Neurotrophic Indicators of Cognition, Executive Skills, Plasticity, and Adverse Childhood Experiences Study

NCT04076722 | Completed

• 1 other identifier: AS1965
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Weight Loss; Wait-List Control

Keywords

Obesity; Weight Loss; Adverse childhood experiences; Executive function; Brain health

Outcome Measures

Primary Outcomes (2)

• Neurotrophins - Brain-Derived Neurotrophic Factor (BDNF)

  Changes in BDNF

  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

  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

  Baseline (time 0; pre-stressor), Post-stressor (time 1; 30 minutes), Post-stressor (time 2; 60 minutes), Post-stressor (time 3; 90 minutes), ,

Study Arms (2)

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.

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.

Behavioral: Stress reactivity stimuli

Interventions

Stress reactivity stimuli BEHAVIORAL

An evaluated speech task delivered to participants after baseline testing.

Stress reactivity non-weight stigma.; Stress reactivity weight stigma

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Individuals must be biologically female to be eligible for the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ®),
• 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

Sponsors & Collaborators

• Oklahoma State University: lead

Study Sites (1)

Oklahoma State University

Stillwater, Oklahoma, 74078, United States

Location

MeSH Terms

Conditions

Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Misty Hawkins, PhD

  Oklahoma State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study condition (weight stigma vs. not stigma) was contained in a blinded envelope that only the confederate had access to. The PI does not know which condition the participant got. And the outcomes assessors did not know the condition.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: September 3, 2019
• Study Start: December 4, 2019
• Primary Completion: August 4, 2020
• Study Completion: December 11, 2020
• Last Updated: March 19, 2021

Record last verified: 2021-03

Locations

US (1)