Weight LossNICE SPACESNCT04076722
Neurotrophic Indicators of Cognition, Executive Skills, Plasticity, and Adverse Childhood Experiences Study
A study testing Stress reactivity stimuli in people with Weight Loss and Wait-List Control, run by Oklahoma State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Wait-List Control
- What is being tested?
- Stress reactivity stimuli
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2019to 11 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- an overweight/obese body mass index (BMI = 25 kg/m2 or greater)
- English speaking
- No use of weight loss medications in the past 3 months,
- No history of or planning to undergo bariatric surgery during the study period,
- Not currently pregnant or breastfeeding or planning to become pregnant during the study period,
- Not already enrolled in a weight loss program (e.g., Weight Watchers ®),
Show all 11Show fewer
- No significant medical or psychiatric comorbidities, including uncontrolled metabolic disorders (e.g., thyroid, renal, liver), diabetes, heart disease, stroke, cancer, eating disorder, psychosis, mania, dementia, etc.,
- Physician determination that the study is appropriate or safe,
- Able to comply with the assessment procedures
- Able to provide informed consent or assent,
- Not planning to move during study period
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma State University
Stillwater, Oklahoma, 74078
About this study
Official title: Neurotrophic Indicators of Cognition, Executive Skills, Plasticity, and Adverse Childhood Experiences Study "NICE SPACES"
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.
Read more
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). 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.
Read the 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 (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 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 (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). 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.
- Conditions
- Weight Loss, Wait-List Control
- Being tested
- Stress reactivity stimuli
- Keywords
- Obesity, Weight Loss, Adverse childhood experiences, Executive function, Brain health
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress reactivity stimuliBehavioural
An evaluated speech task delivered to participants after baseline testing.
| Study group | Role | What they receive |
|---|---|---|
| Stress reactivity weight stigma | Experimental | This study arm received a stress reactivity paradigm that involved weight stigma content in the form of an evaluated speech task. Receives: Behavioral: Stress reactivity stimuli |
| Stress reactivity non-weight stigma. | Active comparator | This study arm received a stress reactivity paradigm that involved non-weight stigma content in the form of an evaluated speech task. Receives: Behavioral: Stress reactivity stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurotrophins - Brain-Derived Neurotrophic Factor (BDNF)
Changes in BDNF
Measured: Baseline (time 0; pre-stressor), Post-stressor (time 1; 30 minutes), Post-stressor (time 2; 60 minutes), Post-stressor (time 3; 90 minutes), ,
Neurotrophins - Glial-Derived Neurotrophic Factor (GDNF)
Changes in GDNF
Measured: Baseline (time 0; pre-stressor), Post-stressor (time 1; 30 minutes), Post-stressor (time 2; 60 minutes), Post-stressor (time 3; 90 minutes), ,
Secondary outcomes (1)
Inflammatory Panel - IL-6, IL-1beta, TNF-alpha, IFN-gamma
Changes in pro-inflammatory cytokines IL-6, IL-1beta, TNF-alpha, INF-gamma
Measured: Baseline (time 0; pre-stressor), Post-stressor (time 1; 30 minutes), Post-stressor (time 2; 60 minutes), Post-stressor (time 3; 90 minutes), ,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start4 Dec 2019
- Primary completion4 Aug 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misty Hawkins, PhD, Principal investigator, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076722
- Sponsor's protocol ID
- AS1965
- Acronym
- NICE SPACES
- Status last verified
- Mar 2021
- First submitted
- 24 Jul 2019
- Last updated
- 19 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurotrophic Indicators of Cognition, Executive Skills, Plasticity, and Adverse Childhood Experiences Study "NICE SPACES"
- ClinicalTrials.gov ID
- NCT04076722
- Acronym / sponsor ID
- NICE SPACES / AS1965
- Conditions
- Weight Loss, Wait-List Control
- Keywords
- Obesity, Weight Loss, Adverse childhood experiences, Executive function, Brain health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 4 Aug 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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). 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 (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 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 (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). 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress reactivity weight stigma | Experimental | Behavioral: Stress reactivity stimuliThis study arm received a stress reactivity paradigm that involved weight stigma content in the form of an evaluated speech task. |
| Stress reactivity non-weight stigma. | Active comparator | Behavioral: Stress reactivity stimuliThis study arm received a stress reactivity paradigm that involved non-weight stigma content in the form of an evaluated speech task. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- an overweight/obese body mass index (BMI = 25 kg/m2 or greater)
- English speaking
- No use of weight loss medications in the past 3 months,
- No history of or planning to undergo bariatric surgery during the study period,
- Not currently pregnant or breastfeeding or planning to become pregnant during the study period,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress reactivity stimuliAn evaluated speech task delivered to participants after baseline testing. | Behavioural | Stress reactivity non-weight stigma., Stress reactivity weight stigma |
Primary outcome
Neurotrophins - Brain-Derived Neurotrophic Factor (BDNF)
Time frame: Baseline (time 0; pre-stressor), Post-stressor (time 1; 30 minutes), Post-stressor (time 2; 60 minutes), Post-stressor (time 3; 90 minutes), ,
Changes in BDNF
Neurotrophins - Glial-Derived Neurotrophic Factor (GDNF)
Time frame: Baseline (time 0; pre-stressor), Post-stressor (time 1; 30 minutes), Post-stressor (time 2; 60 minutes), Post-stressor (time 3; 90 minutes), ,
Changes in GDNF
1 secondary outcome
Inflammatory Panel - IL-6, IL-1beta, TNF-alpha, IFN-gamma
Time frame: Baseline (time 0; pre-stressor), Post-stressor (time 1; 30 minutes), Post-stressor (time 2; 60 minutes), Post-stressor (time 3; 90 minutes), ,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Misty Hawkins, PhD principal investigator
Oklahoma State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress reactivity stimuli in people with Weight Loss and Wait-List Control, run by Oklahoma State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurotrophins - Brain-Derived Neurotrophic Factor (BDNF) (time frame: Baseline (time 0; pre-stressor), Post-stressor (time 1; 30 minutes), Post-stressor (time 2; 60 minutes), Post-stressor (time 3; 90 minutes), ,). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.