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NCT04655001 · ClinicalTrials.gov registry record · NA
Revisiting A Mobile Intervention to Reduce Pain and Improve Health
A NA study of Obesity and Pain, sponsored by Wake Forest University.
- Active
- Registry status
- NA
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT04655001: Active NA study of Obesity and Pain, sponsored by Wake Forest University.
NCT04655001 is a NA study of Obesity and Pain that is active but no longer recruiting, run by Wake Forest University. The registered enrollment target is 44 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04655001, a NA study of Obesity and Pain, is active but no longer recruiting, sponsored by Wake Forest University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
Chronic pain is a pervasive and costly health condition among older adults that is associated with wide-ranging adverse health outcomes including falls, declining mobility, and increasing functional disability. Obesity exacerbates many of these health issues, contributing to a higher frequency of intractable pain episodes, increased pain severity, multi-site pain, and the use of stronger opioid medications compared to normal weight individuals with chronic pain. In addition, older adults who suffer from chronic pain are significantly more sedentary than those without chronic pain. Despite evidence relating increased sedentary behavior to pain, non-pharmacological treatments have largely focused on structured moderate-to-vigorous physical activity (MVPA) by way of conventional forms of exercise. Recent evidence from an intervention designed to decreased sedentary behavior (SB) demonstrated the approach is effective in preventing weight regain following weight loss. A subsequent study-a mobile intervention to reduce pain and improve health (MORPH: Wake Forest Baptist Health institutional review board \[IRB\] 00046364)-demonstrated that a primarily home-delivered intervention (9 of 12 delivered in home; 3 of 12 delivered in a research center) supported by technology can produce significant weight loss, reductions in sedentary time, increases in daily steps, less pain intensity, and better physical function compared with a waitlist control. MORPH included a focus on dietary weight loss plus movement across the day through a combination of group telecoaching and a custom mobile health (mHealth) application, but results indicated that participants did not internalize the day-long movement intervention. Instead, they appeared to achieve a greater number of steps through conventional walking exercise, allowing for high levels of sitting, stiffness, and pain. MORPH concluded with a two-group randomized controlled pilot trial (RCT) in obese (BMI=30-45 kg/m2), low-active, ol
Primary Outcome
PROMIS (Patient-Reported Outcomes Measurement Information System) 3-item pain intensity scale. Final scores represent t-scores (mean of 50, standard deviation of 10) where greater scores represent greater pain intensity relative to a nationally representative sample.
Conditions Studied
Interventions
- BEHAVIORAL MORPH
Study Locations (1)
North Carolina
- Wake Forest University - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2025-10 |
| Phase | NA |
What the registry record for NCT04655001 still lists
NCT04655001 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which MORPH is the first listed.
NCT04655001 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04655001 about?
NCT04655001 is a clinical study titled "Revisiting A Mobile Intervention to Reduce Pain and Improve Health". Chronic pain is a pervasive and costly health condition among older adults that is associated with wide-ranging adverse health outcomes including falls, declining mobility, and increasing functional disability. Obesity exacerbates many of these health issues, contributing to a higher frequency of in...
What is the current status of trial NCT04655001?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 44 participants. The study started on 2021-01-01. Estimated completion is 2025-10.
What conditions does trial NCT04655001 study?
This clinical trial studies the following conditions: Obesity, Pain, Sedentary Behavior.
What interventions are being tested in trial NCT04655001?
The interventions under investigation include: MORPH (BEHAVIORAL).
Who is sponsoring clinical trial NCT04655001?
This trial is sponsored by Wake Forest University, which has 100 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04655001 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04655001's enrollment target sits among peer trials
44 760th of 1053 higher than 288 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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