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NCT04962321 · ClinicalTrials.gov registry record · NA
Wellness Education Intervention
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
NCT04962321: Completed NA study, sponsored by University of Texas Southwestern Medical Center.
NCT04962321 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 34 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04962321, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
Study Summary
Individuals suffering from depression and anxiety have an increased risk of obesity due to multiple factors such as side effects to psychotropic medications, associated appetite dysregulation, disruption of sleep, anergia leading to psychomotor retardation or inactivity, and increased stress hormones through the disruption in the hypothalamic-pituitary-adrenal (HPA) axis. Though not a causal relationship, an intimate bidirectional connection exists between the two conditions, which subsequently impacts the journey of weight loss. The impact mental health can have on weight loss is evident as concurrent depression and anxiety in individuals with obesity predicts poorer outcomes like decreased adherence and less success with weight loss interventions. Here, we will determine if delivery of psychoeducation regarding the primitive brain and model of safety in a group setting to those with obesity seeking weight loss intervention has an impact on not only psychiatric symptoms of depression and anxiety but also weight loss, eating behaviors, sleeping patterns, activity level, and health-related quality of life. This project will improve our understanding of the role of mental health and the stress response in obesity.
Primary Outcome
Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For our primary measure, we will use the physical health to examine pain interference and intensity. PROMIS raw scores range from 9-50; the PROMIS T-scores have a mean of 50 with a standard deviation of 10 and where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to
Interventions
- BEHAVIORAL Wellness Education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2021-07-19 |
| Est. Completion | 2022-10-12 |
| Phase | NA |
What the finished NCT04962321 record still lists
NCT04962321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Wellness Education is the first listed.
NCT04962321 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04962321 about?
NCT04962321 is a clinical study titled "Wellness Education Intervention". Individuals suffering from depression and anxiety have an increased risk of obesity due to multiple factors such as side effects to psychotropic medications, associated appetite dysregulation, disruption of sleep, anergia leading to psychomotor retardation or inactivity, and increased stress hormone...
What is the current status of trial NCT04962321?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2021-07-19. Estimated completion is 2022-10-12.
What interventions are being tested in trial NCT04962321?
The interventions under investigation include: Wellness Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT04962321?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04962321's enrollment target sits among peer trials
34 1570th of 2000 higher than 427 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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