Back to resultsEMPOWER: Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward
Primary Purpose
Low Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-Person (or Remote) Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Back Pain, Obesity, Aging, Overweight
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, Shawn McGargill, MD, 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
Sites / Locations
- University of FloridaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
In-Person (or Remote) Intervention Visits
Arm 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.
Outcomes
Primary Outcome Measures
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. Higher scores indicate greater treatment engagement.
Global Treatment Engagement
Percentage of participants who attend intervention sessions, defined as ≥80% attendance at sessions overall, and ≥70 attendance at both group and phone sessions considered separately.
Participant Satisfaction
8-item Client Satisfaction Questionnaire: Response to self-reported quality of the treatment, willingness to recommend the treatment, and general satisfaction with the treatment. Items are rated on a 1 to 4 scale with the mean value calculated. Higher scores indicate greater satisfaction with the treatment.
Participant Satisfaction
8-item Client Satisfaction Questionnaire: Response to self-reported quality of the treatment, willingness to recommend the treatment, and general satisfaction with the treatment. Items are rated on a 1 to 4 scale with the mean value calculated. Higher scores indicate greater satisfaction with the treatment.
Treatment Credibility
Treatment Expectation Questionnaire: 7-item study-adapted questionnaire assessing the credibility and reasonableness of the intervention, and expectation for change in pain and weight. Items are rated on a 0 to 10 scale or a 0% to 100% scale. Higher scores indicate greater treatment credibility and expectation for improvement.
Enrollment Rate
Percentage of participants who enroll that commence treatment.
Recruitment Rate
Percentage of participants enrolled per week during active recruitment.
Participant Retention
Percentage of enrolled participants who complete the 8-month time-point.
Secondary Outcome Measures
Body Weight
Percentage of body weight reduction as measured in kilograms by digital scale
Pain Impact
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.
Pleasant Activity Engagement
Percentage of pleasant activity goals met based on standardized self-report at the beginning of each phone session.
Meaningful Activity Participation
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). Higher scores indicate greater frequency and meaningfulness of activities.
Full Information
NCT ID
NCT04851587
First Posted
April 1, 2021
Last Updated
May 9, 2023
Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04851587
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Back Pain, Obesity, Aging, Overweight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
In-Person (or Remote) Intervention Visits
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
In-Person (or Remote) Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Description
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. Higher scores indicate greater treatment engagement.
Time Frame
Baseline to 8 months
Title
Global Treatment Engagement
Description
Percentage of participants who attend intervention sessions, defined as ≥80% attendance at sessions overall, and ≥70 attendance at both group and phone sessions considered separately.
Time Frame
Baseline to 8 months
Title
Participant Satisfaction
Description
8-item Client Satisfaction Questionnaire: Response to self-reported quality of the treatment, willingness to recommend the treatment, and general satisfaction with the treatment. Items are rated on a 1 to 4 scale with the mean value calculated. Higher scores indicate greater satisfaction with the treatment.
Time Frame
Month 4
Title
Participant Satisfaction
Description
8-item Client Satisfaction Questionnaire: Response to self-reported quality of the treatment, willingness to recommend the treatment, and general satisfaction with the treatment. Items are rated on a 1 to 4 scale with the mean value calculated. Higher scores indicate greater satisfaction with the treatment.
Time Frame
Month 8
Title
Treatment Credibility
Description
Treatment Expectation Questionnaire: 7-item study-adapted questionnaire assessing the credibility and reasonableness of the intervention, and expectation for change in pain and weight. Items are rated on a 0 to 10 scale or a 0% to 100% scale. Higher scores indicate greater treatment credibility and expectation for improvement.
Time Frame
Baseline
Title
Enrollment Rate
Description
Percentage of participants who enroll that commence treatment.
Time Frame
Baseline to Week 1
Title
Recruitment Rate
Description
Percentage of participants enrolled per week during active recruitment.
Time Frame
Baseline to 8 Months
Title
Participant Retention
Description
Percentage of enrolled participants who complete the 8-month time-point.
Time Frame
Baseline to 8 Months
Secondary Outcome Measure Information:
Title
Body Weight
Description
Percentage of body weight reduction as measured in kilograms by digital scale
Time Frame
Baseline, 4 months, 8 months
Title
Pain Impact
Description
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.
Time Frame
Baseline, 4 months, 8 months
Title
Pleasant Activity Engagement
Description
Percentage of pleasant activity goals met based on standardized self-report at the beginning of each phone session.
Time Frame
Baseline to 8 Months
Title
Meaningful Activity Participation
Description
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). Higher scores indicate greater frequency and meaningfulness of activities.
Time Frame
Baseline, 4 months, 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kasey Page, B.S
Phone
352-273-8798
Email
kpage@dental.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily J Bartley, Ph.D
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Megan A McVay, Ph.D
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Bartley, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
EMPOWER: Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward
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