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

Not Applicable

Completed

Conditions: Low Back Pain

Registration Number: NCT04851587

Lead Sponsor: University of Florida

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 37

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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).	Assessed at each session (every other week) up to 8 months	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.
Participant Satisfaction	Month 8	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.
Treatment Credibility	Baseline	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.
Enrollment Rate	63 Weeks	Number of participants enrolled per week during active recruitment.
Participant Retention	Baseline to 8 Months	Percentage of enrolled participants who complete the 8-month time-point.
Global Treatment Engagement	Baseline to 4 months	Number of participants who completed the intervention (defined as attending the final group session)

Secondary Outcome Measures

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