动机性访谈促进青年成年人预防肥胖的健康行为（MOTIVATE）：一项试点随机对照试验方案

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

作者信息

Anderson Laura N, Alvarez Elizabeth, Incze Taylor, Tarride Jean-Eric, Kwan Matthew, Mbuagbaw Lawrence

机构信息

Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street W, Hamilton, ON, L8S 4L8, Canada.

Child Health Evaluative Sciences, Hospital for Sick Children Research Institute, Toronto, ON, Canada.

出版信息

Pilot Feasibility Stud. 2023 Sep 7;9(1):156. doi: 10.1186/s40814-023-01385-0.

DOI:10.1186/s40814-023-01385-0

PMID:37679845

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10483727/

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.

摘要

背景

肥胖是一种慢性疾病，是其他慢性疾病和死亡的既定风险因素。青年期是人们可能非常愿意改变健康行为、养成终身健康行为的时期，也是肥胖一级预防可能可行的时期。成年早期的干预措施具有一级或原级预防的潜力（即在疾病发作前预防风险因素）。本研究的主要目的是确定一项为期6个月的行为和教育干预措施在促进青年成年人预防肥胖的健康行为方面的可行性。

方法

这是一项试点随机对照试验的研究方案。将招募加拿大汉密尔顿麦克马斯特大学的青年成年人（年龄18 - 29岁），并随机分为干预组或对照组。干预措施将包括与经过培训的访谈员进行个人动机性访谈（在线或面对面）以及教育材料（基于加拿大食物指南和身体活动建议）。对照组将仅接受教育材料。作为这项试点研究的一部分，将评估的主要可行性结果包括入组、留存率（≥80%）、数据完整性（≥80%的体重测量和调查问卷完成）以及参与者满意度。次要临床结果将包括从基线到6个月的体重指数（BMI）变化、身体活动、营养风险、与健康相关的生活质量、心理健康以及经济结果。将使用活动追踪器以及在基线和每2个月进行一次的在线问卷远程测量结果。将在基线时进行风险分层，以识别肥胖高风险参与者（例如，由于家族或个人病史）。退出调查问卷将收集参与者对该研究的感受数据，并将进行成本分析。