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Using the Preparation Phase of the Multiphase Optimization Strategy to Develop a Messaging Component for Weight Loss: Formative and Pilot Research.

ABSTRACT: BACKGROUND:Mobile messaging is often used in behavioral weight loss interventions, yet little is known as to the extent to which they contribute to weight loss when part of a multicomponent treatment package. The multiphase optimization strategy (MOST) is a framework that researchers can use to systematically investigate interventions that achieve desirable outcomes given specified constraints. OBJECTIVE:This study describes the use of MOST to develop a messaging intervention as a component to test as part of a weight loss treatment package in a subsequent optimization trial. METHODS:On the basis of our conceptual model, a text message intervention was created to support self-regulation of weight-related behaviors. We tested the messages in the ENLIGHTEN feasibility pilot study. Adults with overweight and obesity were recruited to participate in an 8-week weight loss program. Participants received a commercially available self-monitoring smartphone app, coaching calls, and text messages. The number and frequency of text messages sent were determined by individual preferences, and weight was assessed at 8 weeks. RESULTS:Participants (n=9) in the feasibility pilot study lost 3.2% of their initial body weight over the 8-week intervention and preferred to receive 1.8 texts per day for 4.3 days per week. Researcher burden in manually sending messages was high, and the cost of receiving text messages was a concern. Therefore, a fully automated push notification system was developed to facilitate sending tailored daily messages to participants to support weight loss. CONCLUSIONS:Following the completion of specifying the conceptual model and the feasibility pilot study, the message intervention went through a final iteration. Theory and feasibility pilot study results during the preparation phase informed critical decisions about automation, frequency, triggers, and content before inclusion as a treatment component in a factorial optimization trial. TRIAL REGISTRATION:ClinicalTrials.gov NCT01814072; https://clinicaltrials.gov/ct2/show/NCT01814072.

SUBMITTER: Pfammatter AF

PROVIDER: S-EPMC7254290 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Using the Preparation Phase of the Multiphase Optimization Strategy to Develop a Messaging Component for Weight Loss: Formative and Pilot Research.

Pfammatter Angela Fidler AF Marchese Sara Hoffman SH Pellegrini Christine C Daly Elyse E Davidson Miriam M Spring Bonnie B

JMIR formative research 20200513 5

<h4>Background</h4>Mobile messaging is often used in behavioral weight loss interventions, yet little is known as to the extent to which they contribute to weight loss when part of a multicomponent treatment package. The multiphase optimization strategy (MOST) is a framework that researchers can use to systematically investigate interventions that achieve desirable outcomes given specified constraints.<h4>Objective</h4>This study describes the use of MOST to develop a messaging intervention as a ...[more]

PMID: 32347804

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Project description:BackgroundExtremism continues to raise concerns about conflict and violent attacks that can lead to deaths, injuries, trauma, and stress. Adolescents are especially vulnerable to radicalization by extremists. Given its location in a region that often experiences extremism, Bahrain developed 4 peaceful coexistence lessons and 4 antiextremism lessons to be implemented as part of their Drug Abuse Resistance Education (D.A.R.E.) program.ObjectiveThe aim of this study is to report the results of the preparation phase of the multiphase optimization strategy (MOST) to develop a peaceful coexistence program and an antiextremism program implemented by D.A.R.E. officers in Bahrain.MethodsWe developed conceptual models for the peaceful coexistence and antiextremism programs, indicating which mediators each lesson should target, the proximal outcomes that should be shaped by these mediators, and the distal and ultimate outcomes that the intervention should change. We recruited 20 middle schools to pilot test our research protocol, survey measures, and the existing intervention lessons. A total of 854 seventh and ninth grade students completed a pretest survey, 4 peaceful coexistence intervention lessons, and an immediate posttest survey; and a total of 495 ninth grade students completed the pretest survey, 4 antiextremism lessons, and an immediate posttest survey. A series of 3-level models, nesting students within classrooms within schools, tested mean differences from pretest to posttest.ResultsPilot test results indicated that most measures had adequate reliability and provided promising evidence that the existing lessons could change some of the targeted mediators and proximal outcomes. Specifically, students who completed the peaceful coexistence lessons reported significant changes in 5 targeted mediating variables (eg, injunctive norms about intolerance, P<.001) and 3 proximal outcomes [eg, social skills empathy (P=.008); tolerance beliefs (P=.041)]. Students who completed the antiextremism lessons reported significant changes in 3 targeted mediators [eg, self-efficacy to use resistance skills themselves (P<.001)], and 1 proximal outcome (ie, social skills empathy, P<.001).ConclusionsAn effective antiextremism program has the potential to protect youth from radicalization and increase peaceful coexistence. We used the preparation phase of MOST to (1) develop a conceptual model, (2) identify the 4 lessons in each program as the components we will evaluate in the optimization phase of MOST, (3) pilot test the existing lessons, our newly developed measures, and research protocol, and (4) determine that our optimization objective will be all effective components. We will use these results to revise the existing lessons and conduct optimization trials to evaluate the efficacy of the individual lessons.

Project description:With thousands of mobile health (mHealth) solutions on the market, patients and health care providers struggle to identify which solution to use and prescribe. The lack of evidence-based mHealth solutions may be because of limited research on intervention development and the continued use of traditional research methods for mHealth evaluation. The Multiphase Optimization Strategy (MOST) is a framework that aids in developing interventions that produce the best-expected outcomes (ie, effectiveness), given constraints imposed on affordability, scalability, and efficiency (also known as achieving intervention EASE). The preparation phase of the MOST highlights the importance of formative intervention development-a stage often overlooked and rarely published. The aim of the preparation phase of the MOST is to identify candidate intervention components, create a conceptual model, and define the optimization objective. Although the MOST sets these 3 targets, no guidance is provided on how to conduct quality research within the preparation phase and what specific steps can be taken to identify potential intervention components, develop the conceptual model, and achieve intervention EASE with the implementation context in mind. To advance the applicability of the MOST within the field of implementation science, this study provides an account of the methods used to develop an mHealth intervention using the MOST. Specifically, we provide an example of how to achieve the goals of the preparation phase by outlining the formative development of an mHealth-prompting intervention within a diabetes prevention program. In addition, recommendations are proposed for future researchers to consider when conducting formative research on mHealth interventions with implementation in mind. Given its considerable reach, mHealth has the potential to positively affect public health by decreasing implementation costs and improving accessibility. The MOST is well-suited for the efficient development and optimization of mHealth interventions. By using an implementation-focused lens and outlining the steps in developing an mHealth intervention using the preparation phase of the MOST, this study may guide future intervention developers toward maximizing the impact of mHealth outside academia.

Project description:BackgroundWork-related stress is associated with poor job performance and negative health outcomes. Changing health behaviors through corporate wellness programs can improve physical and mental health and help employees manage stress. This project sought to pilot the potential addition of brief coaching and biofeedback to an 8-week web-based self-help program to improve employee stress using the multiphase optimization strategy.ObjectiveThis study aims to determine which candidate components will be tested in a later optimization phase and at what dose they will be tested, examine the feasibility and acceptability of delivering the different components, investigate whether the outcomes can be feasibly measured, and review evidence to build a conceptual model before the optimization phase.MethodsThe study was positioned within the preparation phase of the multiphase optimization strategy. It is a 2×2×2×2 design with 4 components: 2 types of health coaching and 2 types of biofeedback. All components were tested by turning them on or off. A total of 16 adult office workers (mean age 40, SD 14.3 years; n=15 women) completed an 8-week self-paced web-based stress management and health behavior change program and were randomly assigned to 1 of the 16 conditions, created from a combination of the 4 candidate components. Assessments included web analytics, surveys, and interviews regarding program recommendations, likes, and dislikes.ResultsFindings from the interviews provided suggestions to improve the intervention (eg, separating wellness from stress content) and trial conduct (eg, streamlining the onboarding process). On average, participants logged into the wellness program 83 times (range 36-291), with 75% (12/16) participant retention and 67% (8/12) survey completion. There were no reported problems with coaching or obtaining data from interviews or apps. The interview findings suggested potential mediators to include and assess in a future conceptual model.ConclusionsThe results provided areas to improve the intervention content and trial methods. Instead of progressing to the next scheduled large-scale optimization phase, our plan to iterate through a second preparation phase after making changes to the protocol, apps, and corporate coaching partner.

Project description:Study objectiveTobacco dependence treatment initiated in the hospital emergency department (ED) is effective. However, trials typically use multicomponent interventions, making it difficult to distinguish specific components that are effective. In addition, interactions between components cannot be assessed. The Multiphase Optimization Strategy allows investigators to identify these effects.MethodsWe conducted a full-factorial, 24 or 16-condition optimization trial in a busy hospital ED to examine the performance of 4 tobacco dependence interventions: a brief negotiation interview; 6 weeks of nicotine replacement therapy with the first dose delivered in the ED; active referral to a telephone quitline; and enrollment in SmokefreeTXT, a free short-messaging service program. Study data were analyzed with a novel mixed methods approach to assess clinical efficacy, cost-effectiveness, and qualitative participant feedback. The primary endpoint was tobacco abstinence at 3 months, verified by exhaled carbon monoxide using a Bedfont Micro+ Smokerlyzer.ResultsBetween February 2017 and May 2019, we enrolled 1,056 adult smokers visiting the ED. Odd ratios (95% confidence intervals) from the primary analysis of biochemically confirmed abstinence rates at 3 months for each intervention, versus control, were: brief negotiation interview, 1.8 (1.1, 2.8); nicotine replacement therapy, 2.1 (1.3, 3.2); quitline, 1.4 (0.9, 2.2); SmokefreeTXT, 1.1 (0.7, 1.7). There were no statistically significant interactions among components. Economic and qualitative analyses are in progress.ConclusionThe brief negotiation interview and nicotine replacement therapy were efficacious. This study is the first to identify components of ED-initiated tobacco dependence treatment that are individually effective. Future work will address the scalability of the brief negotiation interview and nicotine replacement therapy by offering provider-delivered brief negotiation interviews and nicotine replacement therapy prescriptions.

Project description:BackgroundPoor diabetes self-management in emerging adulthood (age 18-25 years) is associated with poorer diabetes health and diabetes complications. Emerging adults' focus on individuation and independence underlies their poor diabetes outcomes, offering a lever for behavior change. Self-determination theory (SDT) suggests that interventions leveraging emerging adults' innate developmental need for autonomy may offer a route to improving diabetes outcomes by increasing feelings of responsibility for and control over diabetes self-management activities.ObjectiveThis research project will use the multiphase optimization strategy to test the efficacy of three autonomy-supportive intervention components to elicit a clinically significant improvement in metabolic control, assessed by a 0.5% improvement in hemoglobin A1c (HbA1c), among older adolescents and emerging adults (16-25 years) with poorly controlled type 1 diabetes (T1D; HbA1c≥9.0%).MethodsA question prompt list (QPL) is a tool to empower patients to assume a more active role during medical visits by asking questions and stating concerns. The motivation enhancement system (MES) is a brief counseling intervention that uses motivational interviewing communication strategies to build intrinsic motivation and self-efficacy for self-management. Text message reminders to complete diabetes care tasks may increase self-efficacy for diabetes self-management. After refining these intervention components for emerging adults, we will conduct a component selection experiment using an eight-arm full factorial design: 2 (QPL yes or no)×2 (MES yes or no)×2 (Text yes or no). Participants will complete 3 study visits: baseline, treatment end at 2 months, and a follow-up at 6 months. The primary outcome is metabolic control, which will be measured via HbA1c. Secondary outcomes include diabetes management and diabetes clinic attendance. SDT constructs of intrinsic motivation, self-efficacy, and the quality of the patient-provider relationship (ie, relatedness) are hypothesized mediators. Depression symptoms and emerging adults' gender are hypothesized moderators. We will use the mixed-effects linear model for the analysis of variance of a factorial design to analyze continuous longitudinal experimental data; the generalized linear model will be used with categorical outcomes (eg, treatment attendance). The experiment was powered to detect the main effects of the intervention on the primary outcome.ResultsA total of 20 participants have enrolled and completed a qualitative interview after reviewing one or more intervention components. Analysis of interview data are underway, with a report of these results anticipated in the fall of 2020. The clinical trial will be launched in the fall 2020, with participants enrolled through May 2023 and data collection continuing through November 2023.ConclusionsAt the end of this experiment, we will have empirical evidence to support a large-scale, multisite effectiveness trial of an intervention package that has been optimized for older adolescents and emerging adults with poorly controlled T1D.Trial registrationClinicalTrials.gov NCT04066959; https://clinicaltrials.gov/ct2/show/NCT04066959.International registered report identifier (irrid)DERR1-10.2196/20191.

Project description:Background/aimsPreventing 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.MethodsA 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.ResultsFour 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.ConclusionThis 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.

Dataset Information

Using the Preparation Phase of the Multiphase Optimization Strategy to Develop a Messaging Component for Weight Loss: Formative and Pilot Research.

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Using the Preparation Phase of the Multiphase Optimization Strategy to Develop a Messaging Component for Weight Loss: Formative and Pilot Research.

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