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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Chiropractic spinal adjustments
Life University
Marietta, Georgia, United States
Proportion of Potential Participants Who Are Eligible.
The number of adults attending the on-site screening who are eligible to participate, divided to the total number of adults attending the on-site screening. This assesses 'Eligibility'
Time frame: From lab arrival to completion of on-site screening (up to 15 minutes)
Proportion of Participants Complying With Pre-baseline Lifestyle Restrictions
The number of participants complying with 24hr and 3hr pre-baseline lifestyle restrictions, divided by the total number of participants. This assesses 'Compliance'.
Time frame: From start of lifestyle restriction window to lab arrival (up to 24 hours)
Proportion of Participants Able to Tolerate the Assessments
The number of participants able to complete baseline assessments as directed, divided by the total number of participants. This assesses 'Tolerability'.
Time frame: From enrollment to completion of baseline assessments (up to 2 hours)
Proportion of Participants Adhering to Their Prescribed Care Plan
The number of participants prescribed a chiropractic care plan that attended ≥80% of their chiropractic sessions, divided by the total number of participants prescribed a chiropractic care plan. This assesses 'Adherence'.
Time frame: From enrollment to end of treatment (up to 6 weeks)
Proportion of Participants Retained in the Study
Number of participants enrolled who attend the final assessment session, divided by the total number of participants enrolled. This assesses 'Retention'.
Time frame: From enrollment to end of treatment (up to 6 weeks)
Changes in COMPASS-31 Raw Scores
Changes in self-reported autonomic function per the Composite Autonomic Symptom Score (COMPASS-31) survey. The COMPASS-31 is a 31-item questionnaire that evaluates ANS functioning across 6 domains: 1) orthostatic intolerance (4-items), 2) vasomotor (3-items), 3) secretomotor (4-items), 4) gastrointestinal (12-items), 5) bladder (3-items), and 6) pupillomotor (5-items). The domains are weighted, and the sum of the weighted sub-scores yields a total raw score ranging from 0-100. Higher scores indicate greater autonomic dysfunction with total raw scores ≥20 suggested to reflect moderate-to-severe autonomic dysfunction.
Time frame: Baseline, 2 weeks, 6 weeks
Changes in PSS-10 T-scores
Changes in perceived stress levels per the 10-item NIH Toolbox Perceived Stress Scale (PSS-10). NIH Toolbox negative emotion measures utilize a 7-day recall period, 5-point Likert scales (e.g., 1=never, 2=almost never, 3=sometimes, 4=fairly often, 5=very often). Total raw scores can range from 10 to 50. Raw scores are converted to standardized uncorrected T-scores (mean=50, SD=10) using conversion tables available in the online scoring instructions (https://www.healthmeasures.net/). Higher scores indicate greater levels of perceived stress with T-scores ≥60 deemed 'potentially problematic'.
Time frame: Baseline, 2 weeks, 6 weeks
Changes in PROMIS-Cog 8 T-scores
Changes in self-reported cognitive function per the 8-item PROMIS Cognitive Function (PROMIS-Cog 8) survey. It uses a 7-day recall period and relevant 5-point Likert scales (e.g., 1=never, 2=rarely, 3=sometimes, 4=often, 5=always). Total raw scores can range from 8 to 40. Raw scores are converted to a standardized T-score (mean=50, SD=10) using conversion tables available in the scoring instructions at the PROMIS® website (https://www.healthmeasures.net/). Lower scores indicate greater functional impairment with standard benchmarks for mild (T-score = 40 to 45), moderate (T-score = 30 to 40), or severe (T-score \<30) impairment.
Time frame: Baseline, 2 weeks, 6 weeks
Changes in PROMIS-29 Subscale T-scores
Changes in self-reported health per the T-scored PROMIS-29 subscales (physical function, social participation, anxiety, depression, fatigue, sleep disturbance). It uses a 7-day recall period and relevant 5-point Likert scales (e.g., 1=never, 2=rarely, 3=sometimes, 4=often, 5=always).Total raw scores can range from 4 to 20. Raw subscale scores are converted to a standardized T-score (mean=50, SD=10) using conversion tables available in the scoring instructions at the PROMIS® website (https://www.healthmeasures.net/). Lower scores on physical function, and social participation subscales indicate greater functional impairment with standard benchmarks for mild (T-score = 40 to 45), moderate (T-score = 30 to 40), or severe (T-score \<30) impairment. Higher scores on the anxiety, depression, fatigue, and sleep disturbance subscales indicate greater severity of symptoms with standard benchmarks for mild (T-score = 55 to 60), moderate (T-score = 60 to 70), and severe (T-score \>70) symptoms.
Time frame: Baseline, 2 weeks, 6 weeks
Changes in PROMIS-29 Subscale Raw Scores
Change in self-reported pain levels per the raw scored PROMIS-29 subscales (pain intensity). This subscale uses a 7-day recall period and is a single item scored on a 1 (no pain) to 10 (worst pain imaginable) scale.
Time frame: Baseline, 2 weeks, 6 weeks
Changes in RMSSD
Changes in ECG-derived root mean square of successive differences (RMSSD) during rest, stress, and recovery. RMSSD is a time-domain heart rate variability (HRV) metric used to assess cardiac-related parasympathetic activity.
Time frame: Baseline, 2 weeks, 6 weeks
Changes in PEP
Changes in impedance cardiography (ICG)-derived pre-ejection period (PEP) during rest, stress, and recovery. PEP is a time-domain metric used to assess cardiac-related sympathetic activity.
Time frame: Baseline, 2 weeks, 6 weeks
Changes in sIgA
Changes in salivary-derived secretory immunoglobulin A (sIgA) levels at rest. Salivary-derived sIgA is a measure of mucosal immune function.
Time frame: Baseline, 2 weeks, 6 weeks
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