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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 is a NA study that has completed, run by Oklahoma State University. The registered enrollment target is 55 participants.
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)
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04076722
The ClinicalTrials.gov registry entry for NCT04076722 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oklahoma State University, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Stress reactivity stimuli is the first listed.
NCT04076722 reports 0 study locations.
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.
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