Motivational interviewing to promote healthy behaviors for obesity prevention in young adults (MOTIVATE): a pilot randomized controlled trial protocol

Abstract

Background: Obesity is a chronic disease and is an established risk factor for other chronic diseases and mortality. Young adulthood is a period when people may be highly amenable to healthy behavior change, develop lifelong healthy behaviors, and when primary prevention of obesity may be feasible. Interventions in early adulthood have the potential for primary or primordial prevention (i.e., preventing risk factors before disease onset). The primary objective of this study is to determine the feasibility of a 6-month behavioral and educational intervention to promote healthy behaviors for obesity prevention among young adults. Methods: This is the study protocol for a pilot randomized controlled trial. Young adults (age 18–29) attending McMaster University, Hamilton, Canada, will be recruited and randomized to either the intervention or control. The intervention will include individual motivational interviewing sessions (online or in-person) with a trained interviewer plus educational materials (based on Canada’s food guide and physical activity recommendations). The control group will receive educational materials only. The primary feasibility outcomes that will be evaluated as part of this pilot study include enrollment, retention (≥ 80%), data completion (≥ 80% of weights measured, and surveys completed), and participant satisfaction. Secondary clinical outcomes will include body mass index (BMI) change from baseline to 6 months, physical activity, nutrition risk, health-related quality of life mental health, and economic outcomes. Outcomes will be measured remotely using activity trackers, and online questionnaires at baseline and every 2 months. Risk stratification will be applied at baseline to identify participants at high risk of obesity (e.g., due to family or personal history). Exit questionnaires will collect data on how participants felt about the study and cost analysis will be conducted. Discussion: Our pilot randomized controlled trial will evaluate the feasibility of an obesity prevention intervention in early adulthood and will inform future larger studies for obesity prevention. The results of this study have the potential to directly contribute to the primary prevention of several types of cancer by testing an intervention that could be scalable to public health, post-secondary education, or primary care settings. Trial registration: https://clinicaltrials.gov/ct2/show/NCT05264740 . Registered on March 3, 2022.