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NCT04076722 · ClinicalTrials.gov registry record · NA
Neurotrophic Indicators of Cognition, Executive Skills, Plasticity, and Adverse Childhood Experiences Study
A NA study, sponsored by Oklahoma State University.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
NCT04076722: Completed NA study, sponsored by Oklahoma State University.
NCT04076722 is a NA study that has completed, run by Oklahoma State University. The registered enrollment target is 55 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04076722, a NA study, has completed, sponsored by Oklahoma State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
Study Summary
Adverse childhood experiences (ACEs) are repeatedly shown to predict negative biopsychosocial health outcomes, including obesity. High rates of ACEs in communities are often paralleled by high obesity rates, and higher ACEs, such as child abuse, have been shown to positively predict later obesity and use of unhealthy weight control behaviors. Thus, in light of the high prevalence of and potential causal links between early-life stress and obesity, there is a critical need to further explore the ACEs-obesity relationship in order to understand and to improve obesity outcomes. Given the adverse impact of ACEs and obesity on brain health, two potential high impact treatment targets of the ACEs-obesity relationship will be explored in the proposed pilot study: 1) markers of neurocognition (i.e., executive function; EF) and, 2) brain health/plasticity (i.e., neurotrophins like brain-derived neurotropic factor; BDNF and glial cell derived neurotrophic factor; GDNF). Specifically, this trial will be the first to 1) Identify whether brain markers of neural health (e.g., neurotrophins) are related to ACES and/or neurocognitive EF performance, and 2) Test whether neuronal or glial neurotrophins predict or change in response to weight loss. Addressing these two needs advances the science of whether ACEs and EF levels are differentially related to brain indices of neural and glial health/plasticity. Results of this pilot may identify a neural substrate and/or profile by which ACEs promote obesity that may ultimately be more amenable to pharmacologic intervention in order to promote weight loss outcomes. This group-treatment trial will assess 48 obese adults randomized to either an 8-week behavioral weight loss treatment group (n=24) or a wait list control (n=24). Our primary endpoints are percent reductions in body weight and changes in neurotrophins (e.g., BDNF, GDNF). Weight and blood specimens will be assessed at baseline, post-treatment (8-weeks), and follow-up (12-weeks)
Primary Outcome
Changes in BDNF
Interventions
- BEHAVIORAL Stress reactivity stimuli
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2019-12-04 |
| Est. Completion | 2020-12-11 |
| Phase | NA |
What the finished NCT04076722 record still lists
NCT04076722 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Stress reactivity stimuli is the first listed.
NCT04076722 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04076722 about?
NCT04076722 is a clinical study titled "Neurotrophic Indicators of Cognition, Executive Skills, Plasticity, and Adverse Childhood Experiences Study". Adverse childhood experiences (ACEs) are repeatedly shown to predict negative biopsychosocial health outcomes, including obesity. High rates of ACEs in communities are often paralleled by high obesity rates, and higher ACEs, such as child abuse, have been shown to positively predict later obesity an...
What is the current status of trial NCT04076722?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2019-12-04. Estimated completion is 2020-12-11.
What interventions are being tested in trial NCT04076722?
The interventions under investigation include: Stress reactivity stimuli (BEHAVIORAL).
Who is sponsoring clinical trial NCT04076722?
This trial is sponsored by Oklahoma State University, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04076722's enrollment target sits among peer trials
55 1264th of 2000 higher than 733 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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