Social Mobile Approaches to Reducing Weight (SMART) 2.0: protocol of a randomized controlled trial among young adults in university settings

Abstract

Background Excess weight gain in young adulthood is associated with future weight gain and increased risk of chronic disease. Although multimodal, technology-based weight-loss interventions have the potential to promote weight loss among young adults, many interventions have limited personalization, and few have been deployed and evaluated for longer than a year. We aim to assess the effects of a highly personalized, 2-year intervention that uses popular mobile and social technologies to promote weight loss among young adults. Methods The Social Mobile Approaches to Reducing Weight (SMART) 2.0 Study is a 24-month parallel-group randomized controlled trial that will include 642 overweight or obese participants, aged 18–35 years, from universities and community colleges in San Diego, CA. All participants receive a wearable activity tracker, connected scale, and corresponding app. Participants randomized to one intervention group receive evidence-based information about weight loss and behavior change techniques via personalized daily text messaging (i.e., SMS/MMS), posts on social media platforms, and online groups. Participants in a second intervention group receive the aforementioned elements in addition to brief, technology-mediated health coaching. Participants in the control group receive a wearable activity tracker, connected scale, and corresponding app alone. The primary outcome is objectively measured weight in kilograms over 24 months. Secondary outcomes include anthropometric measurements; physiological measures; physical activity, diet, sleep, and psychosocial measures; and engagement with intervention modalities. Outcomes are assessed at baseline and 6, 12, 18, and 24 months. Differences between the randomized groups will be analyzed using a mixed model of repeated measures and will be based on the intent-to-treat principle. Discussion We hypothesize that both SMART 2.0 intervention groups will significantly improve weight loss compared to the control group, and the group receiving health coaching will experience the greatest improvement. We further hypothesize that differences in secondary outcomes will favor the intervention groups. There is a critical need to advance understanding of the effectiveness of multimodal, technology-based weight-loss interventions that have the potential for long-term effects and widespread dissemination among young adults. Our findings should inform the implementation of low-cost and scalable interventions for weight loss and risk-reducing health behaviors. Trial registration ClinicalTrials.govNCT03907462. Registered on April 9, 2019

Exploring boundary conditions of sustained physical activity: insights for the debate on physical activity maintenance

“…We used data from the SMART 2.0 study, a 24-month (96 weeks), three-arm, parallel-group randomized controlled trial targeting weight loss among young adults with overweight or obesity (Mansour-Assi et al, 2022; ClinicalTrials.gov Identifier: NCT03907462). The trial was conducted between April 2019 and February 2024, in San Diego, USA.…”

“…Further details on the intervention content are thoroughly described in the trial protocol (Mansour-Assi et al, 2022).…”

“…First, participants' physical activity at baseline was assessed using the GPAQ, which is different from the approach used to collect time series data (i.e., Fitbit) and is susceptible to typical biases inherent in self-report measures in health-care research, such as recall bias and social desirability bias, among others (Althubaiti, 2016). However, we preferred to adopt this approach instead of other potential solutions to quantify the baseline level (e.g., averaging the first two weeks of Fitbit data) to avoid calculating the baseline level from a period during which the participants were already exposed to the intervention content (see Mansour-Assi et al, 2022) and their physical activity level might have already changed as a result of the intervention.…”

“…According to the SMART 2.0 protocol, we collected this information at baseline and during the 6, 12, 18, and 24month follow-up assessments (see Mansour-Assi et al, 2022), but we did not monitor changes in their intentions using intensive longitudinal methods. Consequently, we lack the ability to determine whether their intentions to achieve a specific level of physical activity changed over time as it has been recommended by previous literature (Dunton et al, 2021).…”

Adult obesity treatment and prevention: A trans‐agency commentary on the research landscape, gaps, and future opportunities

“…also utilize mobile or digital health techniques, such as the Social Mobile Approaches to Reducing Weight (SMART) 2.0 randomized controlled trial for young adults in university settings with overweight or obesity. 16 However, at the time of the 2021 meeting, there were no medication trials, although a multi-site trial investigating the longterm efficacy and safety of phentermine (the LEAP trial) is currently underway. There was only one study on bariatric treatment, which compared the effectiveness of vertical sleeve gastrectomy (VSG) and…”