Abdominal Obesity
Conditions
Keywords
abdominal obesity, adults, psychoneuroimmunology, chiropractic
Brief summary
Since 1980, the global prevalence of obesity, commonly defined as a body mass index (BMI) of 30 or higher, has doubled. Importantly, high levels of central adiposity (i.e., abdominal fat) is associated with numerous PNI-related sequelae, including increased levels of psychological distress, cognitive deficits, ANS dysfunction, and immune marker abnormalities. To our knowledge, rigorous investigation of chiropractic's impact on psychoneuroimmunological (PNI)-related outcomes in people with high central adiposity is lacking. Based on limited evidence to date, it is plausible that clinically important PNI-related dysfunctions (e.g., heightened stress levels, executive function impairments, dysautonomia, immune dysregulation) common in this population could be ameliorated via chiropractic care.
Detailed description
Up to twenty (20) obese individuals (18-65 yrs of age) will be recruited. For our trial, obesity will be indexed as a BMI ≥30 and an elevated waist circumference (i.e., \>35 inches for women, \>40 inches for men). Subjects will be asked to do the following… * Restrict certain behaviors prior to their lab visits which include 1) 3 hours prior abstain from caffeine, brushing your teeth, alcohol-based mouthwash, nicotine, food, & drinking large amounts of liquid very quickly (e.g., chugging a 16 oz bottle of water; sipping water is ok) and 2) 24 hours prior abstain from strenuous exercise, alcohol, & over the counter drugs (e.g., antihistamines, Tylenol, etc.) * Have their height, weight, and waist circumference measured. * Drool into a tube for subsequent testing of immune markers (i.e., salivary IgA) * Have electrodes placed on/around their chest & back to measure respiration, ECG, and impedance cardiography (ICG) * Perform a postural challenge whereby they lay supine (8 min), stand quickly (3 min), and return quickly to the supine position (3 min). * Have their cognitive function assessed while walking on a treadmill (dual task). * Answer questions about their mental, physical, and emotional health. * Receive 6-weeks of chiropractic adjustments from community-based clinicians. Assessments will take place at baseline, after 2 weeks of chiropractic, and after 6 weeks of chiropractic.
Interventions
PROCEDUREChiropractic
Chiropractic spinal adjustments
Sponsors
University of Georgia
Life University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18-65 years of age * Body mass index (BMI) at least 30 * Waist circumference at least 35 inches if female or 40 inches if male
Exclusion criteria
* Had chiropractic care within the past 30 days * Prescribed short-acting benzodiazepines which include midazolam & triazolam * If taking prescription medications, other than short-acting benzodiazepines, not on a stable dose for a minimum of 6 weeks with plans to change medications or doses during the study * Not able to walk unassisted on a treadmill * Known disorder resulting in syncope/fainting during postural changes (e.g., POTS, orthostatic hypotension) * Pacemaker or known heart condition that influences the electrical or mechanical function of the heart (e.g., severe heart valve disease) * Diagnosed with externalizing (e.g., substance use, antisocial disorder) or thought (e.g., schizophrenia, paranoid personality, bipolar) disorder that is uncontrolled or untreated * Diagnosed with rheumatoid arthritis, osteoporosis, or cervical spine instability * Hearing impairment (cognitive task uses auditory stimuli) * Currently pregnant * Current litigation related to a physical, health-related injury * Whiplash injury in the past 3 months * Oral injury, inflammation, or disease that causes the mouth or gums to bleed easily
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Data quality | 6 weeks | % of acquisitions from a given assessment that are suitable for analysis |
| Recruitment | up to 6 months | Average number of participants recruited/enrolled per month |
| Efficiency | 6 weeks | Average battery duration |
| Latency | 6 weeks | Average time between first lab assessment & first chiropractic session |
| Compliance | 6 weeks | proportion of participants complying with pre-assessment lifestyle restrictions |
| Adherence | 6 weeks | proportion of participants attending ≥80% of their chiropractic sessions |
| Tolerability | 6 weeks | % of participants able to complete a given assessment |
| Retention | 6 weeks | proportion of participants completing the trial |
| Acceptability | 6 weeks | proportion of participant-rated & clinician-rated acceptability scores ≥3 in each domain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Flexibility | 6 weeks | Modulation of executive function (i.e., cognitive flexibility) as indicated by changes in auditory switch task reaction time and decision error rate during gait |
| Gait | 6 weeks | Modulation of gait as indicated by changes in the percentage of time spent in stance phase, load response, swing phase, single support, pre-swing, and initial swing. |
| Heart rate variability | 6 weeks | Modulation of electrocardiography (ECG)-derived heart rate variability (HRV) during rest, stress, and recovery. |
| Pre-ejection period | 6 weeks | Modulation of impedance cardiography (ICG)-derived pre-ejection period (PEP) during rest, stress, and recovery. |
| Secretory IgA | 6 weeks | Modulation of immune activity as indicated by changes in salivary derived secretory immunoglobulin A (sIgA) levels at rest. |
| COMPASS-31 | 6 weeks | Changes in self-reported autonomic function per the COMPASS-31 survey |
| PROMIS-29 | 6 weeks | Changes in self-reported health related quality of life per the PROMIS-29 survey |
| PROMIS-Cog 8 | 6 weeks | Changes in self-reported cognitive function per the PROMIS-Cognitive 8 survey |
| Perceived Stress Scale | 6 weeks | Changes in self-reported stress per the Perceived Stress Scale (PSS). |
Countries
United States
Outcome results
None listed