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

Last updated: May 20, 2025
Sponsor: University of Florida
Overall Status: Completed

Phase

N/A

Condition

Obesity

Diabetes Prevention

Chronic Pain

Treatment

In-Person (or Remote) Intervention

Clinical Study ID

NCT04851587
IRB202002133-N
1R21AG070642-01
  • Ages 45-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 posteriormargin 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 numericrating scale ranging from 0-10)

  • Pain impact must be rated as moderate to severe

  • Study physician reviews medical record and declares patient medically appropriatefor exercise protocol

Exclusion

Exclusion Criteria:

  • Current participation in another psychological treatment or structured weight lossprogram

  • Severe psychiatric illness not adequately controlled by medication or otherconditions anticipated to impair intervention engagement (e.g., substanceabuse/dependence)

  • Presence of chronic, malignant pain (e.g., cancer)

  • Significant cognitive impairment (<26) on the Montreal Cognitive Assessment (MoCA)

  • Inability to read and write English

  • Currently undergoing radiation or chemotherapy for cancer

  • Self-reported cardiac event in the past 6 months or self-reported Heart Failure (CHF)

  • Currently pregnant or breastfeeding, or planning to become pregnant during the studytime period

  • Back, knee, or hip surgery within the past six months of study entry (or plannedsurgical interventions for pain during forecasted study participation)

  • If currently taking prescription analgesic or psychotropic medication, must bestabilized on these treatments for >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 nextyear

  • If participant reports the presence of systemic inflammatory disease (e.g.,rheumatoid arthritis), the study physician will be consulted to determineeligibility

Study Design

Total Participants: 37
Treatment Group(s): 1
Primary Treatment: In-Person (or Remote) Intervention
Phase:
Study Start date:
November 12, 2021
Estimated Completion Date:
January 31, 2024

Study Description

Chronic low back pain (cLBP) is the leading cause of disability worldwide and is one of the top reasons for seeking healthcare. High-impact low back pain is particularly problematic, defined as chronic pain accompanied by significant restrictions in work, social, and/or self-care activities for six months or more. High-impact pain is associated with greater pain-related disability, opioid use, and healthcare costs compared to pain of lower impact. Thus, efforts to reduce chronic pain impact have become a public health initiative. Low back pain and overweight/obesity are highly comorbid; overweight and obese individuals are up to 43% more likely to have cLBP compared to normal weight individuals. Together, the additive effects of overweight/obesity and chronic pain may play a larger role in increasing the risk for other adverse health-related comorbidities.

The aim of this exploratory study is to examine the feasibility and acceptability of an integrated pain and weight management intervention (EMPOWER) for middle-aged and older adults with moderate-to-high impact low back pain by addressing mechanisms of environmental reward and positive affect. Forty adults (ages 45-80 years) with comorbid overweight/obesity (BMI≥25 kg/m2) and moderate-to-high impact cLBP will be assigned to an 8-month intervention, whereby they will receive a group- and telephone-based program featuring integrated behavioral weight loss treatment and cognitive-behavioral pain coping therapy. To address the key mechanisms of environmental reward and positive affect, the proposed intervention will incorporate systematic pleasant activity scheduling and values-clarification techniques. Assessments will be conducted at baseline and at the 4- and 8-month time points.

Connect with a study center

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

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