美国针对糖尿病前期成年人的低碳水化合物糖尿病预防计划的混合方法试点研究。
Mixed methods pilot study of a low-carbohydrate diabetes prevention programme among adults with pre-diabetes in the USA.
机构信息
Department of Internal Medicine, VA Ann Arbor Healthcare System, Ann Arbor, Michigan, USA
University of Michigan Medical School, Ann Arbor, Michigan, USA.
出版信息
BMJ Open. 2020 Jan 21;10(1):e033397. doi: 10.1136/bmjopen-2019-033397.
OBJECTIVES
(1) To estimate weight change from a low-carbohydrate diabetes prevention programme (LC-DPP) and (2) to evaluate the feasibility and acceptability of an LC-DPP.
RESEARCH DESIGN
Single-arm, mixed methods (ie, integration of quantitative and qualitative data) pilot study.
SETTING
Primary care clinic within a large academic medical centre in the USA.
PARTICIPANTS
Adults with pre-diabetes and Body Mass Index of ≥25 kg/m.
INTERVENTION
We adapted the Centers for Disease Control and Prevention's National Diabetes Prevention Program (NDPP)-an evidence-based, low-fat dietary intervention-to teach participants to follow a very low-carbohydrate diet (VLCD). Participants attended 23 group-based classes over 1 year.
OUTCOME MEASURES
Primary outcome measures were (1) weight change and (2) percentage of participants who achieved ≥5% wt loss. Secondary outcome measures included intervention feasibility and acceptability (eg, attendance and qualitative interview feedback).
RESULTS
Our enrolment target was 22. One person dropped out before a baseline weight was obtained; data from 21 individuals were analysed. Mean weight loss in kilogram was 4.3 (SD 4.8) at 6 months and 4.9 (SD 5.8) at 12 months. Mean per cent body weight changes were 4.5 (SD 5.0) at 6 months and 5.2 (SD 6.0) at 12 months; 8/21 individuals (38%) achieved ≥5% wt loss at 12 months. Mean attendance was 10.3/16 weekly sessions and 3.4/7 biweekly or monthly sessions. Among interviewees (n=14), three factors facilitated VLCD adherence: (1) enjoyment of low-carbohydrate foods, (2) diminished hunger and cravings and (3) health benefits beyond weight loss. Three factors hindered VLCD adherence: (1) enjoyment of high-carbohydrate foods, (2) lack of social support and (3) difficulty preplanning meals.
CONCLUSIONS
An LC-DPP is feasible, acceptable and may be an effective option to help individuals with pre-diabetes to lose weight. Data from this pilot will be used to plan a fully powered randomised controlled trial of weight loss among NDPP versus LC-DPP participants.
TRIAL REGISTRATION NUMBER
NCT03258918.
目的
(1) 估计低碳水化合物糖尿病预防计划（LC-DPP）的体重变化，(2) 评估 LC-DPP 的可行性和可接受性。
研究设计
单臂、混合方法（即整合定量和定性数据）的试点研究。
地点
美国一家大型学术医疗中心的初级保健诊所。
参与者
患有前驱糖尿病和 BMI 大于等于 25kg/m 的成年人。
干预措施
我们改编了疾病控制与预防中心的国家糖尿病预防计划（NDPP）——一种基于证据的低脂饮食干预措施——来教导参与者遵循极低碳水化合物饮食（VLCD）。参与者在 1 年内参加了 23 次基于小组的课程。
主要结果
主要结果是（1）体重变化，（2）达到≥5%体重减轻的参与者比例。次要结果包括干预措施的可行性和可接受性（例如，出勤率和定性访谈反馈）。
结果
我们的入组目标是 22 人。在获得基线体重之前，有 1 人退出；对 21 名参与者的数据进行了分析。6 个月时体重平均减轻 4.3（SD 4.8）公斤，12 个月时减轻 4.9（SD 5.8）公斤。6 个月时体重百分比平均变化为 4.5（SD 5.0），12 个月时为 5.2（SD 6.0）；12 个月时，21 人中的 8 人（38%）体重减轻≥5%。平均出勤率为每周 16 次课程的 10.3/次，每两周或每月课程的 7 次的 3.4/次。在接受访谈的 14 名参与者中，有三个因素促进了 VLCD 的依从性：（1）享受低碳水化合物食物，（2）减少饥饿和渴望，（3）减肥以外的健康益处。三个因素阻碍了 VLCD 的依从性：（1）享受高碳水化合物食物，（2）缺乏社会支持，（3）难以提前计划膳食。
结论
LC-DPP 是可行的、可接受的，并且可能是帮助前驱糖尿病患者减肥的有效选择。这项试点研究的数据将用于计划一项针对 NDPP 与 LC-DPP 参与者的减肥的完全随机对照试验。
试验注册号
NCT03258918。
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