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Behavioral Intervention
Weight Loss and Pain Coping Intervention for Obesity with Lower Back Pain
N/A
Recruiting
Led By Emily J Bartley, Ph.D
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 months, 8 months
Awards & highlights
Study Summary
This trial will test the feasibility and acceptability of an 8-month weight loss and pain coping intervention for overweight/obese adults with moderate to high impact low back pain.
Who is the study for?
The EMPOWER trial is for overweight or obese adults aged 45-80 with moderate-to-high impact lower back pain. Participants must have a BMI of 25kg/m2 or higher and experience back pain on most days over the past six months. They should be medically fit for exercise, not involved in other weight loss programs, free from severe psychiatric illnesses, chronic malignant pain like cancer, recent major surgeries, or planning pregnancy.Check my eligibility
What is being tested?
This study tests an 8-month behavioral intervention called EMPOWER aimed at managing obesity and lower back pain in middle-aged to older adults. It combines standard weight loss treatment with cognitive-behavioral therapy focusing on increasing environmental rewards and positive feelings.See study design
What are the potential side effects?
Since this is a non-drug intervention focused on behavior change and coping strategies, typical medication side effects are not expected. However, participants may experience discomfort from new exercises or emotional distress when discussing painful experiences.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 months, 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 months, 8 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Enrollment Rate
Global Treatment Engagement
Participant Retention
+4 moreSecondary outcome measures
Body Weight
Meaningful Activity Participation
Pain Impact
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: In-Person (or Remote) Intervention VisitsExperimental Treatment1 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 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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Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,657 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,017,015 Total Patients Enrolled
Emily J Bartley, Ph.DPrincipal InvestigatorUniversity of Florida
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You must have at least moderate pain, which means a rating of 3 out of 10 on a pain scale.You have a significant problem with memory and thinking, as measured by a test called the Montreal Cognitive Assessment (MoCA).You are currently receiving radiation or chemotherapy for cancer.You have had a heart-related issue or heart failure in the past 6 months.You have long-lasting severe pain, such as from cancer.Your blood pressure is higher than 180/100 mm Hg when it was checked at the beginning.You had weight loss surgery in the last year or plan to have it in the next year.You had surgery on your back, knee, or hip in the last six months, or you are planning to have surgery for pain while the study is happening.If you have a condition that causes inflammation throughout your body, like rheumatoid arthritis, the study doctor will decide if you can join the trial.You must be between 45 and 80 years old.You weigh more than what is considered healthy for your height.You have pain in your lower back, knees, or hips.You have pain in your lower back, knees, or hips.You must have experienced pain on most days for the past six months.You must have moderate or severe pain, rated at least 3 out of 10 on a pain scale.You must have moderate to severe pain.
Research Study Groups:
This trial has the following groups:- Group 1: In-Person (or Remote) Intervention Visits
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research require participants to be of a certain age?
"To meet the conditions of this study, prospective participants must fall between 45 and 80 years old."
Answered by AI
Is there space available for participants in this experiment?
"This clinical trial, which was initially announced on November 12th 2021, is actively seeking applicants. The study's data has been updated recently - the last edit occured on September 8th 2022."
Answered by AI
What criteria must be met for a patient to qualify to participate in this clinical trial?
"This clinical trial, which is looking to enrol a total of 48 patients, requires participants have low back pain and are between the ages of 45-80."
Answered by AI
What is the participant quota for this research project?
"Affirmative. According to the data published on clinicaltrials.gov, this research initiative is currently in search of 48 participants from one site and has been active since November 12th 2021 with its last edit occurring September 8th 2022."
Answered by AI
What aims is the clinical trial attempting to attain?
"The investigative purpose of this research, which will be tracked from Baseline to 8 Months, is Participant Retention. Secondary objectives include Pleasant Activity Engagement (quantified through a Percentage of pleasant activity goals met based on standardized self-report at the start of each phone session), Body Weight reduction as quantified by digital scale in kilograms and Meaningful Activity Participation (rated across 28 items for frequency & meaningfulness). Higher scores illustrate higher commitment & value attributed to activities."
Answered by AI
Who else is applying?
What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
University of Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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