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

社交移动减肥方法 (SMART) 2.0:针对大学环境中的年轻人的随机对照试验方案

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作者:Shadia J Mansour-Assi, Natalie M Golaszewski, Victoria Lawhun Costello, David Wing, Hailey Persinger, Aaron Coleman, Leslie Lytle, Britta A Larsen, Sonia Jain, Nadir Weibel, Cheryl L Rock, Kevin Patrick, Eric Hekler, Job G Godino

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

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.

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.

Trial registration

ClinicalTrials.gov NCT03907462 . Registered on April 9, 2019.

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