Clinical trial NCT04851587: EMPOWER: Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward
Official title: Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Back Pain
Obesity
Aging
Overweight
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-04-20
Enrollment: 37
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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 (\<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

Primary outcomes:
measure: 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).
timeFrame: Assessed at each session (every other week) up to 8 months
measure: Global Treatment Engagement
timeFrame: Baseline to 4 months
measure: Participant Satisfaction
timeFrame: Month 4
measure: Participant Satisfaction
timeFrame: Month 8
measure: Treatment Credibility
timeFrame: Baseline
measure: Enrollment Rate
timeFrame: Baseline to Week 1
measure: Enrollment Rate
timeFrame: 63 Weeks
measure: Participant Retention
timeFrame: Baseline to 8 Months
Secondary outcomes:
measure: Body Weight Change
timeFrame: 4 months
measure: Pain Impact Change
timeFrame: 4 months
measure: Pleasant Activity Engagement
timeFrame: Baseline to 8 Months
measure: Meaningful Activity Participation Change
timeFrame: 4 months
measure: Global Treatment Engagement
timeFrame: Baseline to 8 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Emily J Bartley, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Megan A McVay, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: