研究多组分移动健康身体活动、饮食和睡眠干预对超重和肥胖成年人减肥的效果：随机对照试验方案

Examining the efficacy of a multicomponent m-Health physical activity, diet and sleep intervention for weight loss in overweight and obese adults: randomised controlled trial protocol.

作者信息

Duncan Mitch J, Brown Wendy J, Burrows Tracy L, Collins Clare E, Fenton Sasha, Glozier Nicholas, Kolt Gregory S, Morgan Philip J, Hensley Michael, Holliday Elizabeth G, Murawski Beatrice, Plotnikoff Ronald C, Rayward Anna T, Stamatakis Emmanuel, Vandelanotte Corneel

机构信息

Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Newcastle, New South Wales, Australia.

School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, New South Wales, Australia.

出版信息

BMJ Open. 2018 Oct 30;8(10):e026179. doi: 10.1136/bmjopen-2018-026179.

DOI:10.1136/bmjopen-2018-026179

PMID:30381313

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6224765/

Abstract

INTRODUCTION

Traditional behavioural weight loss trials targeting improvements in physical activity and diet are modestly effective. It has been suggested that sleep may have a role in weight loss and maintenance. Improving sleep health in combination with physical activity and dietary behaviours may be one strategy to enhance traditional behavioural weight loss trials. Yet the efficacy of a weight loss intervention concurrently targeting improvements in physical activity, dietary and sleep behaviours remains to be tested.

METHODS AND ANALYSIS

The primary aim of this three-arm randomised controlled trial is to examine the efficacy of a multicomponent m-Health behaviour change weight loss intervention relative to a waitlist control group. The secondary aims are to compare the relative efficacy of a physical activity, dietary behaviour and sleep intervention (enhanced intervention), compared with a physical activity and dietary behaviour only intervention (traditional intervention), on the primary outcome of weight loss and secondary outcomes of waist circumference, glycated haemoglobin, physical activity, diet quality and intake, sleep health, eating behaviours, depression, anxiety and stress and quality of life. Assessments will be conducted at baseline, 6 months (primary endpoint) and 12 months (follow-up). The multicomponent m-Health intervention will be delivered using a smartphone/tablet 'app', supplemented with email and SMS and individualised in-person dietary counselling. Participants will receive a Fitbit, body weight scales to facilitate self-monitoring, and use the app to access educational material, set goals, self-monitor and receive feedback about behaviours. Generalised linear models using an analysis of covariance (baseline adjusted) approach will be used to identify between-group differences in primary and secondary outcomes, following an intention-to-treat principle.

ETHICS AND DISSEMINATION

The Human Research Ethics Committee of The University of Newcastle Australia provided approval: H-2017-0039. Findings will be disseminated via publication in peer-reviewed journals, conference presentations, community presentations and student theses.

TRIAL REGISTRATION NUMBER

ACTRN12617000735358; UTN1111-1219-2050.

摘要

引言

以改善身体活动和饮食为目标的传统行为减肥试验效果一般。有人提出，睡眠可能在减肥和维持体重方面发挥作用。将改善睡眠健康与身体活动及饮食行为相结合，可能是增强传统行为减肥试验效果的一种策略。然而，同时针对改善身体活动、饮食和睡眠行为的减肥干预措施的效果仍有待检验。

方法与分析

这项三臂随机对照试验的主要目的是检验多成分移动健康行为改变减肥干预措施相对于等待名单对照组的效果。次要目的是比较身体活动、饮食行为和睡眠干预（强化干预）与仅进行身体活动和饮食行为干预（传统干预）在减肥主要结局以及腰围、糖化血红蛋白、身体活动、饮食质量和摄入量、睡眠健康、饮食行为、抑郁、焦虑、压力和生活质量等次要结局方面的相对效果。评估将在基线、6个月（主要终点）和12个月（随访）时进行。多成分移动健康干预将通过智能手机/平板电脑“应用程序”实施，并辅以电子邮件、短信以及个性化的面对面饮食咨询。参与者将获得一个Fitbit手环、体重秤以方便自我监测，并使用该应用程序获取教育材料、设定目标、自我监测并接收行为反馈。将采用协方差分析（基线调整）方法的广义线性模型，按照意向性分析原则确定主要和次要结局的组间差异。