Optimization of remotely delivered intensive lifestyle treatment for obesity using the Multiphase Optimization Strategy: Opt-IN study protocol.
Ontology highlight
ABSTRACT:
SUBMITTER: Pellegrini CA
PROVIDER: S-EPMC4104542 | biostudies-other | 2014 Jul
REPOSITORIES: biostudies-other
Similar Datasets
Project description:BackgroundEffective weight loss interventions exist, yet few can be scaled up for wide dissemination. Further, none has been fully delivered via text message. We used the multiphase optimization strategy (MOST) to develop multicomponent interventions that consist only of active components, those that have been experimentally determined to impact the chosen outcome.ObjectiveThe goal of this study is to optimize a standalone text messaging obesity intervention, Charge, using the MOST framework to experimentally determine which text messaging components produce a meaningful contribution to weight change at 6 months.MethodsWe designed a 6-month, weight loss texting intervention based on our interactive obesity treatment approach (iOTA). Participants are randomized to one of 32 experimental conditions to test which standalone text messaging intervention components produce a meaningful contribution to weight change at 6 months.ResultsThe project was funded in February 2017; enrollment began in January 2018 and data collection was completed in June 2019. Data analysis is in progress and first results are expected to be submitted for publication in 2021.ConclusionsFull factorial trials are particularly efficient in terms of cost and logistics when leveraged for standalone digital treatments. Accordingly, MOST has the potential to promote the rapid advancement of digital health treatments. Subject to positive findings, the intervention will be low cost, immediately scalable, and ready for dissemination. This will be of great potential use to the millions of Americans with obesity and the providers who treat them.Trial registrationClinicalTrials.gov NCT03254940; https://clinicaltrials.gov/ct2/show/NCT03254940.International registered report identifier (irrid)RR1-10.2196/19506.
| S-EPMC7850907 | biostudies-literature
Project description:ObjectiveIntensive behavioral obesity treatments face scalability challenges, but evidence is lacking about which treatment components could be cut back without reducing weight loss. The Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity (Opt-IN) study applied the Multiphase Optimization Strategy to develop an entirely remotely delivered, technology-supported weight-loss package to maximize the amount of weight loss attainable for ≤$500.MethodsSix-month weight loss was examined among adults (N = 562) with BMI ≥ 25 who were randomly assigned to conditions in a factorial experiment crossing five dichotomous treatment components set to either low/high (12 vs. 24 coaching calls) or off/on (primary care provider reports, text messaging, meal replacements, and buddy training).ResultsAbout 84.3% of participants completed the final assessment. The treatment package yielding maximum weight loss for ≤$500 included 12 coaching calls, buddy training, and primary care provider progress reports; produced average weight loss of 6.1 kg, with 57.1% losing ≥5% and 51.8% losing ≥7%; and cost $427 per person. The most expensive candidate-treatment component (24 vs. 12 coaching calls) was screened out of the optimized treatment package because it did not increase weight loss.ConclusionsSystematically testing each treatment component's effect on weight loss made it possible to eliminate more expensive but less impactful components, yielding an optimized, resource-efficient obesity treatment for evaluation in a randomized controlled trial.
| S-EPMC8045468 | biostudies-literature
Project description:BackgroundBehavioral lifestyle intervention (BLI) is recommended as a first-line treatment for obesity. While BLI has been adapted for online delivery to improve potential for dissemination while reducing costs and barriers to access, weight losses are typically inferior to gold standard treatment delivered in-person. It is therefore important to refine and optimize online BLI in order to improve the proportion of individuals who achieve a minimum clinically significant weight loss and mean weight loss.Study designFive experimental intervention components will be tested as adjuncts to an established 12-month online BLI: virtual reality for BLI skills training, interactive video feedback, tailored intervention to promote physical activity, skills for dysregulated eating, and social support combined with friendly competition. Following the Multiphase Optimization Strategy (MOST) framework, the components will first be refined and finalized during Preparation Phase pilot testing and then evaluated in a factorial experiment with 384 adults with overweight or obesity. A priori optimization criteria that balance efficacy and efficiency will be used to create a finalized treatment package that produces the best weight loss outcomes with the fewest intervention components. Mediation analysis will be conducted to test hypothesized mechanisms of action and a moderator analysis will be conducted to understand for whom and under what circumstances the interventions are effective.ConclusionThis study will provide important information about intervention strategies that are useful for improving outcomes of online BLI. The finalized treatment package will be suitable for testing in a future randomized trial in the MOST Evaluation Phase.
| S-EPMC7887033 | biostudies-literature
Project description:BACKGROUND:Delivery of behavioral interventions is complex, as the majority of interventions consist of multiple components used either simultaneously, sequentially, or both. The importance of clearly delineating delivery strategies within these complex interventions-and furthermore understanding the impact of each strategy on effectiveness-has recently emerged as an important facet of intervention research. Yet, few methodologies exist to prospectively test the effectiveness of delivery strategies and how they impact implementation. In the current paper, we describe a study protocol for a large randomized controlled trial in which we will use the Multiphase Optimization Strategy (MOST), a novel framework developed to optimize interventions, i.e., to test the effectiveness of intervention delivery strategies using a factorial design. We apply this framework to delivery of Family Navigation (FN), an evidence-based care management strategy designed to reduce disparities and improve access to behavioral health services, and test four components related to its implementation. METHODS/DESIGN:The MOST framework contains three distinct phases: Preparation, Optimization, and Evaluation. The Preparation phase for this study occurred previously. The current study consists of the Optimization and Evaluation phases. Children aged 3-to-12 years old who are detected as "at-risk" for behavioral health disorders (n?=?304) at a large, urban federally qualified community health center will be referred to a Family Partner-a bicultural, bilingual member of the community with training in behavioral health and systems navigation-who will perform FN. Families will then be randomized to one of 16 possible combinations of FN delivery strategies (2 × 2 × 2× 2 factorial design). The primary outcome measure will be achieving a family-centered goal related to behavioral health services within 90?days of randomization. Implementation data on the fidelity, acceptability, feasibility, and cost of each strategy will also be collected. Results from the primary and secondary outcomes will be reviewed by our team of stakeholders to optimize FN delivery for implementation and dissemination based on effectiveness, efficiency, and cost. DISCUSSION:In this protocol paper, we describe how the MOST framework can be used to improve intervention delivery. These methods will be useful for future studies testing intervention delivery strategies and their impact on implementation. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03569449. Registered on 26 June 2018.
| S-EPMC6915979 | biostudies-literature
Project description:BackgroundMore than half of persons living with HIV (PLWH) in the United States are insufficiently engaged in HIV primary care and not taking antiretroviral therapy (ART), mainly African Americans/Blacks and Hispanics. In the proposed project, a potent and innovative research methodology, the multiphase optimization strategy (MOST), will be employed to develop a highly efficacious, efficient, scalable, and cost-effective intervention to increase engagement along the HIV care continuum. Whereas randomized controlled trials are valuable for evaluating the efficacy of multi-component interventions as a package, they are not designed to evaluate which specific components contribute to efficacy. MOST, a pioneering, engineering-inspired framework, addresses this problem through highly efficient randomized experimentation to assess the performance of individual intervention components and their interactions. We propose to use MOST to engineer an intervention to increase engagement along the HIV care continuum for African American/Black and Hispanic PLWH not well engaged in care and not taking ART. Further, the intervention will be optimized for cost-effectiveness. A similar set of multi-level factors impede both HIV care and ART initiation for African American/Black and Hispanic PLWH, primary among them individual- (e.g., substance use, distrust, fear), social- (e.g., stigma), and structural-level barriers (e.g., difficulties accessing ancillary services). Guided by a multi-level social cognitive theory, and using the motivational interviewing approach, the study will evaluate five distinct culturally based intervention components (i.e., counseling sessions, pre-adherence preparation, support groups, peer mentorship, and patient navigation), each designed to address a specific barrier to HIV care and ART initiation. These components are well-grounded in the empirical literature and were found acceptable, feasible, and promising with respect to efficacy in a preliminary study.Methods/designStudy aims are: 1) using a highly efficient fractional factorial experimental design, identify which of five intervention components contribute meaningfully to improvement in HIV viral suppression, and secondary outcomes of ART adherence and engagement in HIV primary care; 2) identify mediators and moderators of intervention component efficacy; and 3) using a mathematical modeling approach, build the most cost-effective and efficient intervention package from the efficacious components. A heterogeneous sample of African American/Black and Hispanic PLWH (with respect to age, substance use, and sexual minority status) will be recruited with a proven hybrid sampling method using targeted sampling in community settings and peer recruitment (N = 512).DiscussionThis is the first study to apply the MOST framework in the field of HIV prevention and treatment. This innovative study will produce a culturally based HIV care continuum intervention for the nation's most vulnerable PLWH, optimized for cost-effectiveness, and with exceptional levels of efficacy, efficiency, and scalability.Trial registrationClinicalTrials.gov, NCT02801747 , Registered June 8, 2016.
| S-EPMC5418718 | biostudies-literature
Project description:Behavioral weight loss treatment (BT) for individuals with overweight and obesity is effective but leaves room for improvement. Mindfulness and acceptance-based treatments may bolster weight loss outcomes; yet, little is known about the efficacy of the individual components or the combinations of components that are most effective in producing weight loss above and beyond standard BT strategies for weight loss. This protocol manuscript describes the use of a multiphase optimization strategy to evaluate the independent and combinatory efficacy of three mindfulness and acceptance-based components (mindful awareness, willingness, values). Using a 2 × 2 × 2 factorial design, participants (N = 288) will be randomized to one of eight conditions, each representing a combination of core MABT strategies in addition to foundational BT strategies. Assessments occur at baseline, mid-treatment (week 24 through 26), post-treatment, and at 6, 12, and 24-month follow-up. The primary aim is to elucidate the independent efficacy of each MABT component on weight loss above gold-standard BT. The secondary aims are to evaluate the independent effect of these components on calorie intake, physical activity, and overall quality of life; evaluate target engagement (i.e., the degree to which each treatment component affects proposed mechanisms of action); and evaluate the potential moderating effect of susceptibility to internal and external food cues on outcomes. The exploratory aim is to quantify any component interaction effects (which may be synergistic, fully additive, or partially additive).
| S-EPMC8722456 | biostudies-literature
Project description:BackgroundAsthma causes substantial morbidity and mortality in the United States, particularly among African American emerging adults (AAEAs; aged 18-30 years), but very few asthma programs have targeted this population. Interventions that provide education and address underlying motivation for managing asthma may be the most effective. However, intensive face-to-face interventions are often difficult to implement in this population.ObjectiveThe purpose of this study is to develop an effective mobile asthma management intervention to improve control among AAEAs.MethodsWe will assess the ability of multiple technologic components to assist and improve traditional asthma education. The first component is the Motivational Enhancement System for asthma management. It is a mobile 4-session intervention using supported self-regulation and motivational interviewing. Personalized content is based on each participant's activity level, daily experiences, and goals. The second component is supportive accountability. It is administered by asthma nurses using targeted mobile support (Skype/voice calls) to provide education, promote self-efficacy, and overcome barriers through a motivational interviewing-based framework. The third component is SMS text messaging. It provides reminders for asthma education, medication adherence, and physical activity. The fourth component is physical activity tracking. It uses wearable technology to help meet user-defined physical activity goals. Using a multiphase optimization strategy (MOST) framework, we will test intervention components and combinations of components to identify the most effective mobile intervention. The MOST framework is an innovative, and cost- and time-effective framework that uses engineering principles to produce effective behavioral interventions. We will conduct a component selection experiment using a factorial research design to build an intervention that has been optimized for maximum efficacy, using a clinically significant improvement in asthma. Participants (N=180) will be randomized to 1 of 6 intervention arms. Participants will be recruited from multiple sites of the American Lung Association-Airway Clinical Research Centers network and ambulatory care clinics at the Detroit Medical Center. Data collections will occur at baseline, and 3, 6, and 12 months.ResultsAt study completion, we will have an empirically supported optimized mobile asthma management intervention to improve asthma control for AAEAs. We hypothesize that postintervention (3, 6, and 12 months), participants with uncontrolled asthma will show a clinically significant improvement in asthma control. We also hypothesize that improvements in asthma management behaviors (including physical activity), quality of life, symptoms, adherence, and exacerbation (secondary outcomes) will be observed.ConclusionsAAEAs are disproportionately impacted by asthma, but have been underrepresented in research. Mobile asthma management interventions may help improve asthma control and allow people to live healthier lives. During this project, we will use an innovative strategy to develop an optimized mobile asthma management intervention using the most effective combination of nurse-delivered asthma education, a smartphone app, and text messaging.International registered report identifier (irrid)PRR1-10.2196/37946.
| S-EPMC9131162 | biostudies-literature
Project description:Recent systematic reviews and meta-analyses have reported positive benefit of multicomponent "bundled" palliative care interventions for patients and family caregivers while highlighting limitations in determining key elements and mechanisms of improvement. Traditional research approaches, such as the randomized controlled trial (RCT), typically treat interventions as "bundled" treatment packages, making it difficult to assess definitively which aspects of an intervention can be reduced or replaced or whether there are synergistic or antagonistic interactions between intervention components. Progressing toward palliative care interventions that are effective, efficient, and scalable will require new strategies and novel approaches. One such approach is the Multiphase Optimization Strategy (MOST), a framework informed by engineering principles, that uses a systematic process to empirically identify an intervention comprised of components that positively contribute to desired outcomes under real-life constraints. This article provides a brief overview and application of MOST and factorial trial design in palliative care research, including our insights from conducting a pilot factorial trial of an early palliative care intervention to enhance the decision support skills of advanced cancer family caregivers (Project CASCADE).
| S-EPMC8274323 | biostudies-literature
Project description:Weight loss and physical activity are the cornerstones of therapy for type 2 diabetes. However, providing an effective lifestyle intervention is difficult because of limited availability of reliable programs, patient inconvenience, and cost. A worksite setting provides a unique opportunity for lifestyle therapy because it reduces these barriers. We conducted an 8-month randomized controlled trial in persons with obesity and diabetes to determine the therapeutic effects and potential mechanisms of intensive-lifestyle-therapy (energy restriction and supervised exercise training) conducted at the worksite. Intensive-lifestyle-therapy resulted in marked (17%) weight loss, associated with beneficial changes in body composition, cardiorespiratory fitness, muscle strength, glycemic control, β-cell function and insulin sensitivity in the liver, adipose tissue, and skeletal muscle, despite a decrease in diabetes medication use. These beneficial effects were associated with changes in skeletal muscle (increased metabolite content and expression of genes involved in NAD biosynthesis, sirtuin signaling, and mitochondrial biogenesis and function), adipose tissue (decreased expression of genes involved in extracellular matrix remodeling), and a major plasma mediator of insulin resistance (decreased plasma PAI-1). These findings demonstrate that effective intensive-lifestyle-therapy can be implemented at the worksite, and has profound therapeutic, clinical, physiological, and cellular effects in people with obesity and type 2 diabetes.
2022-09-08 | GSE205891 | GEO
Project description:BackgroundFamily caregiver interventions are essential to support dementia caregiving. However, such interventions are typically complex and consist of multiple components. Existing evidence rarely delineates the effectiveness and interactions between individual components. To optimise intervention, we adopt the multiphase optimisation strategy (MOST) to test the implementation fidelity and determine the effect of each component and the interactions between each component and the corresponding outcome.MethodsA prospective, assessor-blinded, randomised clinical trial with fractional factorial design using the MOST principle. Two hundred fifty family dementia caregivers will be randomised to one of 16 experimental conditions in a fractional factorial design involving six intervention components: (1) dementia and caregiving education; (2) self-care skills; (3) behavioural symptom management; (4) behavioural activation; (5) modified mindfulness-based cognitive therapy; and (6) support group. The first one is the core component, and the five remaining will be examined. Physical health, caregiver burden, stress, psychological well-being, anxiety and depressive symptoms, and social support will be assessed over the 12-month study period. Following the intention-to-treat principle, linear mixed models and regression analyses will be used to examine the specific effect of the five components and their two-way interactions to propose the most effective combination.DiscussionThis is the first study adopting the multiphase optimisation strategy to identify the most active and engaging components of a psychological intervention for caregivers of patients with dementia. In view that dementia caregiver interventions are increasingly diversified and complex, such knowledge is important to maximise the intervention efficacy and allow the intervention to be implemented within an efficient timeframe and dosage. The optimisation of caregiver support interventions is critical to enhance the health outcomes of caregivers and care recipients, thereby, delaying possible institutionalisation and reducing the costs of long-term dementia care.Trial registrationThis study was retrospectively registered in the WHO Primary Registry - Chinese Clinical Trials Registry (ChiCTR2300071235). (Protocol date 30/10/2020; version identifier 2020-2021-0045). Registered on 9 May, 2023.Reporting methodSPIRIT guideline was followed.Patient or public contributionNo patient or public involvement.
| S-EPMC10696816 | biostudies-literature