Evaluating strategies to recruit health researchers to participate in online survey research.

BACKGROUND: Engaging researchers as research subjects is key to informing the development of effective and relevant research practices. It is important to understand how best to engage researchers as research subjects. METHODS: A 24 factorial experiment, as part of a Multiphase Optimization Strategy, was performed to evaluate effects of four recruitment strategy components on participant opening of an emailed survey link and survey completion. Participants were members of three US-based national health research consortia. A stratified simple random sample was used to assign potential survey participants to one of 16 recruitment scenarios. Recruitment strategy components were intended to address both intrinsic and extrinsic sources of motivation, including: $50 gift, $1,000 raffle, altruistic messaging, and egoistic messaging. Multivariable generalized linear regression analyses adjusting for consortium estimated component effects on outcomes. Potential interactions among components were tested. Results are reported as adjusted odds ratios (aOR) with 95% confidence intervals (95% CI). RESULTS: Surveys were collected from June to December 2023. A total of 418 participants were included from the consortia, with final analytical sample of 400 eligible participants. Out of the final sample, 82% (341) opened the survey link and 35% (147) completed the survey. Altruistic messaging increased the odds of opening the survey (aOR 2.02, 95% CI: 1.35-2.69, p = 0.033), while egoistic messaging significantly reduced the odds of opening the survey (aOR 0.56, 95%CI 0.38-0.75, p = 0.08). The receipt of egoistic messaging increased the odds of completing the survey once opened (aOR 1.81, 95%CI: 1.39-2.23, p < 0.05). There was a significant negative interaction effect between the altruistic appeal and egoistic messaging strategies for survey completion outcome. Monetary incentives did not a have a significant impact on survey completion. CONCLUSION: Intrinsic motivation is likely to be a greater driver of health researcher participation in survey research than extrinsic motivation. Altruistic and egoistic messaging may differentially impact initial interest and survey completion and when combined may lead to improved rates of recruitment, but not survey completion. Further research is needed to determine how to best optimize message content and whether the effects observed are modified by survey burden.

Empirical Development of a Behavioral Intervention for African American/Black and Latino Persons with Unsuppressed HIV Viral Load Levels: An Application of the Multiphase Optimization Strategy (MOST) Using Cost-Effectiveness as an Optimization Objective.

We used results from an optimization randomized controlled trial which tested five behavioral intervention components to support HIV antiretroviral adherence/HIV viral suppression, grounded in the multiphase optimization strategy and using a fractional factorial design to identify intervention components with cost-effectiveness sufficiently favorable for scalability. Results were incorporated into a validated HIV computer simulation to simulate longer-term effects of combinations of components on health and costs. We simulated the 32 corresponding long-term trajectories for viral load suppression, health related quality of life (HRQoL), and costs. The components were designed to be culturally and structurally salient. They were: motivational interviewing counseling sessions (MI), pre-adherence skill building (SB), peer mentorship (PM), focused support groups (SG), and patient navigation (short version [NS], long version [NL]. All participants also received health education on HIV treatment. We examined four scenarios: one-time intervention with and without discounting and continuous interventions with and without discounting. In all four scenarios, interventions that comprise or include SB and NL (and including health education) were cost effective (< $100,000/quality-adjusted life year). Further, with consideration of HRQoL impact, maximal intervention became cost-effective enough to be scalable. Thus, a fractional factorial experiment coupled with cost-effectiveness analysis is a promising approach to optimize multi-component interventions for scalability. The present study can guide service planning efforts for HIV care settings and health departments.

Intervention Optimization: A Paradigm Shift and Its Potential Implications for Clinical Psychology.

To build a coherent knowledge base about what psychological intervention strategies work, develop interventions that have positive societal impact, and maintain and increase this impact over time, it is necessary to replace the classical treatment package research paradigm. The multiphase optimization strategy (MOST) is an alternative paradigm that integrates ideas from behavioral science, engineering, implementation science, economics, and decision science. MOST enables optimization of interventions to strategically balance effectiveness, affordability, scalability, and efficiency. In this review we provide an overview of MOST, discuss several experimental designs that can be used in intervention optimization, consider how the investigator can use experimental results to select components for inclusion in the optimized intervention, discuss the application of MOST in implementation science, and list future issues in this rapidly evolving field. We highlight the feasibility of adopting this new research paradigm as well as its potential to hasten the progress of psychological intervention science.

The physical activity in cancer survivors (PACES) trial: a factorial randomized trial to optimize intervention for breast cancer survivors.

Multiple intervention strategies have been found effective for increasing physical activity among breast cancer survivors, yet most breast cancer survivors fail to meet physical activity recommendations. Optimization of interventions can facilitate real word implementation to ensure effective and efficient intervention delivery. Using a full-factorial design based on the Multiphase Optimization Strategy, 337 breast cancer survivors were randomized to receive a combination of four intervention components: (1) supervised exercise sessions, (2) facility membership, (3) Active Living Every Day (ALED), and (4) Fitbit. Moderate-to vigorous (MVPA) and light-intensity physical activity (LPA) were measured at baseline, 3 months, and 6 months with a hip-worn Actigraph GT3X+. Normal linear mixed models with separate intercepts for each subject were fit in the SAS 9.4 Mixed procedure. Participants who received supervised exercise sessions engaged in more MVPA, 153.58 min/week vs. 133.0 min/week (F = 3.97, p = 0.048) and LPA, 170.26 min/day versus 160.98 light PA minutes/day (F = 4.67, p = 0.032), compared to participants who did not receive supervised exercise. The effects of the three other intervention components on MVPA were not significant; however, those that received ALED engaged in less LPA (F = 6.6, p = 0.011). Supervised exercise sessions resulted in significant increases in MVPA and LPA in a sample of breast cancer survivors. Of note, these sessions were provided only during the first 6 weeks of the intervention and effects remained significant at 6 months. Results of this trial could inform future implementation efforts to ensure effective and efficient delivery of physical activity programs for breast cancer survivors.

Optimizing smartphone psychotherapy for depressive symptoms in patients with cancer: Multiphase optimization strategy using a decentralized multicenter randomized clinical trial (J-SUPPORT 2001 Study).

AIM: Patients with cancer experience various forms of psychological distress, including depressive symptoms, which can impact quality of life, elevate morbidity risk, and increase medical costs. Psychotherapy and pharmacotherapy are effective for reducing depressive symptoms among patients with cancer, but most patients prefer psychotherapy. This study aimed to develop an efficient and effective smartphone psychotherapy component to address depressive symptom. METHODS: This was a decentralized, parallel-group, multicenter, open, individually randomized, fully factorial trial. Patients aged ≥20 years with cancer were randomized by the presence/absence of three cognitive-behavioral therapy (CBT) skills (behavioral activation [BA], assertiveness training [AT], and problem-solving [PS]) on a smartphone app. All participants received psychoeducation (PE). The primary outcome was change in the patient health questionnaire-9 (PHQ-9) total score between baseline and week 8. Secondary outcomes included anxiety. RESULTS: In total, 359 participants were randomized. Primary outcome data at week 8 were obtained for 355 participants (99%). The week 8 PHQ-9 total score was significantly reduced from baseline for all participants by -1.41 points (95% confidence interval [CI] -1.89, -0.92), but between-group differences in change scores were not significant (BA: -0.04, 95% CI -0.75, 0.67; AT: -0.16, 95% CI -0.87, 0.55; PS: -0.19, 95% CI -0.90, 0.52). CONCLUSION: As the presence of any of the three intervention components did not contribute to a significant additive reduction of depressive symptoms, we cannot make evidence-based recommendations regarding the use of specific smartphone psychotherapy.

Optimizing Interventions for Equitability: Some Initial Ideas.

Interventions (including behavioral, biobehavioral, biomedical, and social-structural interventions) hold tremendous potential not only to improve public health overall but also to reduce health disparities and promote health equity. In this study, we introduce one way in which interventions can be optimized for health equity in a principled fashion using the multiphase optimization strategy (MOST). Specifically, we define intervention equitability as the extent to which the health benefits provided by an intervention are distributed evenly versus concentrated among those who are already advantaged, and we suggest that, if intervention equitability is acknowledged to be a priority, then equitability should be a key criterion that is balanced with other criteria (effectiveness overall, as well as affordability, scalability, and/or efficiency) in intervention optimization. Using a hypothetical case study and simulated data, we show how MOST can be applied to achieve a strategic balance that incorporates equitability. We also show how the composition of an optimized intervention can differ when equitability is considered versus when it is not. We conclude with a vision for next steps to build on this initial foray into optimizing interventions for equitability.

Critical Dialogue and Capacity-Building Projects Reduced Alcohol and Substance Use in a Randomized Clinical Trial Among Formerly Incarcerated Men.

Background: Rates of alcohol and/or substance use (ASU) among residents of predominantly Black and marginalized communities are similar to ASU rates in White communities. Yet ASU has worse consequences in predominantly Black and marginalized communities (e.g., higher incarceration). Objective: We randomized participants to one of 16 intervention conditions using a 24 full factorial design to optimize a multilevel intervention reducing ASU among 602 formerly incarcerated men with substance-use-disorders (SUD). Candidate intervention components included (1) critical dialogue (CD; six weekly 2-hour-long group sessions vs. no CD sessions), (2) Quality of Life Wheel (QLW; six weekly 1-hour-long group sessions vs. no QLW sessions), (3) capacity building projects (CBP; six weekly 1-hour-long group sessions vs. no CBP sessions), and (4) delivery by a trained peer versus licensed facilitators. Outcome was percentage of days in which participants used alcohol, cocaine, opioid, and/or cannabis in previous 30 days. Results: Intent-to-treat analysis did not meet a priori component selection criteria due to low intervention attendance. After controlling for intervention group attendance (percentage of sessions attended), peer-delivered CD and CBP produced statistically and clinically significant main and interaction effects in ASU over 5 months. Per the multiphase optimization strategy framework, we selected peer-delivered CD and CBP for inclusion as the optimized version of the intervention with a cost of US$1,380 per 10 individuals. No adverse intervention effects occurred. Conclusion: CD and CBP were identified as the only potentially effective intervention components. Future research will examine strategies to improve attendance and test the optimized intervention against standard of care in a randomized-controlled-trial.

Effects of Behavioral Intervention Components for African American/Black and Latino Persons Living with HIV with Non-suppressed Viral Load Levels: Results of an Optimization Trial.

There is an urgent need for efficient behavioral interventions to increase rates of HIV viral suppression for populations with serious barriers to engagement along the HIV care continuum. We carried out an optimization trial to test the effects of five behavioral intervention components designed to address barriers to HIV care continuum engagement for African American/Black and Latino persons living with HIV (PLWH) with non-suppressed HIV viral load levels: motivational interviewing sessions (MI), focused support groups (SG), peer mentorship (PM), pre-adherence skill building (SB), and navigation with two levels, short (NS) and long (NL). The primary outcome was HIV viral suppression (VS) and absolute viral load (VL) and health-related quality of life were secondary outcomes. Participants were 512 African American/Black and Latino PLWH poorly engaged in HIV care and with detectable HIV viral load levels in New York City, recruited mainly through peer referral. Overall, VS increased to 37%, or 45% in a sensitivity analysis. MI and SG seemed to have antagonistic effects on VS (z = - 1.90; p = 0.057); the probability of VS was highest when either MI or SG was assigned, but not both. MI (Mean Difference = 0.030; 95% CI 0.007-0.053; t(440) = 2.60; p = 0.010) and SB (Mean Difference = 0.030; 95% CI 0.007-0.053; t(439) = 2.54; p = 0.012) improved health-related quality of life. This is the first optimization trial in the field of HIV treatment. The study yields a number of insights into approaches to improve HIV viral suppression in PLWH with serious barriers to engagement along the HIV care continuum, including chronic poverty, and underscores challenges inherent in doing so.

Exploring behavioral intervention components for African American/Black and Latino persons living with HIV with non-suppressed HIV viral load in the United States: a qualitative study.

BACKGROUND: The persistence of racial/ethnic inequities in rates of engagement along the HIV care continuum signals the need for novel approaches. We developed six behavioral intervention components for use in an optimization trial, grounded in a model that integrates critical race theory, harm reduction, and self-determination theory, designed to address various barriers that African American/Black and Latino persons living with HIV (PLWH) experience to the HIV care continuum. The components were: health education, motivational interviewing sessions, pre-adherence skill building, peer mentorship, focused support groups, and navigation. The present qualitative exploratory study describes participants' perspectives on the components' acceptability, feasibility, and impact. METHODS: Participants were African American/Black and Latino PLWH poorly engaged in HIV care and with non-suppressed HIV viral load in New York City. From a larger trial, we randomly selected 46 participants for in-depth semi-structured interviews. Interviews were audio-recorded and transcribed verbatim, and data were analyzed using directed content analysis. Quantitative data on sociodemographic and background characteristics and components' acceptability and feasibility were also collected. RESULTS: On average, participants were 49 years old and had lived with HIV for 19 years. Most were cisgender-male and African American/Black. Participants reported a constellation of serious social and structural challenges to HIV management including chronic poverty, unstable housing, and stigma. Across components, a non-judgmental and pressure-free approach and attention to structural and cultural factors were seen as vital to high levels of engagement, but lacking in most medical/social service settings. Prominent aspects of individual components included establishing trust (health education); developing intrinsic motivation, goals, and self-reflection (motivational interviewing sessions); learning/practicing adherence strategies and habits (pre-adherence skill building); reducing social isolation via peer role models (peer mentorship); reflecting on salient goals and common challenges with peers without stigma (focused support groups); and circumventing structural barriers to HIV management with support (navigation). Components were found acceptable and feasible. Findings suggested ways components could be improved. CONCLUSIONS: The present study advances research on interventions for African American/Black and Latino PLWH, who experience complex barriers to engagement along the HIV care continuum. Future study of the components is warranted to address racial/ethnic health inequities in HIV.

Designing a childhood obesity preventive intervention using the multiphase optimization strategy: The Healthy Bodies Project.

BACKGROUND/AIMS: Preventing the development of childhood obesity requires multilevel, multicomponent, comprehensive approaches. Study designs often do not allow for systematic evaluation of the efficacy of individual intervention components before the intervention is fully tested. As such, childhood obesity prevention programs may contain a mix of effective and ineffective components. This article describes the design and rationale of a childhood obesity preventive intervention developed using the multiphase optimization strategy, an engineering-inspired framework for optimizing behavioral interventions. Using a series of randomized experiments, the objective of the study was to systematically test, select, and refine candidate components to build an optimized childhood obesity preventive intervention to be evaluated in a subsequent randomized controlled trial. METHODS: A 24 full factorial design was used to test the individual and combined effects of four candidate intervention components intended to reduce the risk for childhood obesity. These components were designed with a focus on (a) improving children's healthy eating behaviors and nutrition knowledge, (b) increasing physical activity and reducing sedentary activity in the childcare setting, (c) improving children's behavioral self-regulation, and (d) providing parental web-based education to address child target outcomes. The components were tested with approximately 1400 preschool children, ages 3-5 years in center-based childcare programs in Pennsylvania, the majority of which served predominantly Head-Start eligible households. Primary child outcomes included healthy eating knowledge, physical and sedentary activity, and behavioral self-regulation. Secondary outcomes included children's body mass index and appetitive traits related to appetite regulation. RESULTS: Four intervention components were developed, including three classroom curricula designed to increase preschool children's nutrition knowledge, physical activity, and behavioral, emotional, and eating regulation. A web-based parent education component included 18 lessons designed to improve parenting practices and home environments that would bolster the effects of the classroom curricula. A plan for analyzing the specific contribution of each component to a larger intervention was developed and is described. The efficacy of the four components can be evaluated to determine the extent to which they, individually and in combination, produce detectable changes in childhood obesity risk factors. The resulting optimized intervention should later be evaluated in a randomized controlled trial, which may provide new information on promising targets for obesity prevention in young children. CONCLUSION: This research project highlights the ways in which an innovative approach to the design and initial evaluation of preventive interventions may increase the likelihood of long-term success. The lessons from this research project have implications for childhood obesity research as well as other preventive interventions that include multiple components, each targeting unique contributors to a multifaceted problem.

CATCH-UP vaccines: protocol for a randomized controlled trial using the multiphase optimization strategy (MOST) framework to evaluate education interventions to increase COVID-19 vaccine uptake in Oklahoma.

BACKGROUND: Oklahoma's cumulative COVID-19 incidence is higher in rural than urban counties and higher than the overall US incidence. Furthermore, fewer Oklahomans have received at least one COVID-19 vaccine compared to the US average. Our goal is to conduct a randomized controlled trial using the multiphase optimization strategy (MOST) to test multiple educational interventions to improve uptake of COVID-19 vaccination among underserved populations in Oklahoma. METHODS: Our study uses the preparation and optimization phases of the MOST framework. We conduct focus groups among community partners and community members previously involved in hosting COVID-19 testing events to inform intervention design (preparation). In a randomized clinical trial, we test three interventions to improve vaccination uptake: (1) process improvement (text messages); (2) barrier elicitation and reduction (electronic survey with tailored questions/prompts); and (2) teachable moment messaging (motivational interviewing) in a three-factor fully crossed factorial design (optimization). DISCUSSION: Because of Oklahoma's higher COVID-19 impact and lower vaccine uptake, identifying community-driven interventions is critical to address vaccine hesitancy. The MOST framework provides an innovative and timely opportunity to efficiently evaluate multiple educational interventions in a single study. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05236270, First Posted: February 11, 2022, Last Update Posted: August 31, 2022.

Suubi + Adherence4Youth: a study protocol to optimize the Suubi Intervention for Adherence to HIV treatment for youth living with HIV in Uganda.

BACKGROUND: Suubi is an evidenced based multi-component intervention that targets psychosocial and economic hardships to improve ART adherence, viral suppression, mental health, family financial stability, and family cohesion for adolescents living with HIV (ALHIV) in Uganda. Suubi was originally tested as a combined package of four components: 1) Financial Literacy Training; 2) incentivized matched Youth Savings Accounts with income-generating activities; 3) a manualized and visual-based intervention for ART adherence and stigma reduction; and 4) engagement with HIV treatment-experienced role models. However, it is unknown if each component in Suubi had a positive effect, how the components interacted, or if fewer components could have produced equivalent effects. Hence, the overall goal of this new study is to identify the most impactful and sustainable economic and psychosocial components across 48 health clinics in Uganda. METHODS: A total of 576 ALHIV (aged 11-17 years at enrollment) will be recruited from 48 clinics and each clinic will be randomized to one of 16 study conditions. Each condition represents every possible combination of the 4 components noted above. Assessments will be conducted at baseline, 12, 24, 36 and 48- months post-intervention initiation. Using the multi-phase optimization strategy (MOST), we will identify the optimal combination of components and associated costs for viral suppression, as well as test key mediators and moderators of the component-viral suppression relationship. DISCUSSION: The study is a shift in the paradigm of research to use new thinking to build/un-pack highly efficacious interventions that lead to new scientific knowledge in terms of understanding what drives an intervention's success and how to iterate on them in ways that are more efficient, affordable and scalable. The study advances intervention science for HIV care outcomes globally. TRIAL REGISTRATION: This project was registered at clinicaltrials.gov (NCT05600621) on October, 31, 2022. https://clinicaltrials.gov/ct2/show/NCT05600621.

A factorial experiment grounded in the multiphase optimization strategy to promote viral suppression among people who inject drugs on the Texas-Mexico border: a study protocol.

BACKGROUND: People who inject drugs living with HIV (PWIDLH) suffer the lowest rates of HIV viral suppression due to episodic injection drug use and poor mental health coupled with poor retention in HIV care. Approximately 44% of PWIDLH along the US-Mexico border are retained in care and only 24% are virally suppressed. This underserved region faces a potential explosion of transmission of HIV due to highly prevalent injection drug use. This protocol describes an optimization trial to promote sustained viral suppression among Spanish-speaking Latinx PWIDLH. METHODS: The multiphase optimization strategy (MOST) is an engineering-inspired framework for designing and building optimized interventions and guides this intervention. The primary aim is to conduct a 24 factorial experiment in which participants are randomized to one of 16 intervention conditions, with each condition comprising a different combination of four behavioral intervention components. The components are peer support for methadone uptake and persistence; behavioral activation therapy for depression; Life-Steps medication adherence counseling; and patient navigation for HIV care. Participants will complete a baseline survey, undergo intervention, and then return for 3-,6-,9-, and 12-month follow-up assessments. The primary outcome is sustained viral suppression, defined as viral loads of < 40 copies per mL at 6-,9-, and 12-month follow-up assessments. Results will yield effect sizes for each component and each additive and interactive combination of components. The research team and partners will make decisions about what constitutes the optimized multi-component intervention by judging the observed effect sizes, interactions, and statistical significance against real-world implementation constraints. The secondary aims are to test mediators and moderators of the component-to-outcome relationship at the 6-month follow-up assessment. DISCUSSION: We are testing well-studied and available intervention components to support PWIDLH to reduce drug use and improve their mental health and engagement in HIV care. The intervention design will allow for a better understanding of how these components work in combination and can be optimized for the setting. TRIAL REGISTRATION: This project was registered at clinicaltrials.gov (NCT05377463) on May 17th, 2022.

Evaluation of Combinations of Nudging, Pricing, and Labeling Strategies to Improve Diet Quality: A Virtual Grocery Store Experiment Employing a Multiphase Optimization Strategy.

BACKGROUND: Several intervention strategies have been shown to improve diet quality. However, there is limited evidence on the increase in effectiveness that may be achieved through select combinations of these strategies. PURPOSE: This study aimed to identify an effective multicomponent intervention to improve diet quality of a grocery basket by applying a Multiphase Optimization Strategy framework and testing various combinations of four promising strategies using a fully functional web-based grocery store: (i) front-of-pack food labels and real-time feedback of the healthiness of the shoppers' grocery basket, (ii) a tax, (iii) ordering products by a nutritional quality score, and (iv) healthier substitute offers. METHODS: We conducted a hypothetical shopping study (N = 756) with a randomized full factorial design (16 conditions) to estimate main and interaction effects of the four interventions. RESULTS: The "food labels & real-time feedback" and "ordering" strategies had significantly positive main effects on overall diet quality of the shopping basket (both at p < .001). We found no effects on diet quality for the "tax" and "healthier substitute offers." None of the two-way interaction effects for different strategies on overall diet quality and nutrients were significant. CONCLUSIONS: Having "food labels & real-time feedback" and "ordering" simultaneously seemed to be more effective at improving diet quality, compared to having only one of these interventions. These results suggest that a combination of food labels with real-time feedback and ordering interventions can be part of a promising multicomponent strategy to improve diet quality in online shopping platforms. TRIAL REGISTRATION: ClinicalTrials.gov NCT04632212.

Using the multiphase optimization strategy (MOST) framework to optimize an intervention to increase COVID-19 testing for Black and Latino/Hispanic frontline essential workers: A study protocol.

BACKGROUND: Among those at highest risk for COVID-19 exposure is the large population of frontline essential workers in occupations such food service, retail, personal care, and in-home health services, among whom Black and Latino/Hispanic persons are over-represented. For those not vaccinated and at risk for exposure to COVID-19, including frontline essential workers, regular (approximately weekly) COVID-19 testing is recommended. However, Black and Latino/Hispanic frontline essential workers in these occupations experience serious impediments to COVID-19 testing at individual/attitudinal- (e.g., lack of knowledge of guidelines), social- (e.g., social norms), and structural-levels of influence (e.g., poor access), and rates of testing for COVID-19 are insufficient. METHODS/DESIGN: The proposed community-engaged study uses the multiphase optimization strategy (MOST) framework and an efficient factorial design to test four candidate behavioral intervention components informed by an integrated conceptual model that combines critical race theory, harm reduction, and self-determination theory. They are A) motivational interview counseling, B) text messaging grounded in behavioral economics, C) peer education, and D) access to testing (via navigation to an appointment vs. a self-test kit). All participants receive health education on COVID-19. The specific aims are to: identify which components contribute meaningfully to improvement in the primary outcome, COVID-19 testing confirmed with documentary evidence, with the most effective combination of components comprising an "optimized" intervention that strategically balances effectiveness against affordability, scalability, and efficiency (Aim 1); identify mediators and moderators of the effects of components (Aim 2); and use a mixed-methods approach to explore relationships among COVID-19 testing and vaccination (Aim 3). Participants will be N = 448 Black and Latino/Hispanic frontline essential workers not tested for COVID-19 in the past six months and not fully vaccinated for COVID-19, randomly assigned to one of 16 intervention conditions, and assessed at 6- and 12-weeks post-baseline. Last, N = 50 participants will engage in qualitative in-depth interviews. DISCUSSION: This optimization trial is designed to yield an effective, affordable, and efficient behavioral intervention that can be rapidly scaled in community settings. Further, it will advance the literature on intervention approaches for social inequities such as those evident in the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05139927 ; Registered on 11/29/2021. Protocol version 1.0. May 2, 2022, Version 1.0.

Supporting family meal frequency: Screening Phase results from the Simply Dinner Study.

We aimed to test main, additive, interactive effects, and feasibility of all possible combinations of six intervention components implemented for 8 weeks (Cooking/Serving Resources; Meal Delivery; Ingredient Delivery; Community Kitchen; Nutrition Education; Cooking Demonstrations). Primary outcomes were family meal frequency and preschoolers' dietary quality; secondary outcomes included family meal preparation type, meal preparation barriers, family functioning, and kitchen inventory adequacy. All possible intervention combinations were tested using a randomized factorial trial design in the first phase of a Multiphase Optimization Strategy (MOST). Feasibility was assessed via attendance, delivery logs, and satisfaction. Parent-reported data collection included: socio-demographics, frequency and type of family meals; preschooler dietary intake; perceived barriers to meal planning and preparation; assessment of family functioning; and a kitchen inventory of materials generally needed for meal preparation. Participants (n = 499) were recruited at two Head Start agencies in mid-Michigan with data collection and delivery of some intervention components in participants' homes. Promising intervention bundles were identified by evaluating pre-to post-intervention effect sizes. The combination of Cooking/Serving Resources and Meal Delivery increased family meal frequency (Cohen's d = 0.17), cooking dinner from scratch (d = 0.21), prioritization of family meals (d = 0.23), and kitchen inventory (d = 0.46) and decreased use/consumption of ready-made (d = -0.18) and fast foods (d = -0.23). Effects on diet quality were in the expected direction but effect sizes were negligible. Community Kitchen, Nutrition Education, and Cooking Demonstration showed poor feasibility due to low attendance while Ingredient Delivery was infeasible due to staffing challenges related to its labor intensity. Additionally, although not one of our pre-specified outcomes, Cooking/Serving Resources (RR = 0.74) and Meal Delivery (RR = 0.73) each decreased food insecurity. Cooking/Serving Resources combined with Meal Delivery showed promise as a strategy for increasing family meal frequency.

A Hybrid Evaluation-Optimization Trial to Evaluate an Intervention Targeting the Intersection of Alcohol and Sex in College Students and Simultaneously Test an Additional Component Aimed at Preventing Sexual Violence.

BACKGROUND: Using the multiphase optimization strategy (MOST), we previously developed and optimized an online behavioral intervention, itMatters, aimed at reducing the risk of sexually transmitted infections (STI) among first-year college students by targeting the intersection of alcohol use and sexual behaviors. PURPOSE: We had two goals: (a) to evaluate the optimized itMatters intervention and (b) to determine whether the candidate sexual violence prevention (SVP) component (included at the request of participating universities) had a detectable effect and therefore should be added to create a new version of itMatters. We also describe the hybrid evaluation-optimization trial we conducted to accomplish these two goals in a single experiment. METHODS: First year college students (N = 3,098) at four universities in the USA were individually randomized in a hybrid evaluation-optimization 2 × 2 factorial trial. Data were analyzed using regression models, with pre-test outcome variables included as covariates in the models. Analyses were conducted separately with (a) immediate post-test scores and (b) 60-day follow-up scores as outcome variables. RESULTS: Experimental results indicated a significant effect of itMatters on targeted proximal outcomes (norms) and on one distal behavioral outcome (binge drinking). There were no significant effects on other behavioral outcomes, including the intersection of alcohol and sexual behaviors. In addition, there were mixed results (positive short-term effect; no effect at 60-day follow-up) of the SVP component on targeted proximal outcomes (students' self-efficacy to reduce/prevent sexual violence and perceived effectiveness of protective behavioral strategies). CONCLUSIONS: The hybrid evaluation-optimization trial enabled us to evaluate the individual and combined effectiveness of the optimized itMatters intervention and the SVP component in a single experiment, conserving resources and providing greatly improved efficiency. TRIAL REGISTRATION: NCT04095065.

The project COMPASS protocol: Optimizing mindfulness and acceptance-based behavioral treatment for binge-eating spectrum disorders.

Outcomes from cognitive behavioral therapy for binge-eating spectrum disorders are suboptimal, possibly due in part to deficits in self-regulation (i.e., the ability to control behavior in pursuit of long-term goals despite internal challenges). Mindfulness and acceptance-based treatments (MABTs) integrate behavioral treatment with psychological strategies designed to enhance self-regulation, yet little is known about how and for whom they are effective. The present study will utilize the multiphase optimization strategy to identify which of four MABT components (mindful awareness, distress tolerance, emotion modulation, values-based decision making) to include in a fully powered clinical trial. Participants (n = 256) will be randomized to 16 sessions in one of 16 conditions, each a different combination of MABT components being included or excluded from a base behavioral treatment. Our primary aim is to evaluate each component's independent efficacy on disordered eating symptoms. Our secondary aims are to confirm each component's target engagement (i.e., whether each component improves the targeted variable and outcomes), and test that each component's efficacy is moderated by baseline weaknesses in the same component (e.g., that participants with poor distress tolerance at baseline benefit most from the distress tolerance component). Our exploratory aim is to quantify the component interaction effects.

Developing a Psychological-Behavioral Intervention in Cardiac Patients Using the Multiphase Optimization Strategy: Lessons Learned From the Field.

BACKGROUND: The Multiphase Optimization Strategy (MOST) is an approach to systematically and efficiently developing a behavioral intervention using a sequence of experiments to prepare and optimize the intervention. PURPOSE: Using a 6 year MOST-based behavioral intervention development project as an example, we outline the results-and resulting decision-making process-related to experiments at each step to display the practical challenges present at each stage. METHODS: To develop a positive psychology (PP) based intervention to promote physical activity after an acute coronary syndrome (N = 255 across four phases), we utilized qualitative, proof-of-concept, factorial design, and randomized pilot experiments, with iterative modification of intervention content and delivery. RESULTS: Through this multiphase approach, we ultimately developed a 12 week, phone-delivered, combined PP-motivational interviewing intervention to promote physical activity. Across stages, we learned several important lessons: (a) participant and interventionist feedback is important, even in later optimization stages; (b) a thoughtful and systematic approach using all information sources is required when conflicting results in experiments make next steps unclear; and (3) new approaches in the field over a multiyear project should be integrated into the development process. CONCLUSIONS: A MOST-based behavioral intervention development program can be efficient and effective in developing optimized new interventions, and it may require complex and nuanced decision-making at each phase.

Tutorial for Using Control Systems Engineering to Optimize Adaptive Mobile Health Interventions.

BACKGROUND: Adaptive behavioral interventions are individualized interventions that vary support based on a person's evolving needs. Digital technologies enable these adaptive interventions to function at scale. Adaptive interventions show great promise for producing better results compared with static interventions related to health outcomes. Our central thesis is that adaptive interventions are more likely to succeed at helping individuals meet and maintain behavioral targets if its elements can be iteratively improved via data-driven testing (ie, optimization). Control systems engineering is a discipline focused on decision making in systems that change over time and has a wealth of methods that could be useful for optimizing adaptive interventions. OBJECTIVE: The purpose of this paper was to provide an introductory tutorial on when and what to do when using control systems engineering for designing and optimizing adaptive mobile health (mHealth) behavioral interventions. OVERVIEW: We start with a review of the need for optimization, building on the multiphase optimization strategy (MOST). We then provide an overview of control systems engineering, followed by attributes of problems that are well matched to control engineering. Key steps in the development and optimization of an adaptive intervention from a control engineering perspective are then summarized, with a focus on why, what, and when to do subtasks in each step. IMPLICATIONS: Control engineering offers exciting opportunities for optimizing individualization and adaptation elements of adaptive interventions. Arguably, the time is now for control systems engineers and behavioral and health scientists to partner to advance interventions that can be individualized, adaptive, and scalable. This tutorial should aid in creating the bridge between these communities.