A randomized controlled trial for reduction of risk factors for cardiovascular disease in young adults: Methods of the Aspire study

Abstract

Background: Being overweight or obese is a large public health problem, especially in the African American/Black and Hispanic communities. Having a body mass index (BMI) > 25 can lead to chronic health conditions, such as heart disease, stroke, and type 2 diabetes. The transition into adulthood may be an excellent time to intervene due to young adults gaining independence; however, little research has focused on community college students and weight change. The purpose of this randomized controlled trial is to test the efficacy of an intervention tool that is personalized for weight loss through healthy eating and increased physical activity in Black and Hispanic community college students.

Methods: Community college students who identify as Black or Hispanic (N = 256) will be recruited and randomized 1:1 to a 12-month, health coach and smartphone application (app) driven intervention or an attention-control condition. The intervention is implemented by health coaches, trained in a health coach specialty program at a university. The intervention includes a Smartphone app for tracking dietary intake, a Fitbit Inspire 2 for tracking physical activity, and daily personalized text messages from a health coach. The main outcome is percent weight loss at 6- and 12-month follow-up assessments. Secondary outcomes include self-efficacy for eating and physical activity, adherence to self-monitoring, Healthy Eating Index scores, and physical activity levels.

Discussion: If the intervention is demonstrated to be efficacious, broader dissemination across college/university campuses to assist young adults to develop sustainable healthy habits may be possible.

Clinicaltrials: gov Identifier: NCT04412954 R01 Trial Number: 1R01NR018699-02.

Keywords: Lifestyle intervention; Nutrition; Physical activity; Randomized controlled trial.