NCT04851587

EMPOWER: Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward

Completed NA Results posted Last updated 6 June 2025

What this trial tests

NA trial testing In-Person (or Remote) Intervention in Low Back Pain in 37 participants. Completed in 31 January 2024.

Timeline

12 November 2021

Primary endpoint
31 January 2024

31 January 2024

Quick facts

Lead sponsor	University of Florida
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	12 November 2021
Primary completion	31 January 2024
Estimated completion	31 January 2024
Sites	1 location across United States

Drugs / interventions tested

• In-Person (or Remote) Intervention

Conditions studied

• Low Back Pain — all drugs for Low Back Pain →

Sponsor

University of Florida

Who can join

Adults 45 to 80, any sex, with Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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). Primary · Assessed at each session (every other week) up to 8 months

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.

Group	Value	95% CI
Empower Intervention	6.9	± 1.2

Global Treatment Engagement Primary · Baseline to 4 months

Number of participants who completed the intervention (defined as attending the final group session)

Group	Value	95% CI
Empower Intervention	25

Participant Satisfaction Primary · Month 4

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.

Group	Value	95% CI
In-Person (or Remote) Intervention Visits	3.5	± 0.66

Participant Satisfaction Primary · Month 8

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.

Group	Value	95% CI
Empower Intervention	3.7	± 0.45

Treatment Credibility Primary · Baseline

Treatment 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.

Group	Value	95% CI
Empower Intervention	7.8	± 1.3

Enrollment Rate Primary · Baseline to Week 1

Percentage of participants who enroll that commence treatment.

Group	Value	95% CI
Empower Intervention	33

Enrollment Rate Primary · 63 Weeks

Number of participants enrolled per week during active recruitment.

Group	Value	95% CI
Empower Intervention	0.52	± 0.90

Participant Retention Primary · Baseline to 8 Months

Percentage of enrolled participants who complete the 8-month time-point.

Group	Value	95% CI
Empower Intervention	19

Body Weight Change Secondary · 4 months

Kilograms weight change from baseline to 4 months measured by digital scale

Group	Value	95% CI
Empower Intervention	-2.89	-4.61 – -1.16

Pain Impact Change Secondary · 4 months

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.

Group	Value	95% CI
Empower Intervention	-4.0	-6.77 – -1.31

Pleasant Activity Engagement Secondary · Baseline to 8 Months

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.

Full Goals Met

Group	Value	95% CI
In-Person (or Remote) Intervention Visits	64.7

Partial Goals Met

Group	Value	95% CI
In-Person (or Remote) Intervention Visits	28.0

Meaningful Activity Participation Change Secondary · 4 months

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

Group	Value	95% CI
Empower Intervention	6.36	-28.20 – 40.92

Sponsor's own description

The central objective of research is to examine the feasibility and acceptability of an 8-month single-arm behavioral intervention (i.e., EMPOWER) among overweight/obese middle-aged and older adults with moderate-to-high impact low back pain. Intervention content will focus on standard behavioral weight loss treatment and cognitive-behavioral pain coping therapy with a focus on environmental reward and positive affect.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Addressing co-occurring chronic pain and obesity simultaneously in a behavioral intervention: a pilot trial.
   McVay MA, Scotti K, Cheong J, McGargill S, et al · · 2026 · PMID 41620768 · DOI 10.1186/s40814-026-01764-3