Measuring intra-individual physical activity variability using consumer-grade activity devices.

Many existing sedentary behavior and physical activity studies focus on primary outcomes that assess change by comparing participants' activity from baseline to post-intervention. With the widespread availability of consumer-grade devices that track activity daily, researchers do not need to rely on those endpoint measurements alone. Using activity trackers, researchers can collect remote data about the process of behavior change and future maintenance of the change by measuring participants' intra-individual physical activity variability. Measuring intra-individual physical activity variability can enable researchers to create tailored and dynamic interventions that account for different physical activity behavior change trajectories, and by that, improve participants' program adherence, enhance intervention design and management, and advance interventions measurements' reliability. We propose an application of intra-individual physical activity variability as a measurement and provide three use cases within interventions. Intra-individual physical activity variability can be used: prior to the intervention period, where relationships between participants' intra-individual physical activity variability and individual characteristics can be used to predict adherence and subsequently tailor interventions; during the intervention period, to assess progress and subsequently boost interventions; and after the intervention, to obtain a reliable representation of the change in primary outcome.

To Text or Not to Text: Electronic Message Intervention to Improve Treatment Adherence Versus Matched Historical Controls.

BACKGROUND: Ensuring treatment adherence is important for the internal validity of clinical trials. In intervention studies where touch points decrease over time, there is even more of an adherence challenge. Trials with multiple cohorts offer an opportunity to innovate on ways to increase treatment adherence without compromising the integrity of the study design, and previous cohorts can serve as historical controls. Electronically delivered nudges offer low-cost opportunities to increase treatment adherence. OBJECTIVE: This study aimed to evaluate the effectiveness of electronic messages (e-messages) on treatment adherence to the last cohort of a parent weight loss intervention during the second half of a year-long trial, when intervention checkpoint frequency decreases. Treatment adherence is measured by intervention class attendance and adherence to the intervention diet. METHODS: All participants in the last cohort (cohort 5, n=128) of a large randomized weight loss study were offered an e-message intervention to improve participant adherence during the last 6 months of a 1-year weight loss program. Overall, 3 to 4 electronic weekly messages asked participants about intervention diet adherence. A propensity score model was estimated using 97 participants who opted to receive e-messages and 31 who declined in cohort 5 and used to pair match cohort 5 e-message participants to a historical control group from cohorts 1 to 4. Moreover, 88 participants had complete data, yielding 176 participants in the final analyses. After matching, intervention and matched control groups were compared on (1) proportion of class attendance between the 6 and 12 month study endpoints, (2) diet adherence, as measured by total carbohydrate grams for low-carbohydrate (LC) and total fat grams for low-fat (LF) diets at 12 months, and (3) weight change from 6 to 12 months. The dose-response relationship between the proportion of text messages responded to and the 3 outcomes was also investigated. RESULTS: Compared with matched controls, receiving e-messages had no effect on (1) treatment adherence; class attendance after 6 months +4.6% (95% CI -4.43 to 13.68, P=.31), (2) adherence; LC -2.5 g carbohydrate, 95% CI -29.9 to 24.8, P=.85; LF +6.2 g fat, 95% CI -4.1 to 17.0, P=.26); or on (3) the secondary outcome of weight change in the last 6 months; +0.3 kg (95% CI -1.0 to 1.5, P=.68). There was a positive significant response correlation between the percentage of messages to which participants responded and class attendance (r=.45, P<.001). CONCLUSIONS: Although this e-message intervention did not improve treatment adherence, future studies can learn from this pilot and may incorporate more variety in the prompts and more interaction to promote more effective user engagement. Uniquely, this study demonstrated the potential for innovating within a multicohort trial using propensity score-matched historical control subjects. TRIAL REGISTRATION: ClinicalTrials.gov NCT01826591; https://clinicaltrials.gov/ct2/show/NCT01826591. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1016/j.cct.2016.12.021.

Effects of a methodological infographic on research participants' knowledge, transparency, and trust.

OBJECTIVE: Given participants' research literacy is essential for clinical trial participation, evidence-based strategies are needed that improve literacy and easily accessed online. We tested whether an infographic letter-that illustrated how dropouts can distort study conclusions-improved participant knowledge about the impact of dropouts relative to a control letter. METHOD: In three distinct online samples purposely recruited to assess reproducibility, young ethnically diverse adults were randomized to read an infographic letter or control letter in a hypothetical scenario. Secondary outcomes included participants' perceived transparency of the research organization, perceived value of retention, and perceived trust of the organization. We purposely included two discriminant items, perceived value for the trial outcome and keeping commitments in general, both hypothesized not to change. RESULTS: Across samples, ∼20% more infographic participants correctly answered how dropouts affected study conclusions than control participants. For example (Experiment 3), nearly 90% of infographic participants correctly answered versus only two thirds of controls (88.7% vs. 66.7%, absolute percentage difference 22.0%, p < .0001). Infographic participants had substantially higher transparency, perceived value for retention, and trust (Cohen's ds = 0.4-1.0, ps < .0001), yet importantly did not value the study outcome or report keeping commitments more than control participants (Cohen's ds = 0.0-0.1, ps > .10). CONCLUSIONS: Promisingly, this transparent, visually powerful methodological infographic improved knowledge and trust. Future trials could embed and experimentally test whether such low-cost online infographics improve not only research literacy, but also trial retention, especially among populations with less initial trust about research. (PsycINFO Database Record

Health-related quality of life among veterans in addictions treatment: identifying behavioral targets for future intervention.

BACKGROUND: US veterans report lower health-related quality of life (HRQoL) relative to the general population. Identifying behavioral factors related to HRQoL that are malleable to change may inform interventions to improve well-being in this vulnerable group. PURPOSE: The current study sought to characterize HRQoL in a largely male sample of veterans in addictions treatment, both in relation to US norms and in association with five recommended health behavior practices: regularly exercising, managing stress, having good sleep hygiene, consuming fruits and vegetables, and being tobacco free. METHODS: We assessed HRQoL with 250 veterans in addictions treatment (96 % male, mean age 53, range 24-77) using scales from four validated measures. Data reduction methods identified two principal components reflecting physical and mental HRQoL. Model testing of HRQoL associations with health behaviors adjusted for relevant demographic and treatment-related covariates. RESULTS: Compared to US norms, the sample had lower HRQoL scores. Better psychological HRQoL was associated with higher subjective social standing, absence of pain or trauma, lower alcohol severity, and monotonically with the sum of health behaviors (all p < 0.05). Specifically, psychological HRQoL was associated with regular exercise, stress management, and sleep hygiene. Regular exercise also related to better physical HRQoL. The models explained >40 % of the variance in HRQoL. CONCLUSIONS: Exercise, sleep hygiene, and stress management are strongly associated with HRQoL among veterans in addictions treatment. Future research is needed to test the effect of interventions for improving well-being in this high-risk group.

The Influence of Exercise Environment and Gender on Mood and Exertion.

This study examined the influence of exercise environment and gender on post-exercise mood and exertion. College student participants (55 females, 49 males) were instructed to pedal a stationary bike at a moderate pace for 20 minutes. Participants were randomly assigned to one of three laboratory conditions: (1) exercising in front of a mirror and posters showing ideal fit body types (i.e., celebrity male and female personal trainers), (2) exercising in front of a mirror only, or (3) a control condition in which participants exercised without a mirror or posters. The Activation-Deactivation Adjective Check List (AD-ACL), measuring exercise-induced mood states, was administered both before and after exercise. Average bike speed throughout the exercise session measured exertion. Mirrors and posters of ideally fit celebrities did interact with gender on post-exercise tension in that women felt most tense after exercising in front of the mirror and posters while men were most tense after exercising in front of the mirror only. Exercise exertion was also impacted by experimental condition such that participants rode significantly faster in the mirror and posters condition. There was no significant interaction of gender and condition on exercise exertion, but women pedaled fastest in the mirror and poster condition relative to the other conditions. Results suggest that exercise exertion and tension reduction are partially a by-product of gender and exercise environment.