NCT04851587Completed
EMPOWER: Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward
Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward
Source: ClinicalTrials.gov · Last updated 6 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 37 (actual)
- First submitted
- 1 Apr 2021
- Start date
- 12 Nov 2021
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- University of Florida
- Diseases
- Obesity
- NCT number
- NCT04851587
What you commit to
- Study type: Interventional
- Participants enrolled: 37
- From 12 Nov 2021 to the primary completion date, 31 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Back, knee, or hip surgery within the past six months of study entry (or planned surgical interventions for pain during forecasted study participation)
- If currently taking prescription analgesic or psychotropic medication, must be stabilized on these treatments for \>4 weeks prior to the baseline assessment
- Has had bariatric surgery in the past year or is planning to have it in the next year
Other illness
- 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 (\<26) on the Montreal Cognitive Assessment (MoCA)
- Currently undergoing radiation or chemotherapy for cancer
- Self-reported cardiac event in the past 6 months or self-reported Heart Failure (CHF)
- If participant reports the presence of systemic inflammatory disease (e.g., rheumatoid arthritis), the study physician will be consulted to determine eligibility
Other
- Current participation in another psychological treatment or structured weight loss program
- Inability to read and write English
- Currently pregnant or breastfeeding, or planning to become pregnant during the study time period
- Blood pressure higher than 180/100 mm Hg at baseline assessment
Who the study is looking for
- 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
Age in the registry: 45 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
Related publications
- Addressing co-occurring chronic pain and obesity simultaneously in a behavioral intervention: a pilot trial.Pilot Feasibility Stud · 2026 · PMID 41620768
This page is information, not medical advice. Discuss any trial with your doctor.