The Digital Therapeutics Real-World Evidence Framework: An Approach for Guiding Evidence-Based Digital Therapeutics Design, Development, Testing, and Monitoring.

Digital therapeutics (DTx) are a promising way to provide safe, effective, accessible, sustainable, scalable, and equitable approaches to advance individual and population health. However, developing and deploying DTx is inherently complex in that DTx includes multiple interacting components, such as tools to support activities like medication adherence, health behavior goal-setting or self-monitoring, and algorithms that adapt the provision of these according to individual needs that may change over time. While myriad frameworks exist for different phases of DTx development, no single framework exists to guide evidence production for DTx across its full life cycle, from initial DTx development to long-term use. To fill this gap, we propose the DTx real-world evidence (RWE) framework as a pragmatic, iterative, milestone-driven approach for developing DTx. The DTx RWE framework is derived from the 4-phase development model used for behavioral interventions, but it includes key adaptations that are specific to the unique characteristics of DTx. To ensure the highest level of fidelity to the needs of users, the framework also incorporates real-world data (RWD) across the entire life cycle of DTx development and use. The DTx RWE framework is intended for any group interested in developing and deploying DTx in real-world contexts, including those in industry, health care, public health, and academia. Moreover, entities that fund research that supports the development of DTx and agencies that regulate DTx might find the DTx RWE framework useful as they endeavor to improve how DTxcan advance individual and population health.

Recommendations for Identifying Valid Wear for Consumer-Level Wrist-Worn Activity Trackers and Acceptability of Extended Device Deployment in Children.

BACKGROUND: Self-reported physical activity is often inaccurate. Wearable devices utilizing multiple sensors are now widespread. The aim of this study was to determine acceptability of Fitbit Charge HR for children and their families, and to determine best practices for processing its objective data. METHODS: Data were collected via Fitbit Charge HR continuously over the course of 3 weeks. Questionnaires were given to each child and their parent/guardian to determine the perceived usability of the device. Patterns of data were evaluated and best practice inclusion criteria recommended. RESULTS: Best practices were established to extract, filter, and process data to evaluate device wear, r and establish minimum wear time to evaluate behavioral patterns. This resulted in usable data available from 137 (89%) of the sample. CONCLUSIONS: Activity trackers are highly acceptable in the target population and can provide objective data over longer periods of wear. Best practice inclusion protocols that reflect physical activity in youth are provided.

Modelling multiple health behavior change with network analyses: results from a one-year study conducted among overweight and obese adults.

This study examined the between-person associations of seven health behaviors in adults with obesity participating in a weight loss intervention, as well as the covariations between these behaviors within-individuals across the intervention. The present study included data from a 12-month weight loss trial (N = 278). Seven health behaviors (physical activity, sedentary behavior, sleep duration, and consumption of fruits, vegetables, total fat and added sugar) were measured at baseline, 6- and 12-months. Between- and within-participants network analyses were conducted to examine how these behaviors were associated through the 12-month intervention and covaried across months. At the between-participants level, associations were found within the different diet behaviors and between total fat and sedentary behaviors. At the within-participants level, covariations were found between sedentary and diet behaviors, and within diet behaviors. Findings suggest that successful multiple health behaviors change interventions among adults with obesity will need to (1) simultaneously target sedentary and diet behaviors; and (2) prevent potential compensatory behaviors in the diet domain.

Text messaging and brief phone calls for weight loss in overweight and obese English- and Spanish-speaking adults: A 1-year, parallel-group, randomized controlled trial.

BACKGROUND: Weight loss interventions based solely on text messaging (short message service [SMS]) have been shown to be modestly effective for short periods of time and in some populations, but limited evidence is available for positive longer-term outcomes and for efficacy in Hispanic populations. Also, little is known about the comparative efficacy of weight loss interventions that use SMS coupled with brief, technology-mediated contact with health coaches, an important issue when considering the scalability and cost of interventions. We examined the efficacy of a 1-year intervention designed to reduce weight among overweight and obese English- and Spanish-speaking adults via SMS alone (ConTxt) or in combination with brief, monthly health-coaching calls. ConTxt offered 2-4 SMS/day that were personalized, tailored, and interactive. Content was theory- and evidence-based and focused on reducing energy intake and increasing energy expenditure. Monthly health-coaching calls (5-10 minutes' duration) focused on goal-setting, identifying barriers to achieving goals, and self-monitoring. METHODS AND FINDINGS: English- and Spanish-speaking adults were recruited from October 2011 to March 2013. A total of 298 overweight (body mass index [BMI] 27.0 to 39.9 kg/m2) adults (aged 21-60 years; 77% female; 41% Hispanic; 21% primarily Spanish speaking; 44% college graduates or higher; 22% unemployed) were randomly assigned (1:1) to receive either ConTxt only (n = 101), ConTxt plus health-coaching calls (n = 96), or standard print materials on weight reduction (control group, n = 101). We used computer-based permuted-block randomization with block sizes of three or six, stratified by sex and Spanish-speaking status. Participants, study staff, and investigators were masked until the intervention was assigned. The primary outcome was objectively measured percent of weight loss from baseline at 12 months. Differences between groups were evaluated using linear mixed-effects regression within an intention-to-treat framework. A total of 261 (87.2%) and 253 (84.9%) participants completed 6- and 12-month visits, respectively. Loss to follow-up did not differ by study group. Mean (95% confidence intervals [CIs]) percent weight loss at 12 months was -0.61 (-1.99 to 0.77) in the control group, -1.68 (-3.08 to -0.27) in ConTxt only, and -3.63 (-5.05 to -2.81) in ConTxt plus health-coaching calls. At 12 months, mean (95% CI) percent weight loss, adjusted for baseline BMI, was significantly different between ConTxt plus health-coaching calls and the control group (-3.0 [-4.99 to -1.04], p = 0.003) but not between the ConTxt-only and the control group (-1.07 [-3.05 to 0.92], p = 0.291). Differences between ConTxt plus health-coaching calls and ConTxt only were not significant (-1.95 [-3.96 to 0.06], p = 0.057). These findings were consistent across other weight-related secondary outcomes, including changes in absolute weight, BMI, and percent body fat at 12 months. Exploratory subgroup analyses suggested that Spanish speakers responded more favorably to ConTxt plus health-coaching calls than English speakers (Spanish contrast: -7.90 [-11.94 to -3.86], p < 0.001; English contrast: -1.82 [-4.03 to 0.39], p = 0.107). Limitations include the unblinded delivery of the intervention and recruitment of a predominantly female sample from a single site. CONCLUSIONS: A 1-year intervention that delivered theory- and evidence-based weight loss content via daily personalized, tailored, and interactive SMS was most effective when combined with brief, monthly phone calls. TRIAL REGISTRATION: ClinicalTrials.gov NCT01171586.

Associations between reliable changes in depression and changes in BMI, total body fatness and visceral adiposity during a 12-month weight loss trial.

We investigated associations between changes in depression and body composition over a 12-month weight loss trial. Of the 298 adults (BMI > 27 m/kg2), 219 with complete depression and body composition data were included. A 10-item Center for Epidemiologic Studies Depression Scale measured depression; dual-energy X-ray absorptiometry measured body composition. Multinomial logistic regression predicted reliable changes in depression by BMI, body fat (BF) and visceral adiposity (VAT). Multiplicative interaction terms tested modification by sex and ethnicity. Participants with increases in body composition were less likely to experience improvements in depression (BMI: RRR = 0.79 (0.68-0.91), p < 0.01; BF: RRR = 0.97 (0.94 - 0.99), p = 0.01; VAT: RRR = 0.99 (0.98-1.00), p = 0.02), but not worsening of depression (BMI: RRR = 1.29 (0.96-1.73), p = 0.10; BF: RRR = 1.04 (0.99-1.09), p = 0.15; VAT: RRR = 1.01 (1.00-1.03), p = 0.18). Sex and ethnicity interaction terms were not significant. However, the relationship was only significant among females, among non-Latinos for BMI and BF, and among Latinos for VAT. Our study supports the association between depression and obesity and highlights the need for longitudinal studies investigating VAT and depression in diverse ethnic groups.

Planned care for obesity and cardiovascular risk reduction using a stepped-down approach: A randomized-controlled trial.

Primary care-based approaches to address concurrent obesity and cardiovascular disease risk factors (CVDRFs) that begin with a high intensity intervention that is subsequently decreased (i.e., stepped-down) if weight loss is achieved have not been rigorously examined. Our study is a 20-month, single-blind randomized controlled trial at five primary care clinics in San Diego, CA, in 2013, where 262 obese adults (aged 25-70 years; 32.1% male; 59.2% white) with at least one CVDRF were enrolled into planned care for obesity and risk reduction (PCORR) using a stepped-down approach or enhanced usual care (EUC). All patients received physician recommendations for weight loss and CVDRFs. EUC patients (n = 132) received an individual session with a health educator every 4 months. PCORR patients (n = 130) received individual and group sessions (in-person, mail, telephone, and email) in three steps, characterized by less contact if success was achieved. At 20 months, 40.7%, 23.8%, and 15.4% of PCORR patients were in steps 1, 2, and 3, respectively (25.2% were lost to follow-up). PCORR resulted in a between-group difference in reduction in body weight of 6.1% [95% CI, 5.3 to 6.9] compared to EUC 2.8% [95% CI, 2.0 to 3.6] p = 0.007, with a greater reduction in BMI (35.2 [95% CI, 34.4 to 35.9] to 33.7 [95% CI, 32.9 to 34.5] kg/m2) than EUC (36.0 [95% CI, 35.3 to 36.8] to 35.1 [95% CI, 34.3 to 35.9] kg/m2), as indicated by a significant treatment by time interaction (p = 0.009). PCORR resulted in greater weight loss over 20 months than EUC. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01134029.

Face-to-Face and Online Networks: College Students' Experiences in a Weight-Loss Trial.

This study aimed to understand how college students participating in a 2-year randomized controlled trial (Project SMART: Social and Mobile Approach to Reduce Weight; N = 404) engaged their social networks and used social and mobile technologies to try and lose weight. Participants in the present study (n = 20 treatment, n = 18 control) were approached after a measurement visit and administered semi-structured interviews. Interviews were analyzed using principles from grounded theory. Treatment group participants appreciated the timely support provided by the study and the integration of content across multiple technologies. Participants in both groups reported using non-study-designed apps to help them lose weight, and many participants knew one another outside of the study. Individuals talked about weight-loss goals with their friends face to face and felt accountable to follow through with their intentions. Although seeing others' success online motivated many, there was a range of perceived acceptability in talking about personal health-related information on social media. The findings from this qualitative study can inform intervention trials using social and mobile technologies to promote weight loss. For example, weight-loss trials should measure participants' use of direct-to-consumer technologies and interconnectivity so that treatment effects can be isolated and cross-contamination accounted for.

Developing and Evaluating Digital Interventions to Promote Behavior Change in Health and Health Care: Recommendations Resulting From an International Workshop.

Devices and programs using digital technology to foster or support behavior change (digital interventions) are increasingly ubiquitous, being adopted for use in patient diagnosis and treatment, self-management of chronic diseases, and in primary prevention. They have been heralded as potentially revolutionizing the ways in which individuals can monitor and improve their health behaviors and health care by improving outcomes, reducing costs, and improving the patient experience. However, we are still mainly in the age of promise rather than delivery. Developing and evaluating these digital interventions presents new challenges and new versions of old challenges that require use of improved and perhaps entirely new methods for research and evaluation. This article discusses these challenges and provides recommendations aimed at accelerating the rate of progress in digital behavior intervention research and practice. Areas addressed include intervention development in a rapidly changing technological landscape, promoting user engagement, advancing the underpinning science and theory, evaluating effectiveness and cost-effectiveness, and addressing issues of regulatory, ethical, and information governance. This article is the result of a two-day international workshop on how to create, evaluate, and implement effective digital interventions in relation to health behaviors. It was held in London in September 2015 and was supported by the United Kingdom's Medical Research Council (MRC), the National Institute for Health Research (NIHR), the Methodology Research Programme (PI Susan Michie), and the Robert Wood Johnson Foundation of the United States (PI Kevin Patrick). Important recommendations to manage the rapid pace of change include considering using emerging techniques from data science, machine learning, and Bayesian approaches and learning from other disciplines including computer science and engineering. With regard to assessing and promoting engagement, a key conclusion was that sustained engagement is not always required and that for each intervention it is useful to establish what constitutes "effective engagement," that is, sufficient engagement to achieve the intended outcomes. The potential of digital interventions for testing and advancing theories of behavior change by generating ecologically valid, real-time objective data was recognized. Evaluations should include all phases of the development cycle, designed for generalizability, and consider new experimental designs to make the best use of rich data streams. Future health economics analyses need to recognize and model the complex and potentially far-reaching costs and benefits of digital interventions. In terms of governance, developers of digital behavior interventions should comply with existing regulatory frameworks, but with consideration for emerging standards around information governance, ethics, and interoperability.

Reimagining Human Research Protections for 21st Century Science.

BACKGROUND: Evolving research practices and new forms of research enabled by technological advances require a redesigned research oversight system that respects and protects human research participants. OBJECTIVE: Our objective was to generate creative ideas for redesigning our current human research oversight system. METHODS: A total of 11 researchers and institutional review board (IRB) professionals participated in a January 2015 design thinking workshop to develop ideas for redesigning the IRB system. RESULTS: Ideas in 5 major domains were generated. The areas of focus were (1) improving the consent form and process, (2) empowering researchers to protect their participants, (3) creating a system to learn from mistakes, (4) improving IRB efficiency, and (5) facilitating review of research that leverages technological advances. CONCLUSIONS: We describe the impetus for and results of a design thinking workshop to reimagine a human research protections system that is responsive to 21st century science.

Influence of specific individual and environmental variables on the relationship between body mass index and health-related quality of life in overweight and obese adolescents.

PURPOSE: Overweight and obese adolescents are at risk for low health-related quality of life (HRQOL). We examined the role of individual- and environmental-level variables on the relationship between body mass index (BMI kg/m(2)) and HRQOL in adolescents. METHODS: Linear regressions were performed to conduct mediation and moderation analyses on the relationship between BMI and HRQOL in overweight and obese adolescents (N = 205). HRQOL was measured by the Pediatric Quality of Life Inventory. Hypothesized mediators included depression, measured by the Center for Epidemiologic Studies Depression Scale; body image, measured by the gender-specific body dissatisfaction subscale of the Eating Disorder Inventory; and self-esteem, measured by the Rosenberg Self-Esteem Scale. Mediation was assessed using Baron and Kenny's approach and Sobel's test of indirect effects. Anglo-acculturation, measured by the Short Acculturation Scale for Hispanics-Youth, and environmental perception, measured by parent-proxy report of the Neighborhood Environment Walkability Scale, were hypothesized moderators. RESULTS: Body image mediated the relationship between BMI and HRQOL (b = -0.34, SE = 0.17, adj R (2) = 0.19, p = .051), and self-esteem was a partial mediator (b = -0.37, SE = 0.17, adj R (2) = 0.24, p = .027). Sobel's test confirmed these results (p < .05). No significant moderation effects were found. CONCLUSIONS: The finding that individual-level factors, such as body image and self-esteem, influence the relationship between BMI and HRQOL while environmental factors, such as neighborhood environment and acculturation, do not extends previous research. The finding that body image and self-esteem partially mediate this relationship presents new areas to investigate in interventions that address BMI in youth.

Fit4Life: a weight loss intervention for children who have survived childhood leukemia.

BACKGROUND: Children surviving acute lymphoblastic leukemia (ALL) are at increased risk for overweight and obesity over that of the general population. Whether a generic or tailored approach to weight management is needed for cancer survivors has yet to be tested. PROCEDURE: Thirty-eight youth 8-18 years with BMI ≥ 85% who had survived ALL were recruited for a randomized clinical trial evaluating a weight management intervention (WMI) tailored for childhood ALL survivors (Fit4Life). Fit4Life recipients received a 4-month web, phone, and text message-delivered WMI tailored for cancer survivorship. Controls received a general WMI delivered via phone and mail. Assessments were performed at baseline and 4 months. Outcome data were analyzed according to assigned treatment condition over time. RESULTS: Most (80%, (70%, 100%) [median (IQR)]) of the assigned curriculum was received by Fit4Life participants as compared to 50% (40%, 65%) among controls. Fit4Life recipients ≥ 14 years demonstrated less weight gain (P = 0.05) and increased moderate-to-vigorous physical activity (P < 0.01) while all Fit4Life recipients reported reduced negative mood (P < 0.05) over time as compared to control counterparts. CONCLUSIONS: We demonstrated acceptable feasibility of a WMI tailored for overweight and obese children surviving ALL utilizing a multimodal technology approach. Improved weight, weight-related behavior, and psychological outcomes were demonstrated among Fit4Life intervention as compared to youth receiving a generic WMI. Data from this pilot trial may be used to design a larger trial to determine whether youth of all ages also can derive a benefit from a cancer survivor-tailored WMI and whether short-term outcomes translate into improved long-term outcomes for childhood ALL survivors.

Drinking a hot blood meal elicits a protective heat shock response in mosquitoes.

The mosquito's body temperature increases dramatically when it takes a blood meal from a warm-blooded, vertebrate host. By using the yellow fever mosquito, Aedes aegypti, we demonstrate that this boost in temperature following a blood meal prompts the synthesis of heat shock protein 70 (Hsp70). This response, elicited by the temperature of the blood meal, is most robust in the mosquito's midgut. When RNA interference is used to suppress expression of hsp70, protein digestion of the blood meal is impaired, leading to production of fewer eggs. We propose that Hsp70 protects the mosquito midgut from the temperature stress incurred by drinking a hot blood meal. Similar increases in hsp70 were documented immediately after blood feeding in two other mosquitoes (Culex pipiens and Anopheles gambiae) and the bed bug, Cimex lectularius, suggesting that this is a common protective response in blood-feeding arthropods.

Correlates of measured prehypertension and hypertension in Latina women living along the US-Mexico border, 2007-2009.

INTRODUCTION: Although Latinos have lower hypertension rates than non-Latino whites and African Americans, they have a higher prevalence of undiagnosed and uncontrolled hypertension. Research on predictors of hypertension has mostly focused on intrapersonal factors with no studies assessing the combined influence of intrapersonal, interpersonal, and environmental factors. The purpose of this study was to assess a broad range of correlates including intrapersonal, interpersonal, and environmental factors on measured blood pressure category (nonhypertensive, prehypertensive, and hypertensive) in a sample of Latina women residing in San Diego, California. METHODS: This cross-sectional study used baseline data from the San Diego Prevention Research Center's Familias Sanas y Activas program, a promotora-led physical activity intervention. The sample was 331 Latinas who self-selected into this program. Backward conditional logistic regression analysis was conducted to determine the strongest correlates of measured blood pressure category. RESULTS: Logistic regression analysis suggested that the strongest correlates of prehypertension were soda consumption (odds ratio [OR] = 1.34, [1.00-1.80], P ≤ .05) and age (OR = 1.03, [1.00-1.05], P ≤ .05). The strongest correlates of hypertension were soda consumption (OR = 1.92, [1.20-3.07], P ≤ .01), age (OR = 1.09, [1.05-1.13], P ≤ .001), and measured body mass index (OR = 1.13, [1.05-1.22], P ≤ .001). All analyses controlled for age and education. No interpersonal or environmental correlates were significantly associated with blood pressure category. CONCLUSION: Future research should aim to further understand the role of soda consumption on risk for hypertension in this population. Furthermore, interventions aimed at preventing hypertension may want to focus on intrapersonal level factors.

Click "like" to change your behavior: a mixed methods study of college students' exposure to and engagement with Facebook content designed for weight loss.

BACKGROUND: Overweight or obesity is prevalent among college students and many gain weight during this time. Traditional face-to-face weight loss interventions have not worked well in this population. Facebook is an attractive tool for delivering weight loss interventions for college students because of its popularity, potential to deliver strategies found in successful weight loss interventions, and ability to support ongoing adaptation of intervention content. OBJECTIVE: The objective of this study was to describe participant exposure to a Facebook page designed to deliver content to overweight/obese college students in a weight loss randomized controlled trial (N=404) and examine participant engagement with behavior change campaigns for weight loss delivered via Facebook. METHODS: The basis of the intervention campaign model were 5 self-regulatory techniques: intention formation, action planning, feedback, goal review, and self-monitoring. Participants were encouraged to engage their existing social network to meet their weight loss goals. A health coach moderated the page and modified content based on usage patterns and user feedback. Quantitative analyses were conducted at the Facebook post- and participant-level of analysis. Participant engagement was quantified by Facebook post type (eg, status update) and interaction (eg, like) and stratified by weight loss campaign (sequenced vs nonsequenced). A subset of participants were interviewed to evaluate the presence of passive online engagement or "lurking." RESULTS: The health coach posted 1816 unique messages to the study's Facebook page over 21 months, averaging 3.45 posts per day (SD 1.96, range 1-13). In all, 72.96% (1325/1816) of the posts were interacted with at least once (eg, liked). Of these, approximately 24.75% (328/1325) had 1-2 interactions, 23.39% (310/1325) had 3-5 interactions, 25.13% (333/1325) had 6-8 interactions, and 41 posts had 20 or more interactions (3.09%, 41/1325). There was significant variability among quantifiable (ie, visible) engagement. Of 199 participants in the final intervention sample, 32 (16.1%) were highly active users and 62 (31.2%) never visibly engaged with the intervention on Facebook. Polls were the most popular type of post followed by photos, with 97.5% (79/81) and 80.3% (386/481) interacted with at least once. Participants visibly engaged less with posts over time (partial r=-.33; P<.001). Approximately 40% of the participants interviewed (12/29, 41%) reported passively engaging with the Facebook posts by reading but not visibly interacting with them. CONCLUSIONS: Facebook can be used to remotely deliver weight loss intervention content to college students with the help of a health coach who can iteratively tailor content and interact with participants. However, visible engagement with the study's Facebook page was highly variable and declined over time. Whether the level of observed engagement is meaningful in terms of influencing changes in weight behaviors and outcomes will be evaluated at the completion of the overall study.

Physical Therapists' Acceptance of a Wearable, Fabric-Based Sensor System (Motion Tape) for Use in Clinical Practice: Qualitative Focus Group Study.

BACKGROUND: Low back pain (LBP) is a costly global health condition that affects individuals of all ages and genders. Physical therapy (PT) is a commonly used and effective intervention for the management of LBP and incorporates movement assessment and therapeutic exercise. A newly developed wearable, fabric-based sensor system, Motion Tape, uses novel sensing and data modeling to measure lumbar spine movements unobtrusively and thus offers potential benefits when used in conjunction with PT. However, physical therapists' acceptance of Motion Tape remains unexplored. OBJECTIVE: The primary aim of this research study was to evaluate physical therapists' acceptance of Motion Tape to be used for the management of LBP. The secondary aim was to explore physical therapists' recommendations for future device development. METHODS: Licensed physical therapists from the American Physical Therapy Association Academy of Leadership Technology Special Interest Group participated in this study. Overall, 2 focus groups (FGs; N=8) were conducted, in which participants were presented with Motion Tape samples and examples of app data output on a poster. Informed by the Technology Acceptance Model, we conducted semistructured FGs and explored the wearability, usefulness, and ease of use of and suggestions for improvements in Motion Tape for PT management of LBP. FG data were transcribed and analyzed using rapid qualitative analysis. RESULTS: Regarding wearability, participants perceived that Motion Tape would be able to adhere for several days, with some variability owing to external factors. Feedback was positive for the low-profile and universal fit, but discomfort owing to wires and potential friction with clothing was of concern. Other concerns included difficulty with self-application and potential skin sensitivity. Regarding usefulness, participants expressed that Motion Tape would enhance the efficiency and specificity of assessments and treatment. Regarding ease of use, participants stated that the app would be easy, but data management and challenges with interpretation were of concern. Physical therapists provided several recommendations for future design improvements including having a wireless system or removable wires, customizable sizes for the tape, and output including range of motion data and summary graphs and adding app features that consider patient input and context. CONCLUSIONS: Several themes related to Motion Tape's wearability, usefulness, and ease of use were identified. Overall, physical therapists expressed acceptance of Motion Tape's potential for assessing and monitoring low back posture and movement, both within and outside clinical settings. Participants expressed that Motion Tape would be a valuable tool for the personalized treatment of LBP but highlighted several future improvements needed for Motion Tape to be used in practice.

Fruit and vegetable intake and eating behaviors mediate the effect of a randomized text-message based weight loss program.

INTRODUCTION: We hypothesized that fruit/vegetable intake and eating behaviors mediate the relationship between experimental condition and weight loss in a randomized trial evaluating a text-message based weight loss program. METHODS: Overweight/obese individuals from San Diego, CA (N = 52 with complete data) were randomly assigned in 2007 into one of two groups for four months: 1) the intervention group that received 2-5 weight management text-messages p/day; 2) the usual-care comparison group. Three 24-hour recalls assessed fruit/vegetable intake change and the eating behavior inventory (EBI) measured change in eating behaviors. Regression path models tested intervention mediation. RESULTS: Direct effects of the intervention were found for change in body weight (b = -3.84, R(2) = 0.074), fruit/vegetable intake (b = 2.00, R(2) = 0.083), and EBI scores (b = 7.15, R(2) = 0.229) (ps < 0.05). The treatment group to weight change path was not statistically significant (b = -0.673, R(2) = 0.208) when fruit/vegetable intake change and EBI score change were specified as intervention mediators in the model. The total indirect effect was 3.17 lb indicating that the indirect paths explained 82.6% of the total effect on weight change. DISCUSSION: Fruit/vegetable intake and eating behaviors mediated the intervention's effect on weight change. The findings suggest that sending text-messages that promote healthy eating strategies resulted in moderate short-term weight loss.

Longitudinal measurement invariance of psychosocial measures in physical activity research: An application to adolescent data.

The current study served as a practical and substantive guide to establishing longitudinal measurement invariance of psychosocial measures commonly used in adolescent physical activity (PA) research. Psychosocial data on an initial sample of 878 adolescents (ages 11 - 15) recruited through primary care providers were provided at baseline, 6, 12, and 24 months. The target measures included family support, peer support, decisional balance (pros, cons), self-efficacy, and behavioral strategies. Five of the six psychosocial measures exhibited strict longitudinal measurement invariance, with the 6th measure (self-efficacy) exhibiting strong longitudinal measurement invariance. These findings support the equivalence of these measures across time, and provide the foundation to substantively interpret group differences and associations involving these measures and PA.

Community health partnerships for chronic disease prevention among Latinos: the San Diego Prevention Research Center.

Over 20 years ago, university-community partnerships (i.e., Prevention Research Centers [PRCs]) across the United States were funded by the Centers for Disease Control and Prevention to conduct research and training in order to promote health and prevent disease in underserved populations. In 2004, the San Diego PRC (SDPRC) became the first PRC to focus on obesity prevention and control in a community of mostly Mexican Americans/Mexican immigrants. The SDPRC was also the first PRC to comprise a university-community partnership with a school of public health, a school of medicine, and a federally qualified health center. In conjunction with two additional funded community partners and involvement of a community advisory board, the SDPRC seeks to develop effective intervention strategies that ultimately lead to behavior change. Now in its second cycle of funding, the SDPRC has identified three primary principles that are important for these and similar efforts: (1) developing culturally appropriate interventions requires community engagement; (2) building the evidence in a systematic and rigorous way yields meaningful strategies for translation to practice; and (3) translating evidence-based interventions to practice involves capacity building for both researchers and community partners. This article describes these principles to help others involved in similar intervention efforts identify the best approach for promoting health in their own communities.

The Independent Walking for Brain Health Intervention for Older Adults: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Extensive research suggests that physical activity (PA) is important for brain and cognitive health and may help to delay or prevent Alzheimer's disease and related dementias. Most PA interventions designed to improve brain health in older adults have been conducted in laboratory, gym, or group settings that require extensive resources and travel to the study site or group sessions. Research is needed to develop novel interventions that leverage mobile health (mHealth) technologies to help older adults increase their engagement in PA in free-living environments, reducing participant burden and increasing generalizability of research findings. Moreover, promoting engagement in moderate-to-vigorous PA (MVPA) may be most beneficial to brain health; thus, using mHealth to help older adults increase time spent in MVPA in free-living environments may help to offset the burden of Alzheimer's disease and related dementias and improve quality of life in older age. OBJECTIVE: We developed a novel PA intervention that leverages mHealth to help older adults achieve more minutes of MVPA independently. This pilot study was a 12-week randomized controlled trial to investigate the feasibility of providing just-in-time (JIT) feedback about PA intensity during free-living exercise sessions to help older adults meet current PA recommendations (150 minutes per week of MVPA). METHODS: Participants were eligible if they were cognitively healthy English speakers aged between 65 and 80 years without major cardiovascular, neurologic, or mental health conditions; could ambulate independently; and undergo magnetic resonance imaging. Enrollment occurred from October 2017 to March 2020. Participants randomized to the PA condition received an individualized exercise prescription and an mHealth device that provided heart rate-based JIT feedback on PA intensity, allowing them to adjust their behavior in real time to maintain MVPA during exercise sessions. Participants assigned to the healthy aging education condition received a reading prescription consisting of healthy aging topics and completed weekly quizzes based on the materials. RESULTS: In total, 44 participants were randomized to the intervention. A follow-up manuscript will describe the results of the intervention as well as discuss screening, recruitment, adverse events, and participants' opinions regarding their participation in the intervention. CONCLUSIONS: The long-term goal of this intervention is to better understand how MVPA affects brain and cognitive health in the real world and extend laboratory findings to everyday life. This pilot randomized controlled trial was conducted to determine the feasibility of using JIT heart rate zone feedback to help older adults independently increase time spent in MVPA while collecting data on the plausible mechanisms of change (frontal and medial temporal cerebral blood flow and cardiorespiratory fitness) that may affect cognition (memory and executive function) to help refine a planned stage 2 behavioral trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT03058146; https://clinicaltrials.gov/ct2/show/NCT03058146. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42980.

Text4Diet: a randomized controlled study using text messaging for weight loss behaviors.

OBJECTIVE: Text-messaging shows promise as a health intervention. This randomized controlled trial evaluated a daily text-messaging weight loss intervention. METHODS: Overweight and obese adults (n=170) in California were randomized to receive daily interactive and personally weight-relevant text-messages or monthly e-newsletters. Participants were measured at baseline, 6 and 12 months. Group differences were assessed in weight loss. Relation of text-messaging adherence to weight loss and change in pedometer steps was examined. RESULTS: There were no group differences in weight loss over 6 (1.53 lb vs 3.72 lb) or 12 months (2.27 lb vs 3.64 lb; control vs intervention). Text-messaging adherence was moderately strong (60-69%). Participants with greater adherence lost more weight at 6 (p=.039) and 12 months (p=.023) than those who were less adherent. Intervention participants' steps increased almost 3000 steps/day over time (p<.05), and higher step counts were associated with greater weight loss (p<.05). Text-messaging satisfaction was moderate to high, and pedometer-related satisfaction was associated with greater weight loss (p<.05). CONCLUSIONS: Although text-messaging had no effect on weight, adherence was associated with improvement in weight-related behaviors and weight outcomes. Text-messages could be a useful adjunct to weight loss treatments.