Department of Internal Medicine, VA Ann Arbor Healthcare System, Ann Arbor, Michigan, USA
University of Michigan Medical School, Ann Arbor, Michigan, USA.
BMJ Open. 2020 Jan 21;10(1):e033397. doi: 10.1136/bmjopen-2019-033397.
(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.
Single-arm, mixed methods (ie, integration of quantitative and qualitative data) pilot study.
Primary care clinic within a large academic medical centre in the USA.
Adults with pre-diabetes and Body Mass Index of ≥25 kg/m.
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.
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).
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.
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.
NCT03258918.
(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。
单臂、混合方法（即整合定量和定性数据）的试点研究。
美国一家大型学术医疗中心的初级保健诊所。
患有前驱糖尿病和 BMI 大于等于 25kg/m 的成年人。
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）。
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。
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。
NCT03258918。
