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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG070642-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-Person (or Remote) Intervention Visits | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-Person (or Remote) Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. 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. | Assessed at each session (every other week) up to 8 months |
| Global Treatment Engagement | Number of participants who completed the intervention (defined as attending the final group session) | Baseline to 4 months |
| Participant Satisfaction | 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. | Month 4 |
| Participant Satisfaction | 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. | Month 8 |
| Treatment Credibility | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight Change | Kilograms weight change from baseline to 4 months measured by digital scale | 4 months |
| Pain Impact Change | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily J Bartley, Ph.D | University of Florida | Principal Investigator |
| Megan A McVay, Ph.D | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41620768 | Derived | McVay MA, Scotti K, Cheong J, McGargill S, Anton SA, Bartley EJ. Addressing co-occurring chronic pain and obesity simultaneously in a behavioral intervention: a pilot trial. Pilot Feasibility Stud. 2026 Jan 31;12(1):33. doi: 10.1186/s40814-026-01764-3. |
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Of the 132 individuals who expressed interest in the study and completed prescreening, 37 participants were eligible and enrolled. Of the 37 individuals who were enrolled, 33 participants commenced treatment.
Recruitment for this single-arm clinical trial began in November 2021, with the last participant enrolled in January 2023. Participants with chronic musculoskeletal pain were recruited via the University of Florida Health System's clinical and administrative database. Additionally, patients were approached after their appointments at a a specialty spine clinic, and referrals were made from spine clinic providers. Recruitment took place at UF Health in the Gainesville and Jacksonville area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Empower Intervention | 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 were delivered every-other week and phone calls will occur every-other week (during weeks with no group). Participants were 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Consented and started the intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | Empower Intervention | 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 were delivered every-other week and phone calls will occur every-other week (during weeks with no group). Participants were 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at each session (every other week) up to 8 months |
|
8 months
Description of adverse event conforms to clinical trials .gov definition. Data was collected non-systematically.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | In-Person (or Remote) Intervention Visits | 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. In-Person (or Remote) Intervention: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Bartley | University of Florida | 352-273-8934 | EBartley@dental.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2022 | Mar 18, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 11, 2022 | Mar 18, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| Baseline |
| Enrollment Rate | Percentage of participants who enroll that commence treatment. | Baseline to Week 1 |
| Enrollment Rate | Number of participants enrolled per week during active recruitment. | 63 Weeks |
| Participant Retention | Percentage of enrolled participants who complete the 8-month time-point. | Baseline to 8 Months |
| 4 months |
| Pleasant Activity Engagement | 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. | Baseline to 8 Months |
| Meaningful Activity Participation Change | 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 | 4 months |
| Global Treatment Engagement | Number of participants who completed the intervention (defined as attending the final 8 month treatment session) | Baseline to 8 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Global Treatment Engagement | Number of participants who completed the intervention (defined as attending the final group session) | Posted | Count of Participants | Participants | Baseline to 4 months |
|
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| Primary | Participant Satisfaction | 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. | all assessed at 4 months | Posted | Mean | Standard Deviation | units on a scale | Month 4 |
|
|
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| Primary | Participant Satisfaction | 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. | Those completing 8 month assessment | Posted | Mean | Standard Deviation | score on a scale | Month 8 |
|
|
|
| Primary | Treatment Credibility | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
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| Primary | Enrollment Rate | Percentage of participants who enroll that commence treatment. | Those who were eligible and consented | Posted | Count of Participants | Participants | Baseline to Week 1 |
|
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| Primary | Enrollment Rate | Number of participants enrolled per week during active recruitment. | Posted | Mean | Standard Deviation | participants enrolled per week | 63 Weeks |
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| Primary | Participant Retention | Percentage of enrolled participants who complete the 8-month time-point. | All who commence treatment | Posted | Count of Participants | Participants | Baseline to 8 Months |
|
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| Secondary | Body Weight Change | Kilograms weight change from baseline to 4 months measured by digital scale | Completed 4 month assessment | Posted | Mean | 95% Confidence Interval | kilograms | 4 months |
|
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|
| Secondary | Pain Impact Change | 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. | Those completing 4 month assessment | Posted | Mean | 95% Confidence Interval | score on a scale | 4 months |
|
|
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| Secondary | Pleasant Activity Engagement | 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. | Percentage of participants meeting partial or full weekly pleasant activity engagement goals. | Posted | Number | percentage of participants | Baseline to 8 Months |
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| Secondary | Meaningful Activity Participation Change | 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 | Those completing 4 month survey | Posted | Mean | 95% Confidence Interval | score on a scale | 4 months |
|
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| Secondary | Global Treatment Engagement | Number of participants who completed the intervention (defined as attending the final 8 month treatment session) | Posted | Count of Participants | Participants | Baseline to 8 months |
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| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
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| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |