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

NCT04851587 | Completed Results

• 2 other identifiers: IRB202002133-N1R21AG070642-01
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain

Keywords

Back Pain; Obesity; Aging; Overweight

Outcome Measures

Primary Outcomes (8)

• 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).

  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.

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

• Global Treatment Engagement

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

  Baseline to 4 months

• Participant Satisfaction

  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.

  Month 4

• Participant Satisfaction

  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.

  Month 8

• Treatment Credibility

  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.

  Baseline

• Enrollment Rate

  Percentage of participants who enroll that commence treatment.

  Baseline to Week 1

• Enrollment Rate

  Number of participants enrolled per week during active recruitment.

  63 Weeks

• Participant Retention

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

  Baseline to 8 Months

Secondary Outcomes (5)

• Body Weight Change

  4 months

• Pain Impact Change

  4 months

• Pleasant Activity Engagement

  Baseline to 8 Months

• Meaningful Activity Participation Change

  4 months

• Global Treatment Engagement

  Baseline to 8 months

Study Arms (1)

In-Person (or Remote) Intervention Visits

EXPERIMENTAL

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 will be delivered every-other week and phone calls will occur every-other week (during weeks with no group). Sessions will be administered by a study interventionist with bachelors- or masters-level training and certification in health education or a related field (e.g., Certified Health Education Specialist), and materials will be developed to be appropriate for delivery by this level of training, given the potential for greater availability of these types of health professionals.

Behavioral: In-Person (or Remote) Intervention

Interventions

In-Person (or Remote) Intervention BEHAVIORAL

Participants will be 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.

In-Person (or Remote) Intervention Visits

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 (\<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 study time period
• 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
• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• McVay MA, Scotti K, Cheong J, McGargill S, Anton SA, Bartley EJ. Addressing co-occurring chronic pain and obesity simultaneously in a behavioral intervention: a pilot trial. Pilot Feasibility Stud. 2026 Jan 31. doi: 10.1186/s40814-026-01764-3. Online ahead of print.

  PMID: 41620768 DERIVED

MeSH Terms

Conditions

Low Back Pain; Back Pain; Obesity; Overweight

Interventions

Methods

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Emily Bartley
• Organization: University of Florida

EBartley@dental.ufl.edu

352-273-8934

Study Officials

• Emily J Bartley, Ph.D

  University of Florida

  PRINCIPAL INVESTIGATOR

• Megan A McVay, Ph.D

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 20, 2021
• Study Start: November 12, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: June 6, 2025
• Results First Posted: June 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)