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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 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.

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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

Interventions

  • BEHAVIORAL MORPH

Study Locations (1)

North Carolina

  • Wake Forest University - Winston-Salem

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2021-01-01
Est. Completion 2025-10
Phase NA

Sponsor

Wake Forest University

100 total trials

What the Registry Record Tells You About NCT04655001

The ClinicalTrials.gov registry entry for NCT04655001 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (95% lower). The listed sponsor is Wake Forest University, which has 100 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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