Trial Outcomes & Findings for The Effects of Chiropractic in a Population With High Central Adiposity (NCT NCT06208163)

Recruitment began on November 11, 2024, and ended on September 4, 2025. Participants were recruited via word of mouth, flyers, social media posts, trial registries, and newspaper advertisements.

The Effects of Chiropractic in a Population With High Central Adiposity

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'

The number of participants complying with 24hr and 3hr pre-baseline lifestyle restrictions, divided by the total number of participants. This assesses 'Compliance'.

The number of participants able to complete baseline assessments as directed, divided by the total number of participants. This assesses 'Tolerability'.

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'.

Number of participants enrolled who attend the final assessment session, divided by the total number of participants enrolled. This assesses 'Retention'.

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.

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'.

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.

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.

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.

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.

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.

Changes in salivary-derived secretory immunoglobulin A (sIgA) levels at rest. Salivary-derived sIgA is a measure of mucosal immune function.