meeting partial or full weekly pleasant activity engagement goals.
Percentage of pleasant activity goals met based on standardized self-report at the beginning of each phone session. Participants were queried on whether they achieved their weekly goal with the following response options (yes, no, partially). Frequencies for goal attainment were conducted, with percentage of goals met calculated across participants.
Outcome measures
| Measure |
Empower Intervention
n=26 Participants
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
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Pleasant Activity Engagement
Full Goals Met
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64.7 percentage of participants
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Pleasant Activity Engagement
Partial Goals Met
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28.0 percentage of participants
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SECONDARY outcome
Timeframe: 4 monthsPopulation: Those completing 4 month survey
Meaningful Activity Participation Assessment Questionnaire: 28-item checklist reflecting common activities that are meaningful to older adults. Items are rated both for how much time is spent on activities and how meaningful the activities are perceived to be. Items are rated on a 1 to 7 scale for frequency of activities and on a 1 to 5 scale for meaningfulness (summative values calculated). Meaningful Activity Participation Assessment scores can range from 0 to 672. Higher scores indicate greater frequency and meaningfulness of activities. Change from baseline to 4 months
Outcome measures
| Measure |
Empower Intervention
n=26 Participants
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
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Meaningful Activity Participation Change
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6.36 score on a scale
Interval -28.2 to 40.92
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SECONDARY outcome
Timeframe: Baseline to 8 monthsNumber of participants who completed the intervention (defined as attending the final 8 month treatment session)
Outcome measures
| Measure |
Empower Intervention
n=33 Participants
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
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Global Treatment Engagement
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17 Participants
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Adverse Events
In-Person (or Remote) Intervention Visits
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place