Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04851587
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2021-04-01
Brief Title:
EMPOWER Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The central objective of research is to examine the feasibility and acceptability of an 8-month single-arm behavioral intervention ie EMPOWER among overweightobese 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 andor 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 overweightobesity 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 overweightobesity 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 overweightobesity BMI25 kgm2 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
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 overweightobesity BMI25 kgm2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21AG070642-01 | NIH | None | httpsreporternihgovquickSearch1R21AG070642-01 |