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

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. CLINICALTRIAL ClinicalTrials.gov NCT01814072; https://clinicaltrials.gov/ct2/show/NCT01814072

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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

JMIR Formative Research ◽

10.2196/16297 ◽

2020 ◽

Vol 4 (5) ◽

pp. e16297

Author(s):

Angela Fidler Pfammatter ◽

Sara Hoffman Marchese ◽

Christine Pellegrini ◽

Elyse Daly ◽

Miriam Davidson ◽

...

Keyword(s):

Weight Loss ◽

Pilot Study ◽

Conceptual Model ◽

Overweight And Obesity ◽

Text Messages ◽

Optimization Strategy ◽

Multiphase Optimization Strategy ◽

Study Results ◽

Preparation Phase ◽

Treatment Package

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

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Evaluating the efficacy of mindfulness and acceptance-based treatment components for weight loss: Protocol for a multiphase optimization strategy trial

Contemporary Clinical Trials ◽

10.1016/j.cct.2021.106573 ◽

2021 ◽

pp. 106573

Author(s):

Evan M. Forman ◽

Christina Chwyl ◽

Michael P. Berry ◽

Lauren C. Taylor ◽

Meghan L. Butryn ◽

...

Keyword(s):

Weight Loss ◽

Optimization Strategy ◽

Multiphase Optimization Strategy

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Engineering a Mobile Platform to Promote Sleep in the Pediatric Primary Care Setting

10.1101/2020.11.06.20223719 ◽

2020 ◽

Author(s):

Jonathan A. Mitchell ◽

Knashawn H. Morales ◽

Ariel A. Williamson ◽

Nicholas Huffnagle ◽

Casey Eck ◽

...

Keyword(s):

Sleep Duration ◽

Mobile Health ◽

Care Setting ◽

Optimization Strategy ◽

Normative Feedback ◽

Promising Candidate ◽

Multiphase Optimization Strategy ◽

Control Gain ◽

Preparation Phase ◽

Control Loss

AbstractBackgroundPediatricians lack tools to support families at home for the promotion of childhood sleep. We are using the Multiphase Optimization Strategy (MOST) framework to guide the development of a mobile health platform for childhood sleep promotion.PurposeUnder the preparation phase of the MOST framework, to demonstrate feasibility of a mobile health platform towards treating children with insufficient sleep.MethodsChildren aged 10-12y were enrolled (Study #1: N=30; Study #2: N=43). Participants wore a sleep tracker to measure sleep duration. Data were retrieved by a mobile health platform, programmed to send introductory messages during run-in (2 weeks) and goal achievement messages during intervention (7 weeks) periods. In study #1, participants were randomized to control, gain-framed incentive or loss-framed incentive arms. In study #2, participants were randomized to control, loss-framed incentive, normative feedback or loss-framed incentive plus normative feedback arms.ResultsIn study #1, 1,514 nights of data were captured (69%) and sleep duration during the intervention was higher by an average of 21 (95% CI: -8, 51) and 34 (95% CI: 7, 61) minutes per night for the gain-framed and loss-framed arms, respectively, compared to controls. In study #2, 2,689 nights of data were captured (81%), with no major differences in average sleep duration between the control and the loss-framed or normative feedback arms.ConclusionWe have developed and deployed a mobile health platform that can capture sleep data and remotely communicate with families. Promising candidate intervention components will be further investigated under the optimization phase of the MOST framework.

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The preparation phase in the multiphase optimization strategy (MOST): a systematic review and introduction of a reporting checklist

Translational Behavioral Medicine ◽

10.1093/tbm/ibab146 ◽

2021 ◽

Author(s):

Ryan R Landoll ◽

Sara E Vargas ◽

Kristen B Samardzic ◽

Madison F Clark ◽

Kate Guastaferro

Keyword(s):

Systematic Review ◽

Behavioral Interventions ◽

Intervention Development ◽

Future Research ◽

Optimization Strategy ◽

Design Elements ◽

Alternative Intervention ◽

Multiphase Optimization Strategy ◽

Preparation Phase ◽

Almost All

Abstract Multicomponent behavioral interventions developed using the multiphase optimization strategy (MOST) framework offer important advantages over alternative intervention development models by focusing on outcomes within constraints relevant for effective dissemination. MOST consists of three phases: preparation, optimization, and evaluation. The preparation phase is critical to establishing the foundation for the optimization and evaluation phases; thus, detailed reporting is critical to enhancing rigor and reproducibility. A systematic review of published research using the MOST framework was conducted. A structured framework was used to describe and summarize the use of MOST terminology (i.e., preparation phase and optimization objective) and the presentation of preparation work, the conceptual model, and the optimization. Fifty-eight articles were reviewed and the majority focused on either describing the methodology or presenting results of an optimization trial (n = 38, 66%). Although almost all articles identified intervention components (96%), there was considerable variability in the degree to which authors fully described other elements of MOST. In particular, there was less consistency in use of MOST terminology. Reporting on the MOST preparation phase is varied, and there is a need for increased focus on explicit articulation of key design elements and rationale of the preparation phase. The proposed checklist for reporting MOST studies would significantly advance the use of this emerging methodology and improve implementation and dissemination of MOST. Accurate reporting is essential to reproducibility and rigor of scientific trials as it ensures future research fully understands not only the methodology, but the rationale for intervention and optimization decisions.

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Developing mHealth Interventions with Implementation in Mind: Application of the Multiphase Optimization Strategy (MOST) Preparation Phase to Diabetes Prevention Programming (Preprint)

10.2196/preprints.36143 ◽

2022 ◽

Author(s):

Megan MacPherson ◽

Kohle Merry ◽

Sean Locke ◽

Mary Jung

Keyword(s):

Phase I ◽

Conceptual Model ◽

Diabetes Prevention ◽

Healthcare Providers ◽

Intervention Development ◽

Diabetes Prevention Program ◽

Optimization Strategy ◽

Mhealth Intervention ◽

Multiphase Optimization Strategy ◽

The Impact

UNSTRUCTURED With thousands of mHealth solutions on the market, patients and healthcare providers struggle to identify which solution to use/prescribe. The lack of evidence-based mHealth solutions may be due to limited research on intervention development and continued use of traditional research methods for mHealth evaluation. The Multiphase Optimization Strategy (MOST) is a framework which aids in developing interventions which are economical, affordable, scalable, and effective (EASE). MOST Phase I highlights the importance of formative intervention development, a stage often overlooked and rarely published. The aim of MOST Phase I is to identify candidate intervention components, create a conceptual model, and define the optimization objective. While MOST sets these three targets, the framework itself does not provide robust guidance on how to conduct quality research within Phase I, and what 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 MOST within the field of implementation science, this paper provides an account of the methods used to develop an mHealth intervention. Specifically, we provide a comprehensive example of how to achieve the goals of MOST Phase I by outlining the formative development of an mHealth prompting intervention within a diabetes prevention program. Additionally, recommendations are proposed for future researchers to conduct formative research on mHealth interventions with implementation in mind. Given its considerable reach, mHealth has the potential to positively impact public health by decreasing implementation costs and improving accessibility. 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 MOST Phase I, this work can may guide future intervention developers towards maximizing the impact of mHealth outside of the research laboratory.

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Implementation of a text message intervention to promote behavioural change and weight loss among overweight and obese Brazilian primary care patients

Journal of Telemedicine and Telecare ◽

10.1177/1357633x18782092 ◽

2018 ◽

Vol 25 (8) ◽

pp. 476-483 ◽

Cited By ~ 2

Author(s):

Lorenn L Gusmão ◽

Antonio L Ribeiro ◽

Maíra Viana Rego Souza-Silva ◽

Paulo R Gomes ◽

Alline M Beleigoli ◽

...

Keyword(s):

Primary Care ◽

Weight Loss ◽

Pilot Study ◽

Behavioural Change ◽

Text Message ◽

Text Messages ◽

Wilcoxon Test ◽

Message Delivery ◽

Belo Horizonte ◽

Text Message Intervention

Introduction Mobile-technology-based interventions are promising strategies for promoting behavioural change in obese patients. The aims of this study were to evaluate the feasibility of implementing a text message intervention, and to assess the effects of the intervention on body mass index (BMI) and self-reported behavioural change. Methods TELEFIT was a three-phase feasibility study comprising the following stages: (a) the development of text messages; (b) testing; and (c) a quasi-experimental pilot study in which patients who were engaged in obesity/overweight educational groups in public primary care centres in Belo Horizonte, Brazil, were recruited. A bank of text messages was drafted and reviewed by an expert panel, text message delivery software was developed and tested, and a pilot study assessed patients before and after receiving the intervention using validated questionnaires and body measures. The data were analysed using the Wilcoxon test. Results A total of 46 patients completed the follow-up; 93.5% were women and the median age was 42 years (interquartile range (IQR) 34–52 years). At four months, participants had a significant reduction in BMI (median 31.3 (IQR 28.2–34.6) vs. 29.9 (IQR 27.2–34.6) kg/m2, p < 0.001), systolic (median 125 (IQR 120–132) vs. 120 (IQR 110–130) mmHg, p = 0.013) and diastolic blood pressure (median 80 (IQR 70–100) vs. 80 (IQR 70–80) mmHg, p = 0.006), when compared to baseline. All patients reported to be satisfied and willing to continue receiving the intervention, and 93.3% felt that the intervention helped them change their behaviours. Discussion This study has shown that a text message intervention to promote behavioural change and weight loss was feasible and effective in a short-term period. Participants were satisfied and willing to continue receiving the SMS messages.

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Changes in biomarkers and DNA methylation in breast cancer survivors enrolled in the ENERGY weight loss trial: A pilot study.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.3_suppl.181 ◽

2016 ◽

Vol 34 (3_suppl) ◽

pp. 181-181

Author(s):

Wendy Demark-Wahnefried ◽

Cheryl L Rock ◽

Rebecca L. Sedjo ◽

Adetunji Toriola ◽

Jingxia Liu ◽

...

Keyword(s):

Breast Cancer ◽

Dna Methylation ◽

Weight Loss ◽

Pilot Study ◽

Cancer Survivors ◽

Breast Cancer Survivors ◽

Small Sample ◽

Related Protein ◽

Intensive Intervention ◽

Study Results

181 Background: In 2014, an ASPO position statement was released calling for action regarding cancer survivors’ needs for weight management. Reduction of body weight is hypothesized to affect several cancer-related biological pathways. Methods: The Exercise and Nutrition to Enhance Recovery and Good health for You (ENERGY) trial is the largest weight loss trial completed to date among breast cancer survivors. In it, 692 stage Ic-IIIc breast cancer survivors were randomized to an intensive, group-based weight loss intervention with 26 contacts over one year or to a non-intensive intervention with two contacts over the same time period. Results recently reported in JCO showed significantly greater weight loss in the intensive intervention arm compared to the non-intensive arm. A pilot study exploring baseline to 6-month changes in gene methylation and expressed biomarkers was undertaken in 30 chemo-naïve, post-menopausal, non-Hispanic white women who participated in this study. Results: Several significant differences in mean change scores (standard error) between the intensive vs. non-intensive groups were noted, i.e., insulin: -4.19(0.80) vs. 0.42 (1.01)/p = 0.0016; c-peptide: -0.49(0.14) vs. 0.40(0.19)/p = 0.0009; leptin: -15.73(1.79) vs. 2.53(1.78)/p < 0.0001; adiponectin:leptin ratio: 0.67(0.15) vs. 0.010(0.064)/p = 0.0007; homeostasis model of insulin resistance (HOMA-IR): 20.00(4.65) vs. 9.57(5.00)/p = 0.0003; sex hormone binding globulin 20.45(4.61) vs. 8.65(8.00)/p = 0.023; and Follistatin-Related Protein-3 (FSTL3): 0.48(0.19) vs. -0.88(0.55)/p = 0.0497. While effects were in the direction hypothesized for c-reactive protein, interleukin-6, vascular endothelial growth factor, and tumor necrosis factor no significant differences were noted. Significant differences in DNA methylation also were noted for genes encoding for Follistatin Related Protein (corresponds to FSTL3), and those on hormonal/growth pathways (e.g., AMOTL1, ESR, EGR3), inflammatory pathways (e.g., TNFRS10A/TRAIL-R1, C14orf106), and metabolic pathways (e.g., ZBED3, GABRA). Conclusions: While results are based on a small sample and not corrected for multiple testing, they provide evidence that weight loss affects several biomarkers and pathways that impact cancer and which warrant further investigation. Clinical trial information: NCT01112839.

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