Wellness Program Participation and Changes in Health and Quality of Life in Adults and Children

Condition(s) studied

Study summary

The goal of this observational study is to learn how health and quality of life change over time in adults and children aged 2 years and older. It will also examine how these changes are related to participation in wellness activities and the use of nutritional supplements.

The main questions this study aims to answer are:

How do measures of health, physical function, and quality of life change over time? Are changes in these measures associated with participation in a wellness program, nutritional supplement use, or other health and lifestyle factors?

Participants may:

Answer questions about their health, lifestyle, physical activity, sleep, fatigue, stress, and quality of life.

Complete physical and functional assessments. Choose to provide blood samples for laboratory testing. Complete follow-up assessments over time.

This is an observational study. Researchers will not assign participants to a wellness program or any other intervention or tell participants which supplements to use. Any wellness program participation or supplement use occurs independently of the study.

Eligibility

Primary outcome measure(s)

• Change from baseline in N100 amplitude measured using the NeuroCatch Platform — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in N100 event-related potential (ERP) amplitude, measured in microvolts (µV) using the NeuroCatch portable electroencephalography (EEG) platform. N100 amplitude represents the magnitude of the electrophysiological response associated with early auditory sensory processing.
• Change from baseline in N100 latency measured using the NeuroCatch Platform — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in N100 ERP latency, measured in milliseconds (ms) using the NeuroCatch portable EEG platform. N100 latency represents the timing of the electrophysiological response associated with early auditory sensory processing.
• Change from baseline in P300 amplitude measured using the NeuroCatch Platform — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in P300 ERP amplitude, measured in microvolts (µV) using the NeuroCatch portable EEG platform. P300 amplitude represents the magnitude of the electrophysiological response associated with attentional and orienting processing.
• Change from baseline in P300 latency measured using the NeuroCatch Platform — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in P300 ERP latency, measured in milliseconds (ms) using the NeuroCatch portable EEG platform. P300 latency represents the timing of the electrophysiological response associated with attentional processing.
• Change from baseline in N400 amplitude measured using the NeuroCatch Platform — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in N400 ERP amplitude, measured in microvolts (µV) using the NeuroCatch portable EEG platform. N400 amplitude represents the magnitude of the electrophysiological response associated with higher-order semantic processing.
• Change from baseline in N400 latency measured using the NeuroCatch Platform — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in N400 ERP latency, measured in milliseconds (ms) using the NeuroCatch portable EEG platform. N400 latency represents the timing of the electrophysiological response associated with higher-order semantic processing.
• Change From Baseline in Heart Rate Recovery Assessed by Electrocardiography — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in heart rate recovery following a standardized physiological challenge will be assessed using electrocardiography (ECG). Heart rate recovery will be calculated as the difference between the heart rate at the end of the challenge and the heart rate measured at a prespecified recovery time point (1 minute) after cessation of the challenge. Heart rate recovery will be reported in beats per minute (bpm). A larger decrease in heart rate during the recovery period indicates faster cardiac autonomic recovery.
• Change From Baseline in Body Composition as Measured by the InBody Bioelectrical Impedance Analysis (BIA) System — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in body composition will be assessed using an InBody bioelectrical impedance analysis (BIA) device. Body composition parameters will include percent body fat (%), body fat mass (kg), and skeletal muscle mass (kg). Changes in each parameter will be calculated as the value at the follow-up assessment minus the corresponding baseline value, expressed as a percentage.
• Change From Baseline in Forced Expiratory Volume in One Second to Forced Vital Capacity (FEV1/FVC) Ratio as Measured by Spirometry — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in the ratio of Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FEV1/FVC) will be assessed using spirometry. The FEV1/FVC ratio represents the proportion of the total forced vital capacity that is exhaled during the first second of a forced expiratory maneuver and will be expressed as a percentage. Change will be calculated as the follow-up FEV1/FVC value minus the corresponding baseline value and will be expressed as a percentage in relation to the baseline.
• Change From Baseline in Hand Grip Strength as Measured by a Handgrip Dynamometer — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in hand grip strength will be assessed using a handgrip dynamometer and reported in kilograms (kg). Hand grip strength represents the maximal voluntary isometric force generated during a handgrip contraction. Grip strength will be measured in both the right and left hands. The highest valid grip-strength measurement from three attempts for each hand will be identified. Overall hand grip strength will be calculated as the average of the best right-hand and best left-hand measurements. This averaged value, expressed in kg, will constitute the reported hand grip strength for each assessment. Change from baseline will be calculated as the follow-up overall hand grip strength value minus the baseline overall hand grip strength value and will be expressed as a percentage in relation to the baseline. A positive change indicates increased grip strength, while a negative change indicates decreased grip strength.
• Change From Baseline in Timed Up and Go (TUG) — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in functional mobility as assessed using the Timed Up and Go test.
• Change From Baseline in Dynamic Gait Index — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in gait and balance as assessed using the Dynamic Gait Index.
• Change From Baseline in Symbol Digit Modalities Test — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in cognitive performance as assessed using the Symbol Digit Modalities Test.
• Change From Baseline in Distance Visual Acuity as Measured Using a Snellen Visual Acuity Chart — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in distance visual acuity will be assessed using a Snellen visual acuity chart. Visual acuity represents the ability to distinguish letters or symbols at a standardized testing distance and will be recorded as a Snellen fraction (e.g., 20/20). Visual acuity will be assessed according to the study's standardized vision assessment protocol. Change from baseline will be determined by comparing the follow-up visual acuity measurement with the corresponding baseline measurement.
• Change From Baseline in Total Physical Activity as Assessed by the International Physical Activity Questionnaire - Short Form (IPAQ-SF) — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in total physical activity will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The questionnaire assesses self-reported physical activity performed during the previous 7 days, including walking, moderate-intensity activity, and vigorous-intensity activity. Physical activity will be summarized as total Metabolic Equivalent of Task minutes per week (MET-minutes/week) according to the standardized IPAQ scoring protocol. Total physical activity is calculated from the reported frequency and duration of walking, moderate-intensity activity, and vigorous-intensity activity, weighted by their corresponding MET values. Higher MET-minutes/week indicate a greater level of physical activity and are generally considered a more favorable outcome in the context of this wellness study. Change from baseline will be calculated as the follow-up total physical activity score in MET-minutes/week minus the corresponding baseline score.
• Change From Baseline in Simple Lifestyle Indicator Questionnaire (SLIQ) Score — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in the Simple Lifestyle Indicator Questionnaire (SLIQ) overall score. The SLIQ is a 12-item questionnaire that assesses five lifestyle domains: diet, physical activity, alcohol consumption, smoking, and stress. The overall SLIQ score ranges from 0 to 10, with higher scores indicating a healthier lifestyle. A positive change from baseline indicates improvement in overall lifestyle.
• Change From Baseline in Fatigue Severity Scale (FSS) Score — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in the Fatigue Severity Scale (FSS) score. The FSS is a 9-item self-reported questionnaire that assesses the severity of fatigue and its impact on daily functioning. Each item is rated on a 7-point scale from 1 (strongly disagree) to 7 (strongly agree). The overall FSS score is calculated as the mean of the nine item scores and ranges from 1 to 7. Higher scores indicate greater fatigue severity and therefore a worse outcome. A negative change from baseline indicates an improvement in fatigue severity.
• Change From Baseline in 10-Item Perceived Stress Scale (PSS-10) Score — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in the 10-Item Perceived Stress Scale (PSS-10) score. The PSS-10 is a 10-item self-reported questionnaire that assesses the degree to which situations in an individual's life are perceived as stressful. Each item is rated on a 5-point scale from 0 (never) to 4 (very often), with positively worded items reverse scored. Item scores are summed to produce a total score ranging from 0 to 40. Higher scores indicate greater perceived stress and therefore a worse outcome. A negative change from baseline indicates an improvement (reduction) in perceived stress.
• Change From Baseline in Participant-Reported Outcomes Measurement Information System (PROMIS) Global Health v1.2 (PROMIS-10) Scores — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in the Participant-Reported Outcomes Measurement Information System (PROMIS) Global Health v1.2 (PROMIS-10) scores. The PROMIS-10 is a 10-item patient-reported questionnaire assessing global physical, mental, and social health. The measure provides separate Global Physical Health and Global Mental Health summary scores. For each summary domain, the raw summed score ranges from 4 to 20 and is converted to a standardized T-score. Global Physical Health T-scores range from 16.2 to 67.7, and Global Mental Health T-scores range from 21.2 to 67.6. Higher T-scores indicate better physical or mental health and therefore a better outcome. A positive change from baseline indicates improvement in global health.
• Change From Baseline in World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) Domain Scores — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in the World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) domain scores. The WHOQOL-BREF is a 26-item self-reported questionnaire that assesses quality of life across four domains: Physical Health, Psychological Health, Social Relationships, and Environment. Domain scores are transformed to a 0 to 100 scale, with higher scores indicating better quality of life and therefore a better outcome. A positive change from baseline indicates an improvement in quality of life.
• Change From Baseline in Quality of Life in Neurological Disorders (Neuro-QoL) Cognitive Function Score (Short form) — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in the Quality of Life in Neurological Disorders (Neuro-QoL) Short Form Cognitive Function score. The Neuro-QoL Cognitive Function measure is a patient-reported assessment of perceived cognitive abilities, including areas such as memory, attention, concentration, and executive functioning. Responses are converted to standardized T-scores, with a reference population mean of 50 and a standard deviation of 10. The minimum and maximum attainable T-scores for short form Neuro-QoL Cognitive Function are 17.3 and 64.2. Higher T-scores indicate better perceived cognitive function and therefore a better outcome. A positive change from baseline indicates improvement in cognitive function.
• Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score — Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.
  Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) global score. The PSQI is a 19-item self-reported questionnaire that assesses sleep quality and sleep disturbances over the past month across seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored from 0 to 3, and the seven component scores are summed to produce a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality and therefore a worse outcome. A negative change from baseline indicates improvement in overall sleep quality.

Trial sites (2)