Dataset Information

Study protocol for a sequential multiple assignment randomized trial (SMART) to improve physical activity in employed women.

ABSTRACT:

Introduction

Physical activity monitors, motivational text messages, personal calls, and group meetings, have proven to be efficacious physical activity interventions. However, individual participant response to these interventions varies drastically. A SMART design (sequential multiple assignment randomized trial) provides an effective way to test interventions that start with an initial treatment and then transition to an augmented treatment for non-responders. We describe a SMART to determine the most effective adaptive intervention to increase physical activity (steps, moderate-to-vigorous physical activity) and improve cardiovascular health among employed women who are not regularly physically active. The SMART uses combinations of four treatments: 1) enhanced physical activity monitor (Fitbit wearable activity monitor and mobile app with goal setting and physical activity prescription), 2) text messages, 3) personal calls, and 4) group meetings.

Methods

Participants (N = 312) include women ages 18-70 employed at a large academic medical center. Women will be randomized to an initial intervention, either an enhanced physical activity monitor or enhanced physical activity monitor + text messaging. Non-responders to the initial intervention at 2 months will be randomized to either personal calls or groups meetings for the next 6 months. At 8 months, all participants will return to only an enhanced physical activity monitor until their final 12-month assessment.

Discussion

Results of this study will add to the literature on improving physical activity in employed women. This study will identify effective interventions for women who respond to less intensive treatments, while maximizing benefits for those who need a more intensive approach.

SUBMITTER: Buchholz SW

PROVIDER: S-EPMC7242143 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Publications

Study protocol for a sequential multiple assignment randomized trial (SMART) to improve physical activity in employed women.

Buchholz Susan W SW Wilbur JoEllen J Halloway Shannon S Schoeny Michael M Johnson Tricia T Vispute Sachin S Kitsiou Spyros S

Contemporary clinical trials 20191230

<h4>Introduction</h4>Physical activity monitors, motivational text messages, personal calls, and group meetings, have proven to be efficacious physical activity interventions. However, individual participant response to these interventions varies drastically. A SMART design (sequential multiple assignment randomized trial) provides an effective way to test interventions that start with an initial treatment and then transition to an augmented treatment for non-responders. We describe a SMART to d ...[more]

PMID: 31899371

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Project description:BackgroundIntimate partner violence (IPV) disproportionately affects immigrant women, an understudied and underserved population in need for evidence-based rigorously evaluated culturally competent interventions that can effectively address their health and safety needs.MethodsThis study uses a sequential, multiple assignment, randomized trial (SMART) design to rigorously evaluate an adaptive, trauma-informed, culturally tailored technology-delivered intervention tailored to the needs of immigrant women who have experienced IPV. In the first stage randomization, participants are randomly assigned to an online safety decision and planning or a usual care control arm and safety, mental health and empowerment outcomes are assessed at 3-, 6- and 12-months post-baseline. For the second stage randomization, women who do not report significant improvements in safety (i.e., reduction in IPV) and empowerment from baseline to 3 months follow up (i.e., non-responders) are re- randomized to safety and empowerment strategies delivered via text only or a combination of text and phone calls with trained advocates. Data on outcomes (safety, mental health, and empowerment) for early non-responders is assessed at 6 and 12 months post re-randomization.DiscussionThe study's SMART design provides an opportunity to implement and evaluate an individualized intervention protocol for immigrant women based on their response to type or intensity of intervention. The findings will be useful for identifying what works for whom and characteristics of participants needing a particular type or intensity level of intervention for improved outcomes. If found to be effective, the study will result in an evidence-based trauma-informed culturally tailored technology-based safety decision and planning intervention for immigrant survivors of IPV that can be implemented by practitioners serving immigrant women in diverse settings.Trial registrationThis trial was registered with ClinicalTrials.gov as NCT04098276 on September 13, 2019.

Project description:BackgroundThe sequential multiple assignment randomized trial (SMART) design allows for changes in the intervention during the trial period. Despite its potential and feasibility for defining the best sequence of interventions, so far, it has not been utilized in a smartphone/gamified intervention for physical activity.ObjectiveWe aimed to investigate the feasibility of the SMART design for assessing the effects of a smartphone app intervention to improve physical activity in adults. We also aimed to describe the participants' perception regarding the protocol and the use of the app for physical activity qualitatively.MethodsWe conducted a feasibility 24-week/two-stage SMART in which 18 insufficiently active participants (<10,000 steps/day) were first randomized to group 1 (smartphone app only), group 2 (smartphone app + tailored messages), and a control group (usual routine during the protocol). Participants were motivated to increase their step count by at least 2000 steps/day each week. Based on the 12-week intermediate outcome, responders continued the intervention and nonresponders were rerandomized to subsequent treatment, including a new group 3 (smartphone app + tailored messages + gamification) in which they were instructed to form groups to use several game elements available in the chosen app (Pacer). We considered responders as those with any positive slope in the linear relationship between weeks and steps per day at the end of the first stage of the intervention. We compared the accelerometer-based steps per day before and after the intervention, as well as the slopes of the app-based steps per day between the first and second stages of the intervention.ResultsTwelve participants, including five controls, finished the intervention. We identified two responders in group 1. We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group. However, the rerandomization of five nonresponders led to a change in the slope of the steps per day (median -198 steps/day [IQR -279 to -103] to 20 steps/day [IQR -204 to 145]; P=.08). Finally, in three participants from group 2, we observed an increase in the number of steps per day up to the sixth week, followed by an inflection to baseline values or even lower (ie, a quadratic relationship). The qualitative analysis showed that participants' reports could be classified into the following: (1) difficulty in managing the app and technology or problems with the device, (2) suitable response to the app, and (3) difficulties to achieve the goals.ConclusionsThe SMART design was feasible and changed the behavior of steps per day after rerandomization. Rerandomization should be implemented earlier to take advantage of tailored messages. Additionally, difficulties with technology and realistic and individualized goals should be considered in interventions for physical activity using smartphones.Trial registrationBrazilian Registry of Clinical Trials RBR-8xtc9c; http://www.ensaiosclinicos.gov.br/rg/RBR-8xtc9c/.

Dataset Information

Study protocol for a sequential multiple assignment randomized trial (SMART) to improve physical activity in employed women.

Introduction

Methods

Discussion

Publications

Study protocol for a sequential multiple assignment randomized trial (SMART) to improve physical activity in employed women.

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