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一项在线教育干预对18至45岁糖尿病前期人群体重减轻效果的随机试验方案

Efficacy of an Online Educational Intervention in Reducing Body Weight in the Pre-Diabetic Population of 18-45 Years Old, a Randomized Trial Protocol.

作者信息

Ramírez-Durán María Del Valle, Basilio-Fernández Belinda, Gómez-Luque Adela, Alfageme-García Pilar, Clavijo-Chamorro María Zoraida, Jiménez-Cano Víctor Manuel, Fabregat-Fernández Juan, Robles-Alonso Vicente, Hidalgo-Ruiz Sonia

机构信息

Department of Nursing, University Center of Plasencia, University of Extremadura, 10600 Plasencia, Spain.

Department of Nursing, Faculty of Nursing and Occupational Therapy, University of Extremadura, 10004 Cáceres, Spain.

出版信息

J Pers Med. 2022 Oct 7;12(10):1669. doi: 10.3390/jpm12101669.

Abstract

Aim: to analyze the efficacy of an educational online intervention focused on lifestyle changes in reducing body weight from baseline to 6 months in the pre-diabetic population of 18−45 years old in Extremadura (Spain). Methods: a single-blind, multicenter randomized parallel-comparison trial with two intervention groups in a 1:1 ratio will be carried out. Participants will be randomly assigned to intervention A or B with 37 cases in each group according to inclusion criteria of being enrolled or working at Extremadura University, scoring >7 points on the Findrisc test and not having diagnosed diabetes mellitus or physical disabilities. Intervention-A group will have access to online information about healthy diet and exercise. Intervention-B group will have access to a six-session educational program regarding behavioral changes in diet and exercise habits. They will complete follow-up activities and have a personal trainer and motivation. The primary outcome will be identifying changes in body weight from baseline to 1 and 6 months and between groups. The secondary outcomes will be accomplishing regular physical activity (>30 min/day or >4 h/week), decreasing sugary food intake or avoiding it altogether, increasing vegetable/fruit intake and lowering HbA1c levels to non-diabetic status when necessary.

摘要

目的

分析一项聚焦于生活方式改变的在线教育干预措施,对西班牙埃斯特雷马杜拉地区18至45岁糖尿病前期人群从基线到6个月体重减轻情况的疗效。方法:将开展一项单盲、多中心随机平行对照试验,设置两个干预组,比例为1:1。根据在埃斯特雷马杜拉大学入学或工作、在Findrisc测试中得分>7分且未被诊断患有糖尿病或身体残疾的纳入标准,参与者将被随机分配到干预A组或B组,每组37例。干预A组将可获取有关健康饮食和运动的在线信息。干预B组将可参加一个关于饮食和运动习惯行为改变的六节教育课程。他们将完成后续活动,并配备一名私人教练和提供激励。主要结局将是确定从基线到1个月和6个月以及组间的体重变化。次要结局将是实现规律体育活动(每天>30分钟或每周>4小时)、减少含糖食物摄入量或完全避免食用、增加蔬菜/水果摄入量,并在必要时将糖化血红蛋白水平降至非糖尿病状态。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c1c/9604779/a356638ceaac/jpm-12-01669-g001.jpg

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