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

University of Florida

Status: Completed

Conditions: Low Back Pain

Treatments: Behavioral: In-Person (or Remote) Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04851587

1R21AG070642-01 (U.S. NIH Grant/Contract)

IRB202002133-N

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

In-Person (or Remote) Intervention Visits

Experimental group

Description:

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.

Treatment:

Behavioral: In-Person (or Remote) Intervention