N/A
Completed N=37
EMPOWER: Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward
Source: ClinicalTrials.gov NCT04851587 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: 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). — 6.9 score on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
6.9 | — |
| PRIMARY Global Treatment Engagement |
17 | — |
| PRIMARY Participant Satisfaction |
3.7 | — |
| PRIMARY Treatment Credibility |
7.8 | — |
| PRIMARY Enrollment Rate |
0.52 | — |
| PRIMARY Participant Retention |
19 | — |
| SECONDARY Body Weight Change |
-2.89 | — |
| SECONDARY Pain Impact Change |
-4.0 | — |
| SECONDARY Pleasant Activity Engagement |
64.7; 28.0 | — |
| SECONDARY Meaningful Activity Participation Change |
6.36 | — |
| SECONDARY Global Treatment Engagement |
17 | — |
Eligibility Criteria
Inclusion Criteria
- 45-80 years of age
- Have a BMI≥25kg/m2
- Endorse pain in the lower back region (i.e., space between the lower posterior margin of the rib cage and the horizontal gluteal fold), knees, or hips
- Pain must occur on at least 50% of the days in the previous six months
- Pain must be rated, at minimum, of moderate intensity (rating of 3 on a numeric rating scale ranging from 0-10)
- Pain impact must be rated as moderate to severe
- Study physician reviews medical record and declares patient medically appropriate for exercise protocol
Exclusion Criteria
- Current participation in another psychological treatment or structured weight loss program
- Severe psychiatric illness not adequately controlled by medication or other conditions anticipated to impair intervention engagement (e.g., substance abuse/dependence)
- Presence of chronic, malignant pain (e.g., cancer)
- Significant cognitive impairment ( 4 weeks prior to the baseline assessment
- Blood pressure higher than 180/100 mm Hg at baseline assessment
- Has had bariatric surgery in the past year or is planning to have it in the next year
- If participant reports the presence of systemic inflammatory disease (e.g., rheumatoid arthritis), the study physician will be consulted to determine eligibility
Data sourced from ClinicalTrials.gov (NCT04851587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.