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

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: In-Person (or Remote) Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 (<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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: In-Person (or Remote) Intervention Visits; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment Rate	Percentage of participants who enroll that commence treatment.	Baseline to Week 1
Participant Retention	Percentage of enrolled participants who complete the 8-month time-point.	Baseline to 8 Months
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	Number of participants enrolled per week during active recruitment.	63 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight Change	Kilograms weight change from baseline to 4 months measured by digital scale	4 months
Pain Impact Change	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.	4 months
Pleasant Activity Engagement	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.	Baseline to 8 Months
Meaningful Activity Participation Change	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	4 months
Global Treatment Engagement	Number of participants who completed the intervention (defined as attending the final 8 month treatment session)	Baseline to 8 months

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Emily J Bartley, Ph.D, University of Florida; Principal Investigator: Megan A McVay, Ph.D, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2021
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Aging; Back Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nutrition Disorders; Overnutrition; Body Weight; Overweight; Back Pain; Obesity; Low Back Pain
• Other Study ID Numbers: IRB202002133-N; 1R21AG070642-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No