Free-Living Sleep, Food Intake, and Physical Activity in Night and Morning Shift Workers.

Objective: Shift work is associated with risk for adverse health outcomes including cardiovascular disease, type 2 diabetes, cancer, and obesity. Short sleep duration combined with disruptions to the circadian system may alter factors involved with the behavioral regulation of energy intake and expenditure. We aimed to determine how shift work affects sleep, food intake, and physical activity.Methods: This was a field-based observational study using objective assessments of sleep and physical activity and a 24-hour dietary recall in shift workers. Day (n = 12) and night (n = 12) hospital shift workers (nurses and technicians) who were women had their free-living sleep and physical activity tracked via accelerometry, and completed a computer-assisted 24-hour food recall, during a series of work shifts.Results: Compared to day workers, night workers had significantly shorter sleep duration and reported more premature awakenings and feeling less refreshed upon awakening. Daily self-reported energy and macronutrient intakes were not different between groups, although the night shift workers reported a significantly longer total daily eating duration window than day workers. Objectively recorded physical activity levels were not different between groups.Conclusions: The present findings confirm that sleep is disturbed in women night workers, while there are relatively less effects on objectively recorded physical activity and self-reported food intake. We also observed a prolonged daily eating duration in night vs. day workers. These observations can help inform the design of novel behavioral interventions, including, potentially, time restricted feeding approaches (e.g., by limiting daily eating episodes to within a 10-12 h window), to optimize weight management in shift workers.

Joint associations of occupational standing and occupational exertion with musculoskeletal symptoms in a US national sample.

OBJECTIVE: Observational studies have linked occupational standing or walking to musculoskeletal pain. These prior studies, however, are flawed as few accounted for physical exertion; a potential confounder that accompanies many standing-based occupations. The purpose of this study was to examine the individual and joint associations of occupational standing/walking and exertion with musculoskeletal symptoms. METHODS: Data for this analysis come from the 2015 National Health Interview Survey, a US nationally representative survey. Occupational standing/walking and exertion were assessed by self-report on a 5-point Likert scale. The presence of musculoskeletal symptoms (pain, aching and stiffness) for upper extremities (neck, shoulders, elbows, wrists and fingers), lower extremities (hips, knees, ankles and toes) and lower back was also assessed. RESULTS: Occupational standing/walking was associated with a greater likelihood of upper extremity, lower extremity and lower back musculoskeletal symptoms; however, associations were attenuated and no longer significant with adjustment for exertion. When stratified by levels of occupational exertion, occupational standing/walking was associated with musculoskeletal symptoms only among the group with high exertion (eg, OR=1.69 (95% CI: 1.48 to 1.94) for lower back symptoms comparing high/high for standing or walking/exertion vs low/low). Among groups with low exertion, occupational standing/walking was not associated with musculoskeletal symptoms (eg, OR=1.00 (95% CI: 0.85 to 1.16) for lower back symptoms comparing high/low for standing or walking/exertion vs low/low). CONCLUSION: Results from this US representative survey suggest that the association between occupational standing/walking and musculoskeletal symptoms is largely driven by the co-occurrence of occupational exertion and does not provide evidence that standing or walking incurs adverse musculoskeletal symptoms.

Occupational standing and change in the Ankle-Brachial Index: the Jackson Heart Study.

BACKGROUND: A growing interest in reducing occupational sitting has resulted in public health efforts to encourage intermittent standing in workplaces. However, concerns have been raised that standing for prolonged periods may expose individuals to new health hazards, including lower limb atherosclerosis. These concerns have yet to be corroborated or refuted. The purpose of this study was to investigate the association between occupational standing and adverse changes in the Ankle-Brachial Index (ABI). METHODS: We studied 2121 participants from the Jackson Heart Study, a single-site community-based study of African-Americans residing in Jackson, MS. Occupational standing ('never/seldom', 'sometimes', 'often/always') was self-reported at baseline (2000-2004). ABI was measured at baseline and again at follow-up (2009-2013). RESULTS: Over a median follow-up of 8 years, 247 participants (11.6%) exhibited a significant decline in ABI (eg, ABI decline >0.15). In multivariable-adjusted models, higher occupational standing was not significantly associated with ABI decline (occupational standing sometimes vs never/seldom: OR 1.05; 95% CI 0.67, 1.66; occupational standing often/always vs never/seldom: OR 1.22; 95% CI 0.77, 1.94). Similarly, higher occupational standing was not associated with low ABI at follow-up reflective of peripheral artery disease (ABI <0.90) or high ABI at follow-up reflective of incompressible vessels (ABI >1.40). CONCLUSIONS: In this community-based study of African-Americans, we found no evidence that occupational standing is deleteriously associated with adverse changes in ABI over a median follow-up of 8.0 years. These findings do not provide evidence implicating occupational standing as a risk factor for lower limb atherosclerosis.

An Examination of the Relationship Between Motivation, Physical Activity, and Wearable Activity Monitor Use.

Wearable physical activity (PA) monitors are widely promoted as a means to motivate people to be more active, but the motivational profile of users has never been assessed. This study's purpose was to classify adult users by their motivational regulation scores and examine how these profiles were associated with moderate to vigorous PA (MVPA). Current users (N = 320) recruited across the United States completed a Web-based survey. Motivational regulations were measured using the Behavioral Regulation in Exercise Questionnaire, and associations with MVPA were explored using bivariate correlations. MVPA was more highly correlated with autonomous rather than controlling regulations. A cluster analysis was conducted using the respondents' motivational regulation scores. Five motivational profiles emerged from this analysis, and they differed significantly across motivation and MVPA scores. PA monitor users characterized by more autonomous motives presented with higher MVPA. As technology use increases, assessing the multidimensionality of PA monitor users' motivation may add value when researching PA behaviors.

Acceptability and feasibility of a Fitbit physical activity monitor for endometrial cancer survivors.

OBJECTIVE: Endometrial cancer survivors are the least physically active of all cancer survivor groups and exhibit up to 70% obesity. While studies suggest lifestyle interventions result in improved health outcomes, recruitment and availability of these programs are limited. The purpose was to evaluate the acceptability and validity of the Fitbit Alta™ physical activity monitor (Fitbit) for socioculturally diverse endometrial cancer survivors. METHODS: Thirty endometrial cancer survivors were given wrist-worn Fitbits to wear for 30 days. Participants then returned the Fitbits, completed the Godin Leisure-Time Exercise Questionnaire (GLTEQ), Technology Acceptance Questionnaire, and answered qualitative prompts. Correlations between daily Fitbit step counts, demographic factors, body mass index (BMI), and GLTEQ Index, were analyzed using Stata 13.0. Concordance Correlation Coefficient using U statistics was used to examine convergent validity. RESULTS: Twenty-five participants completed the study. Mean age was 62 ±â€¯9 years. Mean BMI was 32 ±â€¯9 kg·m-2. Self-identified race/ethnicity was 36% Hispanic, 36% non-Hispanic white, 16% non-Hispanic black and 12% Asian. Participants wore the Fitbits a median of 93% of possible days. Median daily Fitbit step count was 5325 (IQR: 3761-8753). Mean Technology Acceptance score was 2.8 ±â€¯0.5 out of 4.0. Younger (<65 years) and employed participants were more likely to achieve at least 6000 daily steps (p < 0.05). There was no correlation (CCC = 0.00, p = 0.99) between step count and GLTEQ Index. Most free responses reflected positive experiences. CONCLUSIONS: The Fitbits were well accepted in this sample. Self-reported physical activity was not associated with steps recorded. The physical activity data indicate an insufficiently active population.

Physical Activity, Sleep, and Screen Time in Children and Adolescents Before and During the COVID-19 Pandemic: An Analysis of the 2019-2020 National Survey of Children's Health.

PURPOSE: The purpose of this study was to examine whether engagement in health behaviors changed from pre-pandemic (2019) to during the pandemic (2020). METHODS: The combined 2019-2020 National Survey of Children's Health (NSCH) was used to inform this study. The NSCH is an annual survey designed to provide national estimates of key indicators of childhood health and well-being. Physical activity (number of days/week with >60 min of activity), screen-time (hours/day of TV viewing and computer use), and sleep (hours/day) were assessed by parental report. Adjusted binomial and multinomial logistic regression models were used to determine the association between survey year and health behaviors. RESULTS: Children and adolescents were 36% more likely to be physically inactive in 2020 compared to 2019. Additionally, children and adolescents were 14% more likely to meet sleep guidelines and 39% less likely to meet screen-time guidelines in 2020 compared to 2019, independent of age, sex, race/ethnicity, and poverty level. Children (6-13 year) and adolescents (14-17 years) were 10% and 15% less likely to get below the recommended amount of sleep in 2020 compared to 2019, respectively. CONCLUSION: Prevalence of meeting sleep guidelines increased among children and adolescents in 2020 but decreased for physical activity and screen-time. Initiatives targeting activity and screen-time may be urgently needed. Whether rates of these health behaviors return to pre-pandemic levels over the next few years should be closely assessed.

Characterizing Heart Rate Variability Response to Maximal Exercise Testing in People with Huntington's Disease.

Background: Huntington's disease (HD) is an autosomal dominant, neurodegenerative disease that involves dysfunction in the autonomic nervous system (ANS). Heart rate variability (HRV) is a valid and noninvasive measure for ANS dysfunction, yet no study has characterized HRV response to exercise in people with HD. Objective: Characterize HRV response to exercise in individuals with HD and explore its implications for exercise prescription and cardiac dysautonomia mechanisms. Methods: 19 participants with HD were recruited as part of a cohort of individuals enrolled in the Physical Activity and Exercise Outcomes in Huntington's Disease (PACE-HD) study at Teachers College, Columbia University (TC). 13 non-HD age- and gender-matched control participants were also recruited from TC. HRV was recorded with a Polar H10 heart rate (HR) monitor before, during, and after a ramp cycle-ergometer exercise test. Results: Participants with HD showed reduced HR peak (p < 0.01) and HR reserve (p < 0.001) compared with controls. Participants with HD demonstrated reduced root mean square of successive differences between normal-to-normal intervals (RMSSD) and successive differences of normal-to-normal intervals (SDSD) at rest (p < 0.001). Participants with HD also showed differences for low frequency (LF) power (p < 0.01), high frequency (HF) normalized units (nu) (p < 0.05), LF (nu) (p < 0.001), and HF/LF ratio (p < 0.05) compared with controls. Conclusions: We found reduced aerobic exercise capacity and sympathovagal dysautonomia both at rest and during post-exercise recovery in people with HD, suggesting modified exercise prescription may be required for people with HD. Further investigations focusing on cardiac dysautonomia and underlying mechanisms of sympathovagal dysautonomia in people with HD are warranted.

Detection of Common Respiratory Infections, Including COVID-19, Using Consumer Wearable Devices in Health Care Workers: Prospective Model Validation Study.

BACKGROUND: The early detection of respiratory infections could improve responses against outbreaks. Wearable devices can provide insights into health and well-being using longitudinal physiological signals. OBJECTIVE: The purpose of this study was to prospectively evaluate the performance of a consumer wearable physiology-based respiratory infection detection algorithm in health care workers. METHODS: In this study, we evaluated the performance of a previously developed system to predict the presence of COVID-19 or other upper respiratory infections. The system generates real-time alerts using physiological signals recorded from a smartwatch. Resting heart rate, respiratory rate, and heart rate variability measured during the sleeping period were used for prediction. After baseline recordings, when participants received a notification from the system, they were required to undergo testing at a Northwell Health System site. Participants were asked to self-report any positive tests during the study. The accuracy of model prediction was evaluated using respiratory infection results (laboratory results or self-reports), and postnotification surveys were used to evaluate potential confounding factors. RESULTS: A total of 577 participants from Northwell Health in New York were enrolled in the study between January 6, 2022, and July 20, 2022. Of these, 470 successfully completed the study, 89 did not provide sufficient physiological data to receive any prediction from the model, and 18 dropped out. Out of the 470 participants who completed the study and wore the smartwatch as required for the 16-week study duration, the algorithm generated 665 positive alerts, of which 153 (23.0%) were not acted upon to undergo testing for respiratory viruses. Across the 512 instances of positive alerts that involved a respiratory viral panel test, 63 had confirmed respiratory infection results (ie, COVID-19 or other respiratory infections detected using a polymerase chain reaction or home test) and the remaining 449 had negative upper respiratory infection test results. Across all cases, the estimated false-positive rate based on predictions per day was 2%, and the positive-predictive value ranged from 4% to 10% in this specific population, with an observed incidence rate of 198 cases per week per 100,000. Detailed examination of questionnaires filled out after receiving a positive alert revealed that physical or emotional stress events, such as intense exercise, poor sleep, stress, and excessive alcohol consumption, could cause a false-positive result. CONCLUSIONS: The real-time alerting system provides advance warning on respiratory viral infections as well as other physical or emotional stress events that could lead to physiological signal changes. This study showed the potential of wearables with embedded alerting systems to provide information on wellness measures.

Breaking Up Prolonged Sitting to Improve Cardiometabolic Risk: Dose-Response Analysis of a Randomized Crossover Trial.

PURPOSE: Sedentary time is ubiquitous in developed nations and is associated with deleterious health outcomes. Physical activity guidelines recommend reductions in sedentary time; however, quantitative guidelines that inform how often and how long sedentary time should be interrupted have not been provided. The purpose of this study was to examine the acute effects of multiple doses of a sedentary break intervention on cardiometabolic risk factors, concurrently evaluating efficacy of varying frequencies and durations of sedentary breaks. METHODS: In a randomized crossover study, middle- and older-age adults ( n = 11) completed the following 8-h conditions on five separate days: 1 uninterrupted sedentary (control) condition and four acute (experimental) trials that entailed different sedentary break frequency/duration combinations: every 30 min for 1 min, every 30 min for 5 min, every 60 min for 1 min, and every 60 min for 5 min. Sedentary breaks entailed light-intensity walking. Glucose and blood pressure (BP) were measured every 15 and 60 min, respectively. RESULTS: Compared with control, glucose incremental area under the curve was significantly attenuated only for the every 30 min for 5-min dose (-11.8[4.7]; P = 0.017). All sedentary break doses yielded significant net decreases in systolic BP from baseline compared with control ( P < 0.05). The largest reductions in systolic BP were observed for the every 60 min for 1 min (-5.2 [1.4] mm Hg) and every 30 min for 5 min (-4.3[1.4] mm Hg) doses. CONCLUSIONS: The present study provides important information concerning efficacious sedentary break doses. Higher-frequency and longer-duration breaks (every 30 min for 5 min) should be considered when targeting glycemic responses, whereas lower doses may be sufficient for BP lowering.

Protocol of a feasibility study of a virtual personalized (N-of-1) trial for increasing low-intensity physical activity in older adults via habit formation.

Background: Personalized interventions that can be delivered remotely are needed to increase physical activity (PA) in older adults to reduce risk of CV disease and mortality. Prior research indicates that Behavioral Change Techniques (BCTs) (e.g., goal setting, self-monitoring, behavioral repetition) can instill a habit for increasing daily walking. However, past interventions relied on between-subject randomized clinical trials, which can only only be informative about response of the hypothetical average person. Personalized trial designs can identify the benefits of an intervention for a specific individual although extended periods are required for collecting frequent measurements within-subject. Advances in remote, virtual technologies (e.g., text messaging, activity trackers), integrated with automatic platforms, can meet these requirements because they capacitate delivery of BCT interventions, and collection of data during daily life without personal contact. This Stage I-b trial is designed test whether a virtual, personalized intervention is feasible and acceptable to older adults, can elicit participant adherence and exhibit preliminary evidence for efficacy. Methods: A series of up to 60 single-arm, personalized trials, involving no personal contact, will recruit adults, 45-75 years of age, to wear an activity tracker during a 2-week baseline and a 10-week intervention. Five BCT prompts to execute a walking plan will be delivered on a daily basis during the intervention phase. Participants will rate satisfaction with personalized trial components and whether automaticity of the walking plan can be achieved. Step-counts, adherence to the walking plan and self-monitoring of step-count will also be recorded.

Wearable activity monitors to support physical activity interventions in neurodegenerative disease: a feasibility study.

Aim: To evaluate the feasibility of using activity monitors in a physical activity (PA) intervention in people with Parkinson's (PD) and Huntington's disease (HD). Materials & methods: People with early-stage PD (n = 13) and HD (n = 14) enrolled in a 4-month coaching program, wore a Fitbit, and were guided through a behavioral intervention to facilitate PA uptake. Wear time, wear habits and activity metrics (e.g., steps) were analyzed. Results: Retention rate was 85% and participants had an average 92.3% (±9.2) valid wear days. Daily wear time was 18.4 (±4.5) h. Day & night Fitbit wearers showed improvements in steps (d = 1.02) and MET×min/week (d = 0.69) compared with day-only wearers. Conclusion: Implementing wearables in a coaching intervention was feasible and provided insights into PA behavior.

A Series of Personalized Virtual Light Therapy Interventions for Fatigue: Feasibility Randomized Crossover Trial for N-of-1 Treatment.

BACKGROUND: Fatigue is one of the most common symptoms treated in primary care and can lead to deficits in mental health and functioning. Light therapy can be an effective treatment for symptoms of fatigue; however, the feasibility, scalability, and individual-level heterogeneity of light therapy for fatigue are unknown. OBJECTIVE: This study aimed to evaluate the feasibility, acceptability, and effectiveness of a series of personalized (N-of-1) interventions for the virtual delivery of bright light (BL) therapy and dim light (DL) therapy versus usual care (UC) treatment for fatigue in 60 participants. METHODS: Participants completed satisfaction surveys comprising the System Usability Scale (SUS) and items assessing satisfaction with the components of the personalized trial. Symptoms of fatigue were measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) daily, PROMIS weekly, and ecological momentary assessment (EMA) questionnaires delivered 3 times daily. Comparisons of fatigue between the BL, DL, and UC treatment periods were conducted using generalized linear mixed model analyses between participants and generalized least squares analyses within individual participants. RESULTS: Participants rated the usability of the personalized trial as acceptable (average SUS score=78.9, SD 15.6), and 92% (49/53) of those who completed satisfaction surveys stated that they would recommend the trial to others. The levels of fatigue symptoms measured using the PROMIS daily fatigue measure were lower or improved in the BL (B=-1.63, 95% CI -2.63 to -0.63) and DL (B=-1.44, 95% CI -2.50 to -0.38) periods relative to UC. The treatment effects of BL and DL on the PROMIS daily measure varied among participants. Similar findings were demonstrated for the PROMIS weekly and EMA measures of fatigue symptoms. CONCLUSIONS: The participant scores on the SUS and satisfaction surveys suggest that personalized N-of-1 trials of light therapy for fatigue symptoms are both feasible and acceptable. Both interventions produced significant (P<.05) reductions in participant-reported PROMIS and EMA fatigue symptoms relative to UC. However, the heterogeneity of these treatment effects across participants indicated that the effect of light therapy was not uniform. This heterogeneity along with high ratings of usability and satisfaction support the use of personalized N-of-1 research designs in evaluating the effect of light therapy on fatigue for each patient. Furthermore, the results of this trial provide additional support for the use of a series of personalized N-of-1 research trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT04707846; https://clinicaltrials.gov/ct2/show/NCT04707846.

The effect of a multi-component behavior change technique intervention on medication adherence among individuals on primary prevention statin therapy: a dose-finding protocol.

BACKGROUND: In the USA, the primary cause of death and morbidity continues to be cardiovascular disease (CVD). Numerous trials have shown that statin medication reduces the likelihood of CVD events; it is a cornerstone of CVD prevention. However, studies have also indicated that up to 60% of the estimated 26.8 million Americans prescribed primary prevention statin treatment are nonadherent during the first year. Multi-component behavioral change technique (BCT) therapies have shown moderate promise in improving medication adherence as well as other positive health behaviors (such as physical activity). However, no research has looked at the duration of multi-component BCT intervention needed to result in a clinically significant improvement in statin adherence behaviors. This study aims to determine the necessary dose of a multi-component BCT intervention (defined as duration in weeks) to promote adherence to statin medication among those on primary prevention statin treatment by utilizing the modified time-to-event continuous reassessment method (TiTE-CRM). METHODS AND DESIGN: The study will utilize the modified TiTE-CRM in 42 participants, recruited in 14 cohorts of 3 participants each. The goal of this analysis is to identify the minimum effective dose (MED) of a multi-behavior change technique (BCT) intervention required to increase adherence to statins by 20% between baseline and follow-up periods. Using the TiTE-CRM method, the dose of the behavior intervention in weeks will be assigned to each cohort based on the performance of the prior cohort. At the end of the study, the intervention dose that has been found to be associated with a 20% increase in statin adherence among 80% of participants assigned to that dose will be identified as the MED. DISCUSSION: If successful, the current trial will provide additional guidance to researchers and clinicians seeking to increase statin medication adherence using a BCT intervention by identifying the dose (i.e., the duration) of an intervention required to meaningfully increase adherence. TRIAL REGISTRATION: ClinicalTrials.gov NCT05273736. Registered on March 10, 2022. https://www. CLINICALTRIALS: gov/ct2/show/NCT05273736.

Testing Behavior Change Techniques to Increase Physical Activity in Middle-Aged and Older Adults: Protocol for a Randomized Personalized Trial Series.

BACKGROUND: Being physically active is critical to successful aging, but most middle-aged and older adults do not move enough. Research has shown that even small increases in activity can have a significant impact on risk reduction and improve quality of life. Some behavior change techniques (BCTs) can increase activity, but prior studies on their effectiveness have primarily tested them in between-subjects trials and in aggregate. These design approaches, while robust, fail to identify those BCTs most influential for a given individual. In contrast, a personalized, or N-of-1, trial design can assess a person's response to each specific intervention. OBJECTIVE: This study is designed to test the feasibility, acceptability, and preliminary effectiveness of a remotely delivered personalized behavioral intervention to increase low-intensity physical activity (ie, walking) in adults aged 45 to 75 years. METHODS: The intervention will be administered over 10 weeks, starting with a 2-week baseline period followed by 4 BCTs (goal-setting, self-monitoring, feedback, and action planning) delivered one at a time, each for 2 weeks. In total, 60 participants will be randomized post baseline to 1 of 24 intervention sequences. Physical activity will be continuously measured by a wearable activity tracker, and intervention components and outcome measures will be delivered and collected by email, SMS text messages, and surveys. The effect of the overall intervention on step counts relative to baseline will be examined using generalized linear mixed models with an autoregressive model that accounts for possible autocorrelation and linear trends for daily steps across time. Participant satisfaction with the study components and attitudes and opinions toward personalized trials will be measured at the intervention's conclusion. RESULTS: Pooled change in daily step count will be reported between baseline and individual BCTs and baseline versus overall intervention. Self-efficacy scores will be compared between baseline and individual BCTs and between baseline and the overall intervention. Mean and SD will be reported for survey measures (participant satisfaction with study components and attitudes and opinions toward personalized trials). CONCLUSIONS: Assessing the feasibility and acceptability of delivering a personalized, remote physical activity intervention for middle-aged and older adults will inform what steps will be needed to scale up to a fully powered and within-subjects experimental design remotely. Examining the effect of each BCT in isolation will allow for their unique impact to be assessed and support design of future behavioral interventions. In using a personalized trial design, the heterogeneity of individual responses for each BCT can be quantified and inform later National Institutes of Health stages of intervention development trials. TRIAL REGISTRATION: clinicaltrials.gov NCT04967313; https://clinicaltrials.gov/ct2/show/NCT04967313. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/43418.

The effect of a multi-component behavior change technique intervention on physical activity among individuals on primary prevention statin therapy: A dose-finding trial protocol.

BACKGROUND: Statin therapy is a mainstay of cardiovascular disease (CVD) prevention, but research shows that statin therapy alone is insufficient for preventing incident CVD and mortality. Combining statin medication with increased physical activity (PA) can lower mortality risk more than either statin or PA alone. However, PA levels often remain the same and may even decline following statin prescription. Additional information is needed to identify how to increase PA among statin users and determine the minimal length of an intervention (i.e., intervention dose) necessary to increase PA. OBJECTIVE: The study aims to identify the required dose of a behavior change technique (BCT) intervention to increase PA among individuals on primary prevention statin therapy who have an elevated risk for cardiovascular disease (CVD). METHODS: The study will utilize the modified time-to-event continual reassessment method (TiTE-CRM) in 42 participants. We expect insights relating to dose-efficacy models and BCTs (Behavior Change Techniques) to improve PA in adults at risk for CVD. This trial will also examine potential mechanisms of action (MoAs) for interventions to increase PA, identify any effect a PA intervention may have on medication adherence, and determine whether participants respond uniformly to their respective behavioral interventions. ETHICS AND DISSEMINATION: This trial was approved by the Northwell Health Institutional Review Board (IRB) and all participants will complete informed consent. The trial results will be published in a peer-reviewed journal. All publications resulting from this series of personalized trials will follow the CONSORT reporting guidelines. REGISTRATION DETAILS: This trial is registered on www. CLINICALTRIALS: gov (Number NCT05273723).

Feasibility Test of Personalized (N-of-1) Trials for Increasing Middle-Aged and Older Adults' Physical Activity.

Purpose: To test the feasibility of a remotely-delivered intervention to increase low-intensity physical activity (walking) in middle-aged and older adults. Design: This study used a Personalized (N-of-1) trial design. Setting: This study took place at a major healthcare system from November 2021 to February 2022. Subjects: Sixty adults (45-75 years, 92% female, 80% white) were recruited. Intervention: A 10-week study comprising a 2-week baseline, followed by four 2-week periods where 4 Behavior Change Techniques (BCTs) - self-monitoring, goal setting, action planning and feedback - were delivered one at a time in random order. Measures: Activity was measured by a Fitbit, and intervention components delivered by email/text. Average daily steps were compared between baseline and intervention. Participants completed satisfaction items derived from the System Usability Scale and reported attitudes and opinions about personalized trials. Results: Participants rated personalized trial components as feasible and acceptable. Changes in steps between baseline and intervention were not significant, but a large heterogeneity of treatment effects existed, suggesting some participants significantly increased walking while others significantly decreased. Conclusions: Our intervention was well-accepted but use of BCTs delivered individually did not result in a significant increase in steps. Feasibility and heterogeneity of treatment effects support adopting a personalized trial approach to optimize intervention results.

Changes in Health Behaviors Associated With Weight Gain by Weight Classification During the COVID-19 Pandemic.

PURPOSE: To determine whether perceived changes (i.e. perception of engagement during the pandemic relative to pre-pandemic) in specific health behaviors differ by weight status (i.e. healthy weight, overweight, obese). DESIGN: Cross-sectional. Recruitment took place between June-August 2020, via social media posts and Qualtrics online panels. SETTING: Participants completed the survey online through the Qualtrics platform. SAMPLE: Analyses included N = 502 participants (≥18 years); 45.2% healthy weight (n = 227), 28.5% overweight (n = 143), and 26.3% obese (n = 132). MEASURES: Study-specific survey items included questions about demographics and perceived changes in health behaviors. ANALYSIS: Logistic regression models, adjusted for age, race, ethnicity, gender, education, and COVID-19 diagnosis, assessed the odds of perceiving changes in health behaviors considered a risk for weight gain. RESULTS: Participants with obesity, but not overweight, were significantly more likely to report deleterious changes to health behaviors compared to healthy weight peers, including: (1) decreased fruit/vegetable consumption [adjusted odds ratio (AOR) = 1.92; 95% confidence interval (CI): (1.13, 3.26)]; (2) increased processed food consumption [AOR = 1.85; 95%CI: (1.15, 3.00)]; (3) increased caloric intake [AOR = 1.66; 95% CI: (1.06, 2.61)]; (4) decreased physical activity [AOR = 2.07; 95%CI: (1.31, 3.28)]; and (5) deterioration in sleep quality [AOR = 2.07; 95%CI: (1.32, 3.25)]. CONCLUSION: Our findings suggest that adults with obesity may be at greater risk for unhealthy behaviors during a period of prolonged social distancing, potentially exacerbating the obesity epidemic.

Perception of moderate-intensity physical activity by onset of obesity: A randomized crossover trial.

Moderate-intensity physical activity is recommended for inactive adults with overweight/obesity (OW/OB). The objective of this study is to determine if differences exist in the selection of moderate intensity between inactive adults with juvenile-onset (JO) and adult-onset (AO) OW/OB. Participants (JO = 18, AO = 20) were stratified by onset and completed two separate 20-minute moderate-intensity exercise sessions on a treadmill and cycle ergometer (randomized order). Multiple linear regression was used to determine whether exercise intensity (average METS, % age-predicted HRmax ), self-reported pleasure or exertion differed by onset, controlling for age and gender. On the treadmill, JO and AO participants selected an average intensity of (mean [SD]) 3.5 (0.9) and 3.7 (0.9) METS, and 64.0 (7.7) and 64.9 (7.5) % of age-predicted HRmax , respectively. On the cycle, JO and AO participants selected an average intensity of 3.3 (0.9) and 3.3 (1.0) METS, and 65.2 (8.8) and 60.7 (7.2) % of age-predicted HRmax . After adjustment, participant intensity selection did not significantly differ by obesity onset when walking or cycling. There were no significant differences in pleasure or perceived exertion by onset, however, perception of exertion was on the high-end of moderate for both the cycle (13.0, 12.5) and treadmill (12.0, 12.1), in JO and AO participants, respectively. Perception of moderate intensity did not differ by obesity onset. Self-selected intensity was at the low end of moderate for walking and cycling.

Introducing Data Sciences to N-of-1 Designs, Statistics, Use-Cases, the Future, and the Moniker 'N-of-1' Trial.

This article, an introduction to HDSR's "Personalized (N-of-1) Trials: Methods, Applications, and Impact" special issue, describes the rationale for a primer of the methods, data types and management, designs, and use cases for personalized (N-of-1) trials. It explains that the design and implementation of personalized (N-of-1) trials is only useful if patients volunteer for research involving them and actively participate in clinical services that use them. However, 'N-of-1 trials' may be an inadequate name to enact such patient engagement. The authors briefly review what patients have reported about the 'N-of-1' label and propose a more consumer-friendly moniker for this type of research and clinical approach to improve evidence-based science.

A qualitative examination of apathy and physical activity in Huntington's and Parkinson's disease.

Aim: In Huntington's disease (HD) and Parkinson's disease (PD), apathy is a frequently cited barrier to participation in physical activity. Current diagnostic criteria emphasize dissociable variants of apathy that differentially affect goal-directed behavior. How these dimensions present and affect physical activity in HD and PD is unknown. Methods: Using a qualitative approach, we examined the experience of apathy and its impact on physical activity in 20 people with early-manifest HD or idiopathic PD. Results: Two major themes emerged: the multidimensionality of apathy, including initiation or goal-identification difficulties, and the interplay of apathy and fatigue; and facilitators of physical activity, including routines, safe environments and education. Conclusion: Physical activity interventions tailored to apathy phenotypes may maximize participant engagement.