Ignite Creation Date:
2024-05-06 @ 1:37 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04076722
Status:
COMPLETED
Last Update Posted:
2021-03-19
First Post:
2019-07-24
Brief Title:
Neurotrophic Indicators of Cognition Executive Skills Plasticity and Adverse Childhood Experiences Study
Sponsor:
Oklahoma State University
Organization:
Oklahoma State University
Study Overview
Official Title:
Neurotrophic Indicators of Cognition Executive Skills Plasticity and Adverse Childhood Experiences Study NICE SPACES
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NICE SPACES
Brief 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 ie executive function EF and 2 brain healthplasticity ie 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 eg neurotrophins are related to ACES andor 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 healthplasticity Results of this pilot may identify a neural substrate andor 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 n24 or a wait list control n24 Our primary endpoints are percent reductions in body weight and changes in neurotrophins eg BDNF GDNF Weight and blood specimens will be assessed at baseline post-treatment 8-weeks and follow-up 12-weeks In testing these endpoints we will meet the following aims 1 To test whether neurotrophins are related to ACEs and executive function EF and 2 To test if neurotrophins predict or change in response to weight loss trajectory
The above description describes the study design that was terminated prematurely due to Covid-19 The following description is the modified protocol
The treatment described above was canceled and the present study focused on the baseline visit In this visit participants participated in a stress reactivity protocol so instead of looking at change in BDNF GDNF and inflammatory markers after weight loss treatment we looked at change in BDNF GDNF and inflammatory markers after the stress activity task This information will tell us about how ACEs status is related to these biomarkers at baseline and in response to stress
Specifically this trial will be the first to 1 Identify whether brain markers of neural health eg neurotrophins are related to ACES andor 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 healthplasticity Results of this pilot may identify a neural substrate andor 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 n24 or a wait list control n24 Our primary endpoints are percent reductions in body weight and changes in neurotrophins eg BDNF GDNF Weight and blood specimens will be assessed at baseline post-treatment 8-weeks and follow-up 12-weeks In testing these endpoints we will meet the following aims 1 To test whether neurotrophins are related to ACEs and executive function EF and 2 To test if neurotrophins predict or change in response to weight loss trajectory
The above description describes the study design that was terminated prematurely due to Covid-19 The following description is the modified protocol
The treatment described above was canceled and the present study focused on the baseline visit In this visit participants participated in a stress reactivity protocol so instead of looking at change in BDNF GDNF and inflammatory markers after weight loss treatment we looked at change in BDNF GDNF and inflammatory markers after the stress activity task This information will tell us about how ACEs status is related to these biomarkers at baseline and in response to stress
Detailed Description:
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 ie executive function EF and 2 brain healthplasticity ie 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 eg neurotrophins are related to ACES andor 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 healthplasticity Results of this pilot may identify a neural substrate andor profile by which ACEs promotes 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 n24 or a wait list control n24 Our primary endpoints are percent reductions in body weight and changes in neurotrophins eg BDNF GDNF Weight and blood specimens will be assessed at baseline post-treatment 8-weeks and follow-up 12-weeks In testing these endpoints we will meet the following aims Aim 1 - To test whether neurotrophins are related to ACEs and executive function EF and Aim 2 To test if neurotrophins predict or change in response to weight loss trajectory To ensure the success of the trial we have assembled a team of experts in adult behavioral obesity treatment PI Hawkins PhD neurotrophins Consultant Vasquez PhD and biostatistics Consultant Washburn PhD The results of this study will advance the science of neurocognitive risk of weight loss difficulties and their potential treatment Our approach ensures that the neurocognitive testing and weight loss protocol can be delivered by trained non-experts improving its scalability and future dissemination potential The results could ultimately be used to tailor weight loss treatments such that neurocognitive risk factors related to ACES are identified early and may ultimately be proactively mitigated early in treatment to maximize participants lasting weight loss outcomes
The above description describes the study design that was terminated prematurely due to Covid-19 The following description is the modified protocol
The treatment described above was canceled and the present study focused on the baseline visit In this visit participants participated in a stress reactivity protocol so instead of looking at change in BDNF GDNF and inflammatory markers after weight loss treatment we looked at change in BDNF GDNF and inflammatory markers after the stress activity task This information will tell us about how ACEs status is related to these biomarkers at baseline and in response to stress
Specifically this trial will be the first to 1 Identify whether brain markers of neural health eg neurotrophins are related to ACES andor 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 healthplasticity Results of this pilot may identify a neural substrate andor profile by which ACEs promotes 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 n24 or a wait list control n24 Our primary endpoints are percent reductions in body weight and changes in neurotrophins eg BDNF GDNF Weight and blood specimens will be assessed at baseline post-treatment 8-weeks and follow-up 12-weeks In testing these endpoints we will meet the following aims Aim 1 - To test whether neurotrophins are related to ACEs and executive function EF and Aim 2 To test if neurotrophins predict or change in response to weight loss trajectory To ensure the success of the trial we have assembled a team of experts in adult behavioral obesity treatment PI Hawkins PhD neurotrophins Consultant Vasquez PhD and biostatistics Consultant Washburn PhD The results of this study will advance the science of neurocognitive risk of weight loss difficulties and their potential treatment Our approach ensures that the neurocognitive testing and weight loss protocol can be delivered by trained non-experts improving its scalability and future dissemination potential The results could ultimately be used to tailor weight loss treatments such that neurocognitive risk factors related to ACES are identified early and may ultimately be proactively mitigated early in treatment to maximize participants lasting weight loss outcomes
The above description describes the study design that was terminated prematurely due to Covid-19 The following description is the modified protocol
The treatment described above was canceled and the present study focused on the baseline visit In this visit participants participated in a stress reactivity protocol so instead of looking at change in BDNF GDNF and inflammatory markers after weight loss treatment we looked at change in BDNF GDNF and inflammatory markers after the stress activity task This information will tell us about how ACEs status is related to these biomarkers at baseline and in response to stress
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None