University of Florida
Gainesville, Florida, 32610, United States
NCT Number: NCT04851587
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.
Looking for future studies?
Notify Me45 year–80 year
All sexes
Interventional
Not applicable
Gainesville, Florida, 32610, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: Baseline to 4 months
Number of participants who completed the intervention (defined as attending the final group session)
Time frame: Month 4
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 1
Percentage of participants who enroll that commence treatment.
Time frame: 63 Weeks
Number of participants enrolled per week during active recruitment.
Time frame: Baseline to 8 Months
Percentage of enrolled participants who complete the 8-month time-point.
Time frame: 4 months
Kilograms weight change from baseline to 4 months measured by digital scale
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline to 8 months
Number of participants who completed the intervention (defined as attending the final 8 month treatment session)
University of Florida
Other
Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07173335
Arthritis, Back Pain
Lismore, New South Wales, Australia
View Trial DetailsNCT04246281
Back Pain, Low Back Pain
Little Rock, Arkansas, United States
View Trial DetailsNCT06835439
Back Pain, Chronic Pain
San Diego, California, United States
View Trial DetailsNCT06114264
Back Pain, Behavior
Granada, Spain
View Trial Details